Combinate Podcast - Combining Drugs and Devices
By Subhi Saadeh
Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on.
My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers.
Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!
Combinate Podcast - Combining Drugs and DevicesMar 20, 2024
134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch
On this episode, I was joined by Richard Koch, Founder of KochSaMD. Richard discusses:
00:29 Exploring Software's Role in Medical Devices
02:29 Deep Dive into Cloud-Based Medical Devices
06:29 The Intricacies of Software Development in Medical Devices
26:33 The Future of Medical Devices in the Cloud Era
32:56 The Potential Impact of Tech Giants on MedTech
39:50 Embracing Digital Transformation in MedTech
40:50 Closing Thoughts and Where to Find More
Richard Koch is the founder of KochSaMD and is an expert in ISO62304, Medical Device Software and SaMD.
133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell
Devon discusses:
02:20 The Journey to Consulting: A Year of Saying No
03:09 Advising Startups: The Role of a Consultant
05:08 The Shift to Consulting: Embracing Joy and Impact
09:21 Navigating the Startup Ecosystem: Challenges and Opportunities
13:31 Building a Positive Team Culture and Avoiding Arrogance
19:12 The Philosophy Behind Prodct: Focusing on Medical Devices
20:55 A Personal Touch: The Impact of 'Born to Run'
21:59 Closing Thoughts and Where to Find Devon
Devon Campbell is the Founder, Prodct LLC and Chief Product Officer(CPO), myBiometry. He's launched and exited several MedTech ventures and has worked in large Pharma and large IVD companies in executive roles focusing on engineering and product development.
www.devonccampbell.com/
132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner
On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses:
- 00:56 Evolution of Industry Standards
- 02:00 The Impact of Standards on Medical Device Development
- 02:10 Standards and Regulatory Challenges
- 02:42 Standards in Medical Devices and Emerging Technologies
- 13:19 The Auditing Experience
- 17:59 The Challenge of Maintaining and Updating Standards
- 29:49 Concluding Thoughts and Where to Find More Information
Leo Eisner, founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry with product safety compliance & regulatory support. Leo ensures his clients’ medical device compliance needs are met, provides his clients with practical assessments of their products and provides strategies & support to help them through the medical device product compliance maze based on his experience.
He has over 30 years of invaluable experience in the medical device industry. He worked at 3 notified bodies, and his career has spanned over 35 years of product safety certification test lab experience. He worked at 2 internationally recognized labs for 11 years. As an expert in the standards development process, Leo has been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417.
Links:
- Website: https://eisnersafety.com/
- Blog: https://eisnersafety.com/industry_news/ & Sign-up for newsletter on right side of
- page (1/2 way down)
- LinkedIn: linkedin.com/in/leoeisnersafetyconsultants
- Contact Us: https://eisnersafety.com/contact_eisner_safety/
- Schedule a call: https://eisnersafety.com/schedule-call/
- U.S. TAG 62D - https://www.aami.org/detail-pages/opentext-gateway-standards-committee/u.s.-tag-62d---electromedical-equipment-committee
- EV - WG 13 - Lens Removal and Vitrectomy Devices Working Group- https://www.aami.org/detail-pages/opentext-gateway-standards-committee/ev-wg-13---lens-removal-and-vitrectomy-devices-working-group
- JWG 9 Lens removal and vitrectomy devices for ophthalmic surgery - https://www.iec.ch/dyn/www/f?p=103:14:612205979307807::::FSP_ORG_ID,FSP_LANG_ID:2472,25
131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer
- Assessing Drugs, Devices, and Combination Products for Sterility Methods
- Regulatory Frameworks and EMA's Decision Tree (Link)
- Novel Methods: liquid phase sterilization, ionization, physics based sterilization, high pressure sterilization, glass bead sterilization, infrared, microwave
Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.
130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder
On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses:
00:58 Exploring the Impact of QMSR on Medical Device Companies
02:19 UDI Regulations
05:18 Understanding the FDA's Approach to QMSR and Compliance
18:02 The FDA's Inspection Techniques and the Future of QMSR
31:55 Where to Find Aaron and Closing Thoughts
Aaron Snyder is a quality management systems expert and is the VP of QA at Allotex. Prior to joining Allotex, Aaron served in roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. He has worked with a wide range of pharmaceuticals, medical devices and combination products. Aaron is a member of the AAMI Faculty and teaches several courses focused on various QMS topics. Aaron is also and avid content creator and dissects, presents and teaches on QMS and cGMP’s topics on his YouTube channel: Quality Systems Explained.
129 - Reliability for Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens
On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, expect to learn from Alan about how reliability engineering concepts can be used for single use combination products. Why infusion pumps are susceptible to recalls. Why people call Allen captain Allen Stevens. And the roles of standards and guidance in combination product approval.
03:32 The Story Behind 'Captain' Allen Stevens
06:52 The Challenges of Infusion Pumps and Recalls
13:34 The Intricacies of FDA's Rule-making and Guidance Process
21:44 The Future of Reliability in Combination Products
30:46 A Book That Changed Life: Systems Thinking in Safety
32:44 Wrapping Up: The Impact of Engineering on Public Health
Alan is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie within the RA Emerging Technologies, Devices and Combination Products team. Prior to joining AbbVie, Alan spent 20 years at the FDA/CDRH leading premarket review and policy development for drug delivery devices and combination products.
128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture
On this episode, I was joined by Former FDA Investigator and Managing Consultant of Practical Compliance Results, Vin Cafiso.
Vin discusses:
01:35 Journey from Premed to FDA Investigator: VIN's Story
07:25 Understanding the Impact of QMSR on Industry
16:24 The FDA's Approach to Inspections and Compliance
27:45 The Shift Towards Quality Culture in FDA Inspections
31:07 Real-World Insights
35:34 The Impact of Quality Culture on Inspections
44:22 Transitioning from FDA to Industry
49:51 Building a Career in Quality Engineering
Vincent (Vin) Cafiso, serves as the Founder and Managing Consultant of Practical Compliance Solutions. His professional journey commenced as an FDA investigator, after which he transitioned into the industry. Throughout his career, he has held diverse positions at well-established medical device companies such as BD, Smith & Nephew, BioArray Solutions, and Impulse Dynamics. He consults on medical device quality management and can be reached on linkedin here or via the web on https://practicalcomplianceresults.com/about
127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal
On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk".
In this episode, Naveen walks through the big changes to risk management with the QMSR, and risk beyond safety. The episode covers the confusion surrounding the mandatory nature of risk management in particular and we spend the second half of the episode talk about risk acceptability charts, risk & quality policy, explaining vs. justifying risk based decision making with regards to the traffic light charts that most companies use for risk acceptance.
Episode Chapters:
02:00 Interpreting the QMSR and Its Implications
05:56 Impact of QMSR on Risk Management
08:34 Risk Management in Practice
12:09 Insights from FDA Inspections and Warning Letters
23:30 The Importance of Process-Based Approach
24:57 Deep Dive into Risk Policy and Risk Acceptability
26:05 Understanding the Framework of 14971
26:42 The Role of Quality Policy in Risk Management
27:32 Risk Control
29:47 Risk Acceptability in Risk Policy
30:59 Understanding Risk Matrix
32:16 Risk Control and Quality Policy
41:00 Understanding Risk Acceptability Charts
Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.
126 - Combination Products Collaboration, Turnover on MedTech/Pharma Project Teams, and Lessons from working with Intel's CEO with Mat Stratton, Founder of Coalition Ltd
On this episode I was joined by Mat Straton, Founder of Coalition Ltd. In this episode, Mat discusses:
01:02 Venturing into Combination Products
02:46 Andy's Journey into Healthcare Space
04:48 Challenges in Deep Brain Stimulation
08:55 The Impact of working with Andy Grove
10:42 The Struggle with Parkinson's Disease
13:20 The Speed of Product Development
16:09 Collaboration Challenges in Combination Product Space
19:17 The Role of Regulatory Teams
23:12 The Importance of Team Formation and Alignment
33:20 The Vision for Coalition
34:44 Conclusion
Prior to founding COALITION, a collaboration consultancy focussed on speeding progress in highly regulated industries, Mat spent 20 years leading companies within the MedTech and Combination Products spaces. Over this time, Mat developed a formula for success on how to turbo charge collaboration and progress where effective cooperation between multiple disciplines is essential. The key learnings from many successes and plenty of challenges have been distilled in to the approach at the core of COALITION's services and detailed in Mat's upcoming book - "Collaboration - where it's difficult, it's vital."
Email: mat.stratton@coalition.ltd
Website: www.coalition.ltd
Linkedin: https://www.linkedin.com/in/mat-stratton-a6269317/
125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh
On this episode, I do an active reading to begin to unpack the Quality Management System Regulations(QMSR) Final Rule that was issued by FDA in early February 2024.
0:00 Introduction
05:09 Initial Reactions to the idea of the QMSR
06:57 History of the Device cGMP's, QSR, and QMSR
11:52 What's changing in 21 CFR 820?
24:59 What's changing in 21 CFR 4 and Combination Products
33:20 Comments Review and Final Thoughts
Links:
- QMSR Final Rule Amendments: https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments
- QMSR Final Rule FAQ: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked
- 21 CFR 820: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820?toc=1
- 21 CFR 4 (Changes Introduced): https://www.ecfr.gov/compare/2024-02-02/to/2024-02-01/title-21/chapter-I/subchapter-A/part-4/subpart-A
- Device cGMP's 21 CFR 820 (1978): https://archives.federalregister.gov/issue_slice/1978/7/21/31497-31571.pdf#page=12
- Reserved Definition: https://www.archives.gov/federal-register/cfr/about.html#:~:text=An%20agency%20uses%20%22%5BReserved%5D,a%20printing%20or%20computer%20error.
- ANSI View Only Copy of ISO13485 (No Cost): https://ibr.ansi.org/Standards/iso1.aspx
Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.
124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson
On this episode, I was joined by Andy Robertson, founder of CQE Academy.
In this episode, Andy outlines 5 steps to becoming an exceptional quality engineer, such as seeking mentorship, taking on challenging assignments, and being a lifelong learner. Andy stresses the importance of honing soft skills for effective leadership and suggest stepping out of the comfort zone by exploring opportunities outside the quality field. The discussion also highlighted the value of certification courses for professional development. Lastly, they recommend several books for personal and professional growth.
00:01 Introduction and Guest Introduction
04:56 #1: Mentors, Mentors, Mentors: The Importance of Mentorship in Quality Engineering
13:48 #2: The Value of Tough Assignments in Professional Growth
18:44 The Power of Lifelong Learning
19:08 #3: The Importance of Lifelong Learning
20:04 The Struggle of Choosing What to Learn
22:28 Balancing Professional and Personal Learning
23:24 #4: The Underrated Value of Soft Skills
27:43 #5: Leaving Quality
29:21 #6 (Bonus) The Benefits of Professional Certifications
Andy's Website: https://cqeacademy.com/
Youtube: https://www.youtube.com/@CQEAcademy
123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker
On this episode, I was joined by Peter Baker, President @ Live Oak QA.
The conversation revolves around the speaker's experience working with the FDA, starting from his time in San Francisco and culminating in his experiences in international locations like India and China. The discussion outlines the FDA's diverse focus areas, from food to medical devices and clinical trials, and how operational changes in the mid-2010s streamlined FDA's specialized areas. The speaker discusses his inspection methods and how a focus on critical thinking rather than procedural controls leads to more substantial findings, particularly in data integrity within quality control labs across industries. He emphasizes the need for quality-driven, honest investigations in addressing deviations and believes a switch from a compliance-focused mindset to a quality-oriented one should be the future standard.
00:00 Early Career and Diverse Experiences
00:43 Understanding FDA Regulations and Import Work
02:28 Moving Overseas and Program Realignment
07:44 Challenges with Data Integrity
10:33 Understanding the Root Cause of Data Integrity Issues
10:54 The Role of Data Governance and Regulatory Guidance
22:24 Challenges of Field Inspections
24:07 Manipulation of Product Quality
25:26 Jurisdiction and Quality Systems
27:53 Lab Controls and Data Integrity
36:04 Addressing Unknown Discrepancies
39:34 The Importance of Honest Reporting
Peter E. Baker, President, Live Oak Quality Assurance LLC, has been consulting nationally and internationally since 2019. Prior to consulting, Peter spent 11 years as a U.S. FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity and has special interest in big data management and compliance with 21 CFR Part 11.
PIC/S Guidance on Data Integrity: https://picscheme.org/docview/4234
Live Oak: https://www.liveoakqa.com/
Peter's Blog: https://www.liveoakqa.com/blog-1
122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries
On this episode, I was joined by Jim Fries, CEO of Rx360.
On this episode, Jim discusses the critical aspects of audits in medical technology and pharmaceutical sectors. He provides insight into the joint audit program that RX-360 rolled out, its working, and benefits. He addresses the challenges faced, emphasizing the need for relationship building and constant growth via listening and questioning. Lastly, he invites audience feedback to continually improve the show. 00:04 Guest Introduction: Jim Fries 05:45 The Concept and Process for Joint Audits 10:03 Regulatory Compliance and Audit Scoping 15:07 Reevaluation and Frequency of Audits 16:33 Evaluating RX 360's Ability to Conduct Audits 19:13 Understanding the Role of RX 360 in Auditing 19:41 Licensable Audit Reports 20:34 Challenges in the Industry and the Benefits of Joint Auditing 23:31 Addressing the Challenges in Auditing 23:49 The Role of Education in Joint Auditing 25:39 The Impact of RX 360's Working Groups 27:37 The Origin and Evolution of RX 360 29:59 The Importance of Networking and Relationship Building 35:28 How to Connect with Rx360
Jim Fries has touched the healthcare industry for 25 years. For the last 5 plus years he has led Rx-360, a nonprofit industry pharmaceutical consortium, dedicated to supply chain integrity, material quality, and patient safety.
Jim’s background before Rx-360 was geared towards building and leading organizations in the medical device, and diagnostic arena. He has led advisory and guideline committees in the cardiovascular and diabetes arena, authored multiple CPT codes, has also been a delegate to the WHO, and has also led many FDA pathway groups. Jim joins us today as a lifelong advocate of patient safety.
121 - Bench Scientist to Commercial Leader, Amgen in the early days, Challenges in Commercialization, Working in Startups vs. Large Companies, and Silos with Sayed Badrawi
On this episode, I was joined by Sayed Badrawi, Pharma/MedTech Investor and Board Member.
Sayed walks through starting at Amgen as a bench scientist and transitioning to the commercial side of the Pharma industry. Sayed provides advice for people considering their career paths and emphasizes the importance of gaining expertise in a particular area before making significant career changes.
He also highlights some of the challenges and opportunities in the Pharma industry, including the impacts of silos, the complexities of commercialization, and the importance of having a deep understanding of the industry for successful product development and market launch.
00:00 Introduction and Guest Presentation
00:53 Guest's Journey in Medical Device and Pharma Industry
03:10 Transition from Bench Scientist to Business Side
08:31 Commercialization Challenges in Pharmaceutical Industry
13:37 Successes and Failures in the Industry
26:41 Career Advice for Aspiring Professionals: Large vs. Small Companies
32:44 Conclusion
Sayed Badrawi has several decades of business, marketing, and scientific experience in pharmaceutical and biotech companies. He was most recently the CEO of PDS Life Sciences, a global provider of software and services used in preclinical research at top-ten pharma companies. He currently serves on the Board of ISI Life Sciences, a startup focused on diagnostics and therapeutics for use in oncology. He is also providing strategy consulting for several early stage start-ups. Previously, he was the Director and Head of new product commercialization at Mitsubishi Tanabe Pharma America, one of the largest pharma companies headquartered in Japan.
Other experiences include senior pharma marketing positions at Abbott Laboratories and Eli Lilly. Sayed started his career at Amgen as a research associate and was part of the team to first clone and express erythropoietin, one of the first biotech blockbusters. Sayed has an AB degree in microbiology and immunology from the University of California, Berkeley, and an MBA from the University of Chicago’s Booth School of Business.
120 - EU MDR R&R: What's the difference between Legal Manufacturer, Authorized Rep, PRRC, Importer and Distributor? with Founder of Easy Medical Device, Monir El Azzouzi
In this special episode of the comedy podcast, host Subhi Sade welcomes Munir Al Azouzi, the founder of Easy Medical Device.
Munir shares his expertise on the often confusing topic of the EU’s Medical Device Regulation (EUMDR), focusing on the distinctions between roles such as legal manufacturer, distributors, importers, authorized reps, and persons responsible for regulatory compliance.
Munir explains the need for compliance checks, supply chain management, traceability documentation, and regulatory responsibilities in the context of the EUMDR. He also discusses his company's role as an authorized representative, importer, and consultant, and the various services they offer to help medical device manufacturers navigate regulatory complexities.
00:03 Introduction and Guest Introduction
01:47 Understanding the Economic Operator Model
07:56 Legal Manufacturer
09:41 The Role of the Authorized Representative and PRRC
23:39 Understanding the Role and Responsibility of Authorized Representatives
26:14 The Role of Importers and Distributors
27:38 The Importance of Traceability in the Supply Chain
38:14 Terminating a Mandate with a Manufacturer
40:55 Conclusion and Easy Medical Device
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses.
Easymedicaldevice.com
119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens
On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc.
David discusses his broad background, including his roles in quality manufacturing, product development, and technical transfer. He delves into the differences between isolators and RABs—two types of equipment used in clean rooms, critical for sterile processing. David also starts to touch on the standards and parameters set by the EU and ISO, and he suggests various resources, including Annex one and the ISO 14644 standard, for learning more about sterile processing and clean room requirements.
01:01 Experiences in Clean Room
04:23 Exploring Clean Rooms
15:43 Differences Between Isolators and RABs
19:15 Different Types of Isolators
25:53 Understanding the Standards and Guidelines
28:36 How to Learn More About Clean Rooms?
30:13 Conclusion
David Simoens is a certified Project Management Professional with over a decade of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radiopharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. David has led high profile NPI launches for a large pharmaceutical company. Currently, he is supporting a team responsible for delivering a complex formulation system and leading strategy/operations for a midsized consulting company. David can be reached on linkedin here or at David@lifescienceprofessionals.com
**About David Simoens:**
David Simoens is a dedicated Project Management Professional with a proven track record in the pharmaceutical industry. In October 2023, he made the pivotal decision to transition from a C-Suite role at a consulting firm to embark on an entrepreneurial journey. David takes pride in being the founder of Life Science Professionals, LLC; a consulting firm committed to excellence in project management, engineering, and quality within the life sciences sector.
**Key Specializations:**
- Aseptic Fill/Finish including Lyophilization
- New Product Introductions
- Cytotoxic and High Potency Environments
- Integrated Commissioning, Qualification, Validation
- Radiopharmaceuticals
- Business growth and optimization
- Enterprise Quality Management Systems
- Career coaching
**Entrepreneurial Venture: Life Science Professionals**
As the founder of Life Science Professionals, David leverages his extensive executive leadership and hands-on industry expertise to deliver tailored solutions. The firm specializes in guiding clients through the complexities of project management, engineering, and quality.
**Active Involvement in ISPE:**
Beyond his consulting work, David is deeply committed to advancing the industry through active participation in the International Society for Pharmaceutical Engineering (ISPE). Currently, he serves in key leadership roles, including:
- Secretary for the Global Project Management COP
- Secretary for the Great Lakes Chapter
- Steering Committee Member for Digital Validation
- Steering Committee Member for the Special Interest Group on AI and Machine Learning
- Participant in Mentorship Program with Women In Pharma
**Contact Information:**
For all business inquiries, please reach out to David and his team at contact@lifescienceprofessionals.com. For information requests, email them at info@lifescienceprofessionals.com. Feel free to connect and message him on LinkedIn.
118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead
On this episode, I was joined by Douglass(Doug) Mead, Combination Products Expert and Founder of CP Pathways.
Doug presents a thorough walkthrough of drug master files (DMFs) and device master files (MAFs), their types, and their differences. Drawing on his industry experience, he explains advantages, challenges, and practical ways to handle and maintain these files in biopharma companies. Doug provides case examples, discusses trends, future prospects of DMFs and MAFs, and offers advice for companies dealing with aspects of master file content.
Markers:
01:46 Understanding Drug Master Files and Device Master Files
05:11 Doug's Experience with Master Files
07:43 Challenges and Advantages of Using Master Files
11:33 The Role of Device Master Files
12:44 Overlap Between DMFs and MAFs
31:14 The Future of Master Files
Douglass(Doug) Mead is Founder of CP Pathways. He's a highly experienced combination products regulatory expert with more than 40 years of experience in large and small pharma and medical device companies. He has a diverse background in regulatory affairs for drugs and devices, including their design and testing, risk analysis, human factors testing, stability testing, and clinical trial real use patient handling assessments.
117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano
On this episode, I was joined by Khaudeja Bano, VP of Quality for Combination Products at Amgen.
In this episode, the we discuss the details related to post-market safety reporting for combination products. The conversation extends to the comparison connecting safety and quality, the importance of cross-functional teams for risk management, and the approach towards health hazard assessments. Additionally, they delve into managing product responsibilities, the varied international reporting requirements, and the use of technology for improved efficiency.
00:54 Post-Market Safety Reporting
05:23 Challenges in Post-Market Safety Reporting
07:57 Reporting Databases
10:05 21 CFR Part 4b Guidance
11:50 Managing Product Responsibilities
19:12 Challenges in Handling Platforms
23:10 Understanding Health Hazard Assessment
25:32 International Approach to Reporting
Dr. Khaudeja Bano is the VP of Combination Products Quality at Amgen. Executive director of combination product safety. She's held multiple roles at other companies as well like Abbvie, Abbott, and Guidant and is the chair of the Post Market Safety committee for the combination products coalition.
116 - Gas Sterilization, ETO, Pre-Conditioning, Materials, Different Gases, Bioburden, Validation, and Safety with Jeanne Moldenhauer
In this episode, I was joined by Jeanne Moldenhauer, a sterilization expert to discuss all things gas sterilization.
Jeanne and I explore how efficiency is determined by the seal of the container and the type of material being sterilized. Jeanne discusses its application in medical devices, the challenge of permeability, and its comparative cost-effectiveness. Jeanne delves into how the sterilization process works, safety considerations, validation, and the use of gas sterilization in combination products. Lastly, Jeanne discuss sterilization process development and the challenges that come with gas sterilization.
00:23 Deep Dive into Gas Sterilization
00:46 Applications and Limitations of Gas Sterilization
01:51 Understanding Material Permeability in Gas Sterilization
02:29 Gas Sterilization in Medical Devices
06:15 Different Types of Gases Used in Sterilization
07:41 Safety and Environmental Risks of Gas Sterilization
14:14 Understanding the Gas Sterilization Process
18:25 Safety Measures in Handling Gas Sterilization
25:39 Validation and Bioburden Considerations in Gas Sterilization
35:28 Gas Sterilization in Combination Products
Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.
115 - Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban
On this episode, I was joined by Katherine Eban, the New York Times best-selling author of "Bottle of Lies".
In this episode, Katherine dives deep into her decade-long investigation into the quality issues prevalent in generic drug manufacturing overseas. Eban highlights the need for improving transparency in the pharmaceutical industry. She shares some inspiring stories of dedicated professionals in the industry who strive to ensure patients receive quality. Eban also discusses her findings on fraudulent practices in manufacturing plants and the role of quality data in drug production. The episode sheds light on the importance of understanding the manufacturing process behind generic drugs and critical quality control issues needing urgent attention.
Time-Stamps:
02:12 The Start of the Investigation into Generic Drug Quality
08:59 The Impact of Quality Issues on Global Health
12:54 Understanding the FDA's Role in Drug Quality Control
16:55 The Struggle to Maintain Quality in the Pharmaceutical Industry
18:39 The Ranbaxy Story
27:45 Peter Baker
30:19 Quality Stories
33:27 Conclusion and Final Thoughts
Link to Katherine's Book: Bottle of Lies: The Inside Story of the Generic Drug Boom, is a New York Times bestseller and one of the New York Times’ 100 Notable Books of 2019.
114 - Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, and Combination Products with Jeanne Moldenhauer
On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting.
Jeanne talks through the different methods of irradiation like gamma, beta, microwave, x-ray, and ebeam, their respective pros and cons, as well as their environmental impacts. Jeanne also delves into the practical considerations associated with this sterilization method.
This includes important factors like product density, cycle development, dosimeters, sterilization and the bioburden. The episode ends with a look at the regulatory approval process, addressing the timeline for validating an irradiation sterilization cycle.
00:22 Understanding Irradiation Sterilization
00:34 Differences between Autoclaving and Irradiation
04:22 The Impact of Product Density on Irradiation
05:09 The Role of Dose in Irradiation Sterilization
06:21 E-beam Sterilization
08:52 Impact of Gamma Sterilization on Different Materials
22:07 The Role of Bioburden in Irradiation Sterilization
30:19 Dosimetric Release
37:31 Gamma Irradiation for Combination Products
41:59 The Process of Validating an Irradiation Sterilization Cycle
Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.
113 - Pharma/MedTech Market, Why Good People Leave, Finding Motivation, Onshoring in Pharma and Motivation with Ira Mann
On this episode, I was joined by Ira Mann, President at IQ Referrals. Ira and I discuss:
- Pharma/MedTech Market and Positioning for Success
- Why people leave good companies
- Finding Motivation in Pharma/Quality
- Remote Work, Insourcing, On-Shoring in US Manufacturing
Ira Mann is President, IQ Referrals. With more than 20 years in the recruiting industry, Ira is an expert at placing top professionals in the Quality, Validation, Regulatory Affairs, Cold Chain, Environmental Monitoring and Sterilization specialties, and is strategically aligned with experts conducting searches in Engineering, R&D and Manufacturing Management.
112 - Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer
On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne and I discuss: -Steam Sterilization - Moist and Dry Heat -Biological/Chemical Indicators, Placement and Resistance -Cycle Development and Validation -Overkill Cycles vs Product Specific Cycles -Parametric Release of Steam Sterilized Products
Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.
111 - 7 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi Saadeh
On this solo episode, I go through a list of 7 books I recommend for med tech, biotech and combination product professionals.
The books are:
- Quality is Free by Phillip Crosby
- The Combination Products Handbook by Susan Needle
- What Country has the Best Healthcare by Ezekiel Emanuel
- Switch by Dan and Chip Heath
- Managing Oneself by Peter Drucker
- Bottle of Lies by Katherine Evan
- The Pyramid Principle by Barbara Minto
I find that I read a lot more in December so wanted to give you all some recommendations this Thanksgiving week. Happy Thanksgiving!
110 - CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfer, Trust and Fashionisity with Ben Locwin
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss:
- Dealing with CDMO's and CXO's
- Supply Chain and Logistics and Pharma and Medical Devices
- Reverse Knowledge Transfer
- Building Trust with CXO's and Leveraging Surveys
- The future of the CDMO Market
Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.
109 - Protecting Patients at All Costs, Being a CQO in Big Pharma, Supply Chain Security and Generic Drugs with Martin Van Trieste
On this episode, I was joined by Martin Van Trieste, Author of Protecting the Patient at All Costs: The Drug Watch Dogs and is the Former Chief Quality Officer at Amgen and Former CEO at Civica Rx.
Martin and I discuss:
- Protecting the Patient at All Costs
- Quality Leadership and being a Chief Quality Officer in Big Pharma
- Supply Chain Security
- Generic Drugs and Shortages
Martin Van Trieste is an accomplished entrepreneur, board governance expert, executive coach and biopharmaceutical executive. Martin Van Trieste is the Former President and CEO of Civica Rx.
Prior to joining Civica Rx, he worked with Amgen, a leading biotechnology company and also previously served as vice president of worldwide quality for Bayer Healthcare’s Biological Products Division and vice president of quality assurance for the Hospital Products Division for Abbott Laboratories.
Van Trieste has also taken on ventures of his own. He’s the founder of Rx-360, an international nonprofit organization that enhances patient safety by increasing security and quality in the biopharmaceutical supply chain.
He has also served as the chairman of the Parenteral Drug Association (PDA) Board of Directors and was honored with the 2020 Joseph B. Sprowls Lecturer award.
108 - Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins
On this episode I was joined by Margaret Jenkins, who's the Founder and Principal at Global Pharma Solutions. Margaret and I discuss:
- Clinical Data interpretation and authoring
- eCTD Module 2 Overview
- Learning drug assays with a device background
- Non-Clinical eCTD Module 4
- Clinical eCTD Module 5
Margaret Jenkins is the Founder and Principal at Global Pharma Solutions where she works closely with clients to provide strategic solutions, allowing them to follow the most efficient pathway to registration and launch in their chosen markets. Margaret has more than 30 years’ experience in the Pharmaceutical industry both in the UK and Australia, spanning drug discovery, drug development and Regulatory Affairs.
Margaret has hands-on experience in numerous successful global submissions in both the innovator and generic spaces for: US, EU, Asia Pacific and ANZ. Margaret has written all 5 modules of the CTD including writing clinical overviews and summaries, several module 3s (CMC), and summarizing pre-clinical reports.
107 - Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu
- Pre-Trained Models and Generative AI
- Distilling Decades of MedTech Data/Historical Data Review
- Adopting new technologies in Quality and Regulatory Affairs
- Removing the tribal knowledge barrier
Michelle Wu is the Founder and CEO of NyquistData Inc. Michelle has over seven years of experience in strategic planning, business development, and global strategy. Prior to NyquistData, Michelle was the Founder of Anora.ai, a company that provides artificial intelligence services. Michelle has also worked as a Co-Founder at Waveall Inc., where they helped connect people with common interests through mealtime. Michelle began their career as an Analyst at The Boston Consulting Group. Michelle holds a bachelor's degree in economics from Harvard University.
Michelle Wu pursued a Master of Business Administration (M.B.A.) at Stanford University Graduate School of Business with a focus in healthcare and investment. Prior to that, they completed a Bachelor's degree in Foreign Languages and Literatures, General from Peking University.
106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott
On this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them!
If you'd like to hear more about Michelle checkout episode 031, 077, checkout Michelle's Blog @ LeanRAQA.com and Michelle's Podcast RAQA Today.
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries.
Links: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2024fy2024
https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-statement-fda-continues-take-steps-strengthen-premarket-notification-510k-program
106 - Temperature Mapping, Validation, Data Loggers, Cold Chain, Monitoring and Commissioning with Nathan Roman
On this episode, I was joined by Nathan Roman, an expert in temperature mapping and environmental validation. On this episode, Nathan and I discuss:
- Temperature Mapping and Monitoring
- Validation and Commissioning
- Changes in Data Logger Technology
- Cold Chain vs. Ambient
Nathan Roman is a highly accomplished expert in equipment commissioning, qualification, and validation, with over 23 years of hands-on experience in the Health & Life Science industry. In his current role, he successfully manages a team of experts, develops business strategies, and oversees the growth of his practice, all while delivering exceptional services to a diverse portfolio of clients.With expertise in cGMP compliant facilities, R&D labs, and temperature mapping, Nathan ensures regulatory compliance. He excels in placing temperature sensors in control chambers, streamlining processes for faster delivery. Nathan aids professionals in achieving compliance, providing training, collaborating with vendors, and offering temperature mapping guidance. An industry thought leader, he empowers clients with mapping knowledge, sensor placement strategies, and equipment qualification expertise.
105 - Triathlon: The Combination Products of Sport, 8 Lessons from Ironman Chatanooga and 100 Episodes with Subhi Saadeh
On this episode, I reflect on 8 lessons I learned from recording 100 Episodes of the Combinate Podcast and Ironman Chatanooga.
Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.
For feedback on the show or suggestions please contact subhi@letscombinate.com
104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew
On this episode, I was joined by Sara Waxberg MacNew, Chief Scientific Officer at Design Sciences. On this episode Sara and I discuss:
- New FDA Guidance:
- Critical Task Definition for Combination Products
- Pre-Clinical HF Studies in readiness for IND Submission
- URRA
- Human Factors Validation vs. Design Validation
Sara Waxberg McNew is the Chief Scientific Officer at Design Science, a human factors firm that specializes in healthcare. Sara has held roles previously in user centered design leadership at Eli Lilly, Philips Healthcare, and Baxter Healthcare. She is an active member of AAMI where she has contributed to the development and revision of human factors technical information reports and international standards. Learn more about Design Science's impact on Healthcare Technology by following @designscience on all social media platforms.
103 - Prescription Reconciliation, Medication Error Reduction, Automated Home Care, Assisted Robotics, Patient Behavioral Monitoring, and the future of Clinical Trials with Charles Gellman
102 - Human Error, Doing Quality Differently, Defining Accountability, Written Human Guidance, Blue Line vs. Black Line and Categorizing Deviations with Amy Wilson and Cliff Berry
On this episode, I was joined by Amy Wilson and Cliff Berry, authors of "Do Quality Differently: The Playbook for Creating More Success in Biopharma (or Any) Manufacturing".
Amy and Cliff walkthrough:
- Human Performance and Challenges
- Defining Accountability from a Quality World-View
- Good Written Human Guidance
- Automating Procedure and QMS Feedback
- Categorizing Deviations Appropriately
- Blue Line vs. Black Line: Work as Imagined vs. Work as Completed
Amy Wilson: Amy has more than 20 years of biopharma manufacturing experience, focusing on human & organizational performance, operational excellence, risk management and technical training. She has led a global integration of Human & Organizational Performance within biopharma manufacturing. Amy has a Ph.D. in Industrial Engineering from North Carolina State University.
Cliff Berry: Cliff has worked in the domain of Human & Organizational Performance for over 20 years. He has experience in commercial nuclear electric generation, electric transmission & distribution, gas distribution, nuclear plant systems controls hardware & software integration, and most recently in biopharma manufacturing since 2015 where his primary focus is on creating more quality success. Cliff has a M.S. in Occupational Ergonomics & Safety from the University of Massachusetts Lowell.
101 - Micro-Array Patches, Combination Products in Australia, Differences between TGA and RoW, Novel Delivery Systems, and Clinical Trials with Megan Polidano
On this episode, I was joined by Megan Polidano, Head of Clinical and Regulatory affairs at Vaxxas.
Megan walks through:
- Micro-Array Patches and Needle Free Injections
- EPAR's and AusPAR's
- Combination Products in Australia
- Clinical Trials in Australia
- Australia Regulatory Pathways - Core A and Core B
Megan Polidano is the Head of Clinical and Regulatory affairs at Vaxxas. Megan has worked in regulatory affairs since 2007 and have worked for large pharmaceutical and medical device companies as well as small biotechnology companies in Australia and in the US.
100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager
On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through:
- Episode 100 and the first recording with Larry!
- Quality - Big Q/little q
- Building a QMS and Commercializing a product at a startup
- Predictive Quality Management, PDCA and TOC
- Lessons from Pharma, Combination Products, and CRO Companies
- Communicating quality
Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at larry@mgmt-ctrl.com
099 - Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson
On this episode, I was joined by Janine Jamieson, European Editor at International Pharmaceutical Quality. In this episode, Janine walks through: -Medical Device vs. Medicinal Product Reviews in the EU -Working at MHRA as a Pre-Market Reviewer on Devices with an Ancillary Medicinal Substance -Notified Bodies, EU MDR and Article 117 -European Commission, Member States and European Member States Structure -Writing about combination products in the EU Janine is European Editor at IPQ (International Pharmaceutical Quality) Publications, living in Sweden and writing about the regulatory dialogue at biopharma conferences. She writes about quality/CMC issues, innovation and reliance, and drug-device combination products. Between 1997 and 2016, Janine was a pharmaceutical assessor at the UK MHRA, where she focused on device-drug combination products, working with several EU notified bodies, and with MHRA colleagues on drug-device combination products and borderline classification issues. She helped with training, set up a cross-agency combination product working group, and was involved in horizon scanning and innovation office activities at MHRA and EMA. She has also been an enthusiastic contributor to TOPRA, The Organization for Professionals in Regulatory Affairs, from special interest networks to training and chairing conference sessions.
098 - MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi
On this episode I was joined by Bijan Elahi, Award winning Medical Device Risk Management author, educator and consultant.
Bijan walks through:
- MedTech vs. Aerospace - Differences in Risk Management Approaches
- Risk Control/Reduction - AFAP vs. ALARP or ALARA and Global Requirements
- Quantifying Benefit and Benefit/Risk
- Risk Control Measures
- What a good risk management process looks
Bijan Elahi has worked in risk management for medical devices for over 29 years at the largest medical device companies in the world, as well as small startups. He is a Technical Fellow, and the Medtronic corporate Advisor on safety risk management of medical devices. In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide. Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he is also teaching a graduate course on medical device risk management at Drexel University (Philadelphia, USA).
Contact: You can contact Bijan at his website: https://www.medtechsafety.com
097 - Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager
On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through:
- Predictive Quality Management and PDCA
- Business Process Capabilities and process stewardship
- 3 Lines of Quality Defense
- COSO Risk Management
Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at larry@mgmt-ctrl.com
096 - Pharma Waste Management, Sustainability, What Happens to Sharps, Disposal and Zero Waste with Heather Johnson
On this episode I was joined by Heather Johnson who's the CEO of Ingenium.
In this episode, expect to learn:
• Why Waste Management in Pharma might be more complicated than you might think
• Different kinds of sharps, why sharps are challenging and what happens to sharps containers?
• Waste potential and repurposing orphan chemicals
• And what Zero Waste means for sustainability
Heather Johnson has over 25 years of expertise in the hazardous waste management industry as a C-level Executive, Sales/Marketing Director and Account Manager. As a seasoned entrepreneur who has launched several existing waste management firms, Heather is a founding partner of INGENIUM and currently serves as its Chief Executive Officer.
Heather’s innovative vision into sustainability for regulated waste management has positioned INGENIUM as an industry leader in innovative waste to energy programs and has provided INGENIUM’s clients with environmentally friendly alternatives to waste disposal, including zero waste initiatives. Heather is well known for her participation in the industry, including her past presidency of BioNet, a non-profit association devoted to biological safety. She has also served on the Board of Directors for several local non-profit organizations and has made community service a priority for INGENIUM and its employees.
095 - How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN's, pFMEA's and making it simpler with Naveen Agarwal
- How FMEA's fit into ISO14971
- pFMEA's from External Partners and linking to risk files
- Simplifying Risk Management outputs for Audit
Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.
Show Notes and Links:
Let’s Talk Risk Newsletter: naveenagarwalphd.substack.com
Naveen’s Video on “When FDA Disagrees with your risk calculation method”: youtu.be/Y14_RTHMGqw
Warning Letter 1: www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medtronic-inc-617539-12092021
Warning Letter 2: www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/irhythm-technologies-inc-643474-05252023
M
094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young
On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD).
Rumi walks through:
- Connected Devices and Combination Products
- How Regulators approach regulating new technologies
- Traceability Technologies and what they mean for manufacturing and use
- Comparability Protocols and Pre-Determined Change Controls for Drugs and Devices
Rumi Young, Meng, RAC is the Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a team that advances policies to speed time to market, promote innovation and ensure reasonable regulatory requirements for medical devices, diagnostics and combination products. Rumi joined BD from FDA where she spent four years in CDRH’s Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.
093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle
On this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss:
- Supplier Management for Combination Products
- Drug & Device Analytical Testing
- Considerations for Biologics
- Connected/Digital Health
- Changing Regulatory Landscape for Combination Products
Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press.
Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Award Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development. Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, providing international quality, regulatory affairs, and design excellence services, to the biopharma, biotech, and medical device industries.
She continues to fulfill her passion in this space as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International and AAMI standards committees. Susan teaches curricula in Combination Products through UMBC, AAMI, and DIA, as well as customized training upon request. She is also active in multiple industry working groups including CPC, AFDO/RAPS, DIA, TOPRA and PQRI, and enjoys speaking at a variety of industry forums.
092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder
• Distinguishing differences in framework between the Device QSR/QMS and Drug cGMP’s
• Learnings from Training FDA CDER and CBER on device requirements
• Lessons from being Head of QA at a manufacturing site and internal audit
• Teaching through AAMI and his YouTube channel: Quality Systems Explained
Aaron Snyder is a quality management systems expert and is currently VP of QA at Allotex. Prior to joining Allotex, Aaron served in roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. He has worked with a wide range of pharmaceuticals, medical devices and combination products.
Aaron is a member of the AAMI Faculty and teaches several courses focused on various QMS topics. Aaron is also and avid content creator and dissects, presents and teaches on QMS and cGMP’s topics on his YouTube channel: Quality Systems Explained.
091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle
On this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss:
- Part 1 of The Combination Products Handbook: A Practical Guide to Combination Products and Other Combined Use Systems: Foundation
- Subhi's questions on each chapter
- What she learned from authoring and coordinating of the book
Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press.
Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Award Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development. Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, providing international quality, regulatory affairs, and design excellence services, to the biopharma, biotech, and medical device industries.
She continues to fulfill her passion in this space as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International and AAMI standards committees. Susan teaches curricula in Combination Products through UMBC, AAMI, and DIA, as well as customized training upon request. She is also active in multiple industry working groups including CPC, AFDO/RAPS, DIA, TOPRA and PQRI, and enjoys speaking at a variety of industry forums. Susan can be reached at sneadle@combinationprod.com.
090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar
On This Episode, I was joined by Harsh Thakkar, CEO of Qualtivate. Harsh walks through:
- Automating Quality with No Code Tools
- Software Validation
- Infrastructure Software
- Out of the Box
- Configured Software
- Custom Software Systems
Harsh Thakkar is the CEO and founder of Qualtivate, a data-driven quality management consulting firm for life sciences. He is an industry veteran who has spent more than a decade in quality assurance and regulatory compliance roles with companies like Takeda, Biogen, Merck, Johnson & Johnson, and Bristol Myers Squibb. He is an American Society of Quality (ASQ) Certified Quality Auditor and Certified Manager of Quality/Organizational Excellence.
Show References:
McKinsey article: https://www.mckinsey.com/industries/life-sciences/our-insights/smart-quality-reimagining-the-way-quality-works
FDA CSA guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software
Naval Ravikant's book: https://www.navalmanack.com/
089 - Talking HealthTech Podcast, Consistency, Australian Innovation in HealthTech, Content, and Community with Peter Birch
On this episode, I was joined by Peter Birch, CEO and Host of Talking HealthTech. Peter walks through:
- Talking HealthTech Podcast with 350+ Episodes - HealthTech Innovation in Australia
- Audience building - Peter/TH's Creative Process for Podcasting (2/3/4 episodes per week)
Peter Birch is Founder and CEO of Talking HealthTech - a podcast and membership community to learn and connect about technology in healthcare. In addition, Pete is a director of the Medical Software Industry Association (MSIA) who are the voice of healthcare software vendors in Australia, and also director of MetaOptima Technology who are helping clinicians diagnose skin cancer using artificial intelligence. He is also on the NSW State Committee for the Australasia Institute of Digital Health, and is a NSW State Facilitator for the Australian Clinical Entrepreneurs Program (AUSCEP). He holds a Master of Business Administration (MBA), is a Certified Health Informatician (CHIA), and also a Certified Practicing Accountant (CPA).
088 - Production Part Approval Process(PPAP) with Subhi Saadeh
On this episode, I outline an introduction to one of my favorite APQP tools, Production Part Approval Process(PPAP):
- What is PPAP
- Inputs, Process, Triggers and Interactions
- PPAP Elements and Tools
- The difference between first article inspection(FAI) and Capability Studies
- Applications and Challenges in use
Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.
For feedback on the show or suggestions please contact subhi@letscombinate.com
087 - From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque
• Landing in Medical Devices and Pharma Regulatory Affairs
• Rules of engagement
• On the record, Off the record, On Background
• Danny's Process in writing, editing and publishing
Ferdous Al-Faruque, known as Danny, is Senior Editor at RAPS and specializes in reporting on regulatory affairs, new medical device technologies such as mobile health, combination products, unique device identifiers, and issues surrounding interoperability and cyber security.
086 - Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with Fran DeGrazio
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions.
Fran and I discuss:
(0:00) Component Machinability
(3:47) Stopper/Plunger Coating vs Lamination
(13:22) Stopper/Plunger Manufacturing
(26:14) USP 381/382
Fran DeGrazio is President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Officer at West Pharmaceuticals.She has been in the pharmaceutical packaging industry for over 35 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, pre-fillable syringe systems, and injectable combination products.
Throughout her tenure at West, DeGrazio has served in various functions within the analytical laboratory, research and development, and quality assurance/regulatory areas.DeGrazio is an active member of the PDA PMF Visible Particulate Task Force leadership team and the IPAC-RS Materials Working Group. She has also received the Healthcare Business Woman’s Association Luminary Award for West Pharmaceutical Services in 2017 and the Philadelphia Business Journal Healthcare Innovators Award in 2018.