The Qualitalks Podcast

In this episode of the Qualitalks Podcast, we are honoured to have Toon Lambrechts as our guest. Toon is a self-proclaimed biotech nerd with an impressive background in the field of advanced cell and gene therapies. In this episode, we’ll dive into Toon’s passion for democratizing access to these life-changing therapies and explore his work as a co-founder of MyCellHub, a SaaS solution for biomanufacturing. We’ll also discuss the current state of data management and documentation practices in GMP environments and the challenges they pose for the industry. Plus, we will explore how MyCellHub’s toolkit is revolutionizing the biomanufacturing process by improving quality compliance and production times. Finally, we’ll shift gears towards Toon’s thoughts on the ever-evolving pharma industry amidst global events such as COVID-19. How will digitalization and data integration play a role in shaping the future of pharmaceuticals?

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You can watch the video episode here. Learn more about GMP by joining our free educational webinars at www.qualistery.com.

This episode is Sponsored by Eupry, a provider of state-of-the-art environmental monitoring systems. Eupry supports the further development of a host of industries, including Laboratory, Pharmacy, Healthcare, Pharma, Food, and more, by providing efficient solutions to monitor temperature-sensitive assets.

Join us on our webinars and visit our website for more GMP insights, tips, and resources. Don't miss out - follow Qualistery today!

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

This episode is Sponsored by Eupry, a provider of state-of-the-art environmental monitoring systems. Eupry supports the further development of a host of industries, including Laboratory, Pharmacy, Healthcare, Pharma, Food, and more, by providing efficient solutions to monitor temperature-sensitive assets.

Join us on our webinars and visit our website for more GMP insights, tips, and resources. Don't miss out - follow Qualistery today!

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

Steve Galen has been involved in clinical trials for more than 27 years now, in various high-level positions. In this podcast episode, he will explain the different stages of the clinical trials and point out the most severe deficiencies in the industry and how to overcome there.

By listening to this episode of watching it, you will learn about:

• What is a clinical trial, and what's the main goal?
• What are the questions asked in clinical trials protocols?
• What are the parts of a clinical trial?
• How are those parts connected to the primary goal?
• What are the most common challenges with clinical trials nowadays?
• How can we make clinical trials more transparent and predictable?
• What are the goals of VC-funded biotech in early-stage clinical development versus pharma in later-stage clinical development, and how are these goals related to the primary purpose of a clinical trial?

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Watch or read the full podcast and read the article at https://podcast.qualistery.com/what-are-clinical-trials-and-and-how-to-solve-its-biggest-challenges

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This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast episode, our guest is Chris Maughan, a Sterilisation and Validation Consultant. 

Chris has spanned over 16 years with areas of expertise including validation compliance and consultancy support and training across Europe, the Middle East, Asia and the USA.

In this episode, you will learn about:

• What is the role of autoclave sterilization in the pharmaceutical industry?
  • What are some of the significant types of autoclaves in the market?
  • How to choose an autoclave for your needs?
  • How would you go about choosing a good vendor for autoclaves?
  • What should go in the URA for autoclaves?
  • What to check through all the qualification steps?
  • What routine tests should you run on autoclaves daily?

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Watch or read the full podcast and read the article at https://podcast.qualistery.com/how-to-choose-and-qualify-autoclaves-and-what-pitfalls-to-avoid

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This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast episode, our guest is Philippe Tschopp. Philippe is a Business Developer at Glatt Pharma and an enormous Excipient enthusiast.

Because of his passion, he found the website www.pharmaexcipients.com, where they post scientific insights about developments in the excipient world.

In this episode, Yan Kugel interviewed Philippe about the ever-changing excipient landscape and its role in drug manufacturing.

Listing to the podcast, or watching the video, among others, you will learn about:

• What makes excipients such an exciting field
• How pharmaexcipients.com was born, and what is its purpose?
• Where is the excipient market heading?
• What should change in the excipient world?
• What can be achieved by choosing the most optimal excipient for the novel drug?

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Watch or Listen to the full podcast and read the article at https://podcast.qualistery.com/how-is-the-excipient-world-evolving

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This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast episode, our guest is Troy Fugate, a pharma industry and GMP veteran with 30+ years of experience in the field. Now, he is the Vice President at Compliance Insight, Inc. They help businesses overseen by the FDA navigate the regulatory process, achieve compliance, and develop best practices for manufacturing innovative drugs, medical devices, and biologics.

Troy believes that the single most challenging issue leaders face is incorporating GMPs into their company culture. The leaders don't know how to blend GMPs into their mission and vision with the right passion. Only then can employees see the whole vision and understand the "Why". Not just to do things because "it's required by the GMPs" but to see the value in those actions.

Listening to the podcast or watching the clip, you will learn:

• How to establish a unified quality mission across a pharma organization
• Why some people see GxP as a hurdle, and how to change that
• Why using KPIs wrong can cost you your best employees
• How to Deliver Effective and Measurable GMP training

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Watch or read the full podcast and read the article at https://podcast.qualistery.com/infusing-gxps-into-your-organizations-dna

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This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast episode, our guest is Marc García Gómez, a pharmaceutical contamination control strategy consultant. He is also the author of various articles in Spanish pharmaceutical magazines about cleaning and disinfection. During their talk, Marc discussed with Yan Kugel about the EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products draft and how it would affect pharma companies and their current contamination strategies.

Here are some of the things you'll learn about listening to or watching the podcast:

· A new dawn for microbiologists in the pharmaceutical industry

· What critical ideas Annex one introduces

· What new roles will the Maintenance department, upper management, and operators will have

· The importance of validating aseptic agents

· How to start preparing for the Annex 1 launch

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Watch or read the full podcast and read the article at https://podcast.qualistery.com/how-will-the-revised-annex-1-impact-your-contamination-control-strategy

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This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, Yan Kugel and our guest Jerry Chapman talk about how the landscape has changed over the years in the Pharma industry and what things have remained the same. In this episode, they discuss technological advancement in the pharmaceutical industry, what holds us back, and where we are headed.

Who is Jerry Chapman?

Currently working as Senior GMP Quality Expert at Redica Systems, Jerry has invaluable experience in the quality domain and implementation of international GMP regulations in quality policies. With experience spanning 40 years, he is helping to develop coursework on manufacturing deviation investigations and teaching the course to enable the personnel to conduct and properly document investigations.

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Watch or read the full podcast and read the article at https://podcast.qualistery.com/why-we-need-new-technology-in-gmp-and-what-stops-us

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This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, our guest is Jerry Chapman, a GMP expert with more than 40 years in the industry. Jerry and Yan talk about what has changed in pharma over the years and what has remained the same. He discusses the development of new courses as well as the importance of leadership training in the companies.

Who is Jerry Chapman?

Jerry Chapman is Senior GMP Quality Expert at Redica Systems. He brings over 40 years of experience in the pharma industry, including 31 years at Eli Lilly, where he worked in product development, biosynthetic human insulin manufacturing, and site and corporate quality. At Redica Systems, Jerry works with the machine learning and data science teams. They build computer models that examine enforcement actions and produce analyses the way an expert would in the past using hard copy documents and a highlighter. He is also an author of many articles detailing and analyzing current hot topics among the pharma industry, and international regulators appear on the Redica Systems Conference Spotlight page.

Listening to the podcast, you will learn about:

● The Evolution of Pharma Industry

● FDA Training Requirements

● Required Skills in Quality Domain

● Why Generalists are a Bad Thing

● Better Methods for Training Experts and Leaders

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Watch or read the full podcast and read the article at www.podcast.qualistery.com/things-that-have-to-change-in-gmp-to-drive-success
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This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, Yan Kugel and our guest Megann Löffler talk about the new trends in the pharmaceutical industry, what you need to know about the market and what the companies are looking for. Her experience in the recruitment field enables her to give valuable insights that will potentially help you to build a successful career in the future.

Who Is Megan Löffler?

With an educational background in engineering coupled with an HR degree, Megann is currently working as a Talent Acquisition Manager at Headcount AG. It is a Zürich based consultancy serving clients in the pharmaceutical and biotechnology market segments. Megan has been working as a recruiter for six years, specializing in Pharma since the very start of her career. She is now building up her team within headcount and embracing management responsibilities and technical operations positions.

Listening to the Podcast, You Will Learn About:

● Innovations in the Pharmaceutical Industry

● Effect of New Developments on Recruiting Process

● Challenges for the New People in the Industry

● What Are Pharmaceutical Companies Looking for?

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Watch or read the full podcast and read the article at www.podcast.qualistery.com/how-to-build-a-successful-career-in-the-pharma-of-tomorrow

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This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, Luis Charles Chavarría shares his invaluable insights from his 30-year career in the FDA. He explains how the FDA really operates, their main purpose during an audit, and sheds light on details you have probably never known about the FDA. 

Who Is Luis Charles Chavarría?

Luis has served in FDA for about three decades in several capacities that have earned him an unprecedented understanding of FDA affairs. He is currently working as President/Lead Consultant at Supaso International. He has also worked with the US Department of Justice and contributed to policymaking at the national as well as on the international level.

Reading the Article and Listening to the Podcast, You Will Learn About:

● What Does an FDA Agent Do?

● Difference Between an FDA Investigator and a Regular Quality Auditor

● Evidence Development by an FDA Investigator

● Procedures for Foreign-Based Manufacturing Units

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Watch or read the full podcast and read the article at www.podcast.qualistery.com/guide-to-preparing-yourself-for-an-fda-audit/

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This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, we have with us Yan Leyfman, MD. We will discuss and ask Dr. Leyfman about his views regarding how medicine and medical research will look in the future and the role of Artificial Intelligence and Personalized Medicine in disease treatment and the future of medicine. We will also ask Dr. Leyfman about some of his extraordinary career and life experiences.

Who Is Yan Leyfman?

Yan Leyfman, MD, is a medical doctor and a passionate researcher. His areas of command and interest are immunology, and oncology, i.e., the study of cancer. He is a survivor of the Chernobyl Nuclear Disaster in the USSR, and this incident deeply connects with his career and life ambitions.

Listening to the podcast, you will learn about:

● Dr. Leyfman's Career Inspiration and His Services in COVID-19 Pandemic

● What Factors Hinder Progress in Medical Research?

● Role of Artificial Intelligence (AI) in the Future of Medicine

● What Does the Future of Personalized Medicine Look Like?

● What Could Be the Next Breakthrough in Medicine?

● COVID-19 Pandemic for the Future of Medicine

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Learn More About GMP at www.qualistery.com.

Watch or read the full podcast and read the article at www.podcast.qualistery.com/how-does-the-future-of-medicine-look-like/

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This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

Our highly experienced and knowledgeable guest for this session is Kurt in Albon.

Kurt is Global Head of Information Quality at Lonza, one of the biggest CMOs in the world. He has been in the pharmaceutical industry for more than 25 years and holds leading-edge expertise in data integrity, pharmaceutical validation, international team management, and computer science.

For this special episode, co-hosting alongside Yan Kugel is Ammar Badwy. Ammar is CEO and co-founder at Pharmaoffer, an online business-to-business platform for pharmaceutical ingredients.

In this podcast, you will learn:

● What are CMOs or CDMOs and what do they do?

● History of CMOs - How long have they been there?

● How to find the right CMO/CDMO?

● How does a contract manufacturing organization earn?

● What is the future of contract manufacturing?

● Some more interesting information about CMOs/CDMOs

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Learn More About GMP at www.qualistery.com.

Watch or read the full podcast and read the article at podcast.qualistery.com.

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This episode is Sponsored by Dot Compliance, the industry’s first ready to use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, Yan Kugel and our guest Rizgar Saltik talk about networking, branding, and marketing using LinkedIn, arguably the best online platform for professionals and business interactions. They also discuss using LinkedIn marketing to grow a robust business network as a pharma company, business, or independent entity.

Who Is Rizgar Saltik?

Currently working as a partner and consultant at Sciential, Rizgar is life sciences and health entrepreneur specializing in Digital Marketing and Consultancy. He has an educational background in Neurobiology and Business Management. Rizgar has been behind the success of more than 25 medical technology and biotechnology-related product launches and their commercialization.

In This Blog Post, You Will Learn:

● Why Are More People Using LinkedIn Now?

● How to Use LinkedIn for Networking?

● How to Use LinkedIn for Personal Branding?

● How to Use LinkedIn Marketing for Growing Your Business?

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Watch or read the full podcast and read the article at https://podcast.qualistery.com/how-to-use-linkedin-marketing-to-grow-a-powerful-business-network/

Ask questions and learn about GMP here: www.qualistery.com.

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This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier. Learn more about them here: https://is.gd/l8BTWt

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast with Kurt In Albon, we will look at the concept of true leadership and its importance in the pharmaceutical industry. Kurt will tell us what essential qualities are required to be a successful leader, what pharma companies should look for when hiring talent, and some valuable tips for people who aspire leadership.

Kurt is Global Head of Information Quality at Lonza, one of the biggest CMOs in the world. He has been in the pharmaceutical industry for over 25 years and holds leading-edge expertise in data integrity, pharmaceutical validation, international team management, and computer science.

● What Is Leadership and Why Is It Important in the Pharma Industry?

● How Is a Leader Different From a Manager?

● What Should Companies Look For in Employees When Hiring?

● Situational Leadership in Pharmaceutical Industry: Does That Work?

● How Can You Become a Good Leader in the Pharmaceutical Industry?

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Watch or read the full podcast and read the article at podcast.qualistery.com.

Ask questions and learn about GMP here: www.qualistery.com.

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This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, we have Philippe Tschopp from Glatt Pharmaceutical Services, a specialized CDMO. We will discuss with Philippe about CDMOs, what they are, how they work, and what a customer should look for in them. We’ll also ask him about Glatt Group as an example of how CMDOs work.

Who is Philippe Tschopp?

Philippe is the head of business development at Glatt Pharmaceutical Services. He has solid experience of well over a decade in business, sales and B2B digital marketing. He is also hugely enthusiastic about excipients and solid dosage forms.

Introducing our Co-Host:

Co-hosting this session alongside Yan Kugel is Ammar Badwy. Ammar is CEO and co-founder at Pharmaoffer, an online business-to-business platform for pharmaceutical ingredients.

In this blog post, you will learn:

● What is a CDMO and what it does?

● Glatt Group as a CDMO

● How to choose the right CDMO

● How Glatt Group deals with a project as a CDMO

● The trend of CDMOs in the near future

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Learn More About GMP at www.qualistery.com.

Watch or read the full podcast and read the article at podcast.qualistery.com.

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This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.

#Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

In this podcast, Yan Kugel and our guest, Àngels Llarch, talk about how pharma companies should host external audits. Àngels shares some really insightful tips regarding hosting an audit, coming right from her 20 years of vast experience in the pharmaceutical industry.

Currently working as API Compliance Head/Deputy RP at IMCD Switzerland AG, Àngels has more than two decades of solid experience, working in the Quality domain for several renowned pharmaceutical suppliers. She loves audits as they serve as a tool to discover new ways of implementing good manufacturing practices across the industry.

● What is an audit, and why is it performed?

● Do audits lead to the opening of pandora's boxes?

● How to prepare for an external audit

● Golden rules for hosting external audits by Àngels Llarch

● How to build trust with your auditor

Learn more about GMP on www.qualistery.com

Watch, listen or read the article on podcast.qualistery.com

Christy Mazzarisi is the Global Lead of Quality at CGI, supporting clients with automation quality systems.

In this episode, Christy talks to Yan Kugel and sheds light on the complex world of pharmaceutical automation and AI.

Listening to or watching this Qualitalks Podcast episode, you will learn about:

• What is the difference between intelligent automation (IA) and Artificial Intelligence (AI)?
• What is the value of AI and IA to pharmaceutical quality?
• How much money, time, and resources can AI and IA systems save for an organization?
• How to build and implement proper AI and AI networks?
• What are the challenges and the solution for AI and AI implementation?

Watch the full video episode on podcast.qualistery.com 

Learn more about GMP on www.qualistery.com

Find GxP consultancy work on www.paragonspoint.com

Yuval Shapiro is the founder of Quality with Value Ltd. A company that provides QA/RA for Medical Devices Services.

Yuval is a Quality Assurance & Regulatory Affairs Expert and consultant for products and companies primarily related to medical devices and telecom sectors. Additionally, he is a black belt Six Sigma certified from Johnson & Johnson. 

In this podcast episode, he discusses with Yan Kugel the history and evolution of Quality and why we are witnessing the death of Quality in his opinion. Then, he explains how to save it!

Watch the full video episodes on podcast.qualistery.com

Learn about quality and GMP for the top experts in the industry at www.qualistery.com

Suzzane Studinger has been a GMP consultant for over 9 years now. In this podcast episode, she explains why she decided to leave her steady job by Roche to become an independent consultant. She also reveals what the REAL job of the consultant is, what the challenges are behind it, and gives advice for employers for making the best of their consultants.

Watch the full video episode here.

Watch the full video episode on podcast.qualistery.com.

Master GMP on www.qualistery.com.

       -Yaron Ziv

Yaron is a pharmacist and the Head of QA at Chemipal, a medicinal distribution service provider. He is known in his community for his unconventional QA approach, making him an exceptional industry leader.

In this podcast episode, Yaron explains the fundamental role of the QA from his point of view - a service provider and not a slave of the regulations. He describes the benefit of this approach and how QA leaders can achieve that in their organizations.

The podcast is hosted by Yan Kugel and powered by Qualistery. 

In this podcast episode, Yan Kugel talked to Galit Lisaey about connecting the dots in data integrity.

Galit Lisaey is a Data Integrity consultant and Information Technology Project Manager, and Expert of 20 years.

Here are some of the points they touched during the discussion:

💡 Data life cycle and dot-connecting 

💡 The human factor in data integrity 

💡 Why people need to sit together and speak about risks 

💡 How to use audit trail correctly 

💡 How to set control points

💡 Why data integrity isn't mentioned in warning letters anymore.

Learn more about Qualistery at www.qualistery.com.

Watch the video episodes at podcast.qualistery.com.

Watch the full video episode on podcast.qualistery.com

Learn about the GMP online training offered by Qualistery at www.qualistery.com

Davidek Herron is the Head of Global Digital Platforms & Operations at Teva Pharmaceuticals.

His mission in Teva is to leverage digital technologies to get medicines to patients in need in a more efficient, quick, and safe way.

In this podcast episode, Davidek talks to Yan Kugel about the importance of digital services for pharmaceutical companies and explains why their success depends on digitalization.

He also gives precious tips on how to achieve successful digitalization in any company.

  Here are some of the topics you will hear about in this episode:  

💡 Why people are the most critical part of digitalization

💡 How to forecast Out-of-Stock situations in pharma

💡 How to help doctors identify the right medicines for the patients

💡 Why Pharma Must Embrace Change and Digitalize  

💡 Digital services on global scales  

💡 How digitalization can help companies Withstand hardships like Covid-19

💡 Why pharma is behind other industries in terms of digitalization

💡 How to encourage change and progress across an organization

💡 What is the future of the pharma industry

You can watch the full episode on podcast.qualistery.com from 2020-12-21. 

Learn more about us on www.qualistery.com

In this podcast episode, Vlatko Kantardjioski gives an amazing overview of equipment qualification in the pharmaceutical industry.

Vlatko is a Quality Assurance Specialist and served in leading positions in various equipment qualification projects.

Vlatko gives many expert tips and explains in details each stage in a pharmaceutical qualification:

- User Requirement Specifications
- Design Qualification (DQ)
- SAT (Site Acceptance Test)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)

Watch the full video episode on podcast.quaistery.com.

Learn more about our GMP courses on www.qualistery.com.

Borislav Milev is a CSV expert specializing in cloud computing. In this episode, Borislav will make everything about cloud computing much clearer.

Here are some of the things you will learn about, listening to, or watching this episode:

• What Are Cloud Services and How to Validate Them
  
• How to Validate Cloud Services
  
• How to Work Agile in Pharma on CSV
  
• How to Choose the Right Clouse Service Provider
  
• What to Negotiate With Cloud Service Providers?

Watch the full video on podcast.qualistery.com

In this podcast episode, Alex hall explains the right way to approach risk and which tools to use.

Here are some of the discussed topics:

💡 How to use ICH9 appropriately

💡 Tools to identify risks

💡 The first steps in any risk Management

💡 How to design your FMEA scoring system

💡 What is ALARP and how to use it in risk management?

💡 The Biggest Mistake People Do With FMEA

💡 What Are the Tools to Identify Risks?

Watch the video episode on podcast.qualistery.com

Master Risk Management in our live, virtual workshop- Quality Risk Management

In this podcast episode, Daniel Milek, a CSV expert from Data Integral Ltd, provides precious guidance on how you should go about your system validations. 

Here are some of the topics you will learn about, listening or watching this podcast episode:

💡 The Stages of a Successful CSV

💡 How Is CSV Different From Other Process Validations

💡 How to Train People in CSV

💡 How to Use Screenshots Right for CSV

💡 The Biggest Misconceptions With Computer Systems

Watch the full video episode on podcast.qualistery.com

Watch the full video episode on podcast.qualistery.com

Learn how to handle deviations effectively by attending our virtual live Master Class: Managing Deviations From A to Z

Thomas is head of contacts at EPM Scientific Switzerland, and during the podcast, he addresses the following topics:

Here are some of the things Thomas told me about:

💡 Who should consider becoming an independent consultant

💡 What are the advantages and challenges of independence?

💡 What roles are there for pharma quality experts

💡 How many years of experience do you need in pharma before you can become an independent consultant?

💡 Why CSV is such a hot topic right now

💡 How to start-up your consultancy career

💡 How to find the best contracts

💡 What can you expect to earn

Watch the full video episode on podcast.qualistery.com

Watch the video episode on podcast.qualistery.com

At Qualistery, we love talking to innovators within the pharmaceutical world. In this episode, Yan Kugel interviewed  Florian Hildebrand and Carla Peraferrer.

Florian is the CEO, and Carla is the Head of Quality at Qualifyze (Formally ChemSquare), a start-up that wants to change the way you conduct audits and qualify your suppliers. They provide auditing services across the world and believe that the future of supplier qualification lies within shared collective knowledge.

Here are some of the discussed topics:

💡 Who are Qualifyze and what is their mission?

💡 Why companies should share their audit reports globally

💡 What does qualification by the collective mean?

💡 How to adapt technologically to the pandemic reality 

💡 How to conduct a successful virtual audit 

You can watch the full video episode on 

podcast.qualistery.com or YouTube

In this podcast, Daniel Milek, a Data Integrity expert, explains what data integrity is and how to maintain it correctly.

Here are some of the discussed topics:

💡Why Data Integrity Is More Important Now Than Ever

💡What Is the Definition of Data Integrity?

💡What Are the Main Causes of Data Integrity Non-Compliance?

💡Who Are the Best People to Validate a Software?

💡What Are the Departments That Are Impacted the Most From Non-Compliance?

💡How to Write Good User Requirements Specifications

You can watch the video podcast here.

Yogesh Krishan Davé has been working in the pharmaceutical industry for more than 40 years now.
He is an EU Qualified Person and a consultant. During this long time, Yogesh has encountered many deficiencies from which most pharma companies suffer.

In this podcast, Yogesh has addressed deficiencies in two systems and explained how to tackle them:

1. Training

2. Deviations and CAPA handling

Here are some of the things that you will learn about in the podcast:

💡 Training - One of the Biggest Deficiencies in the Pharma Industry

💡 How to Motivate People Outside of QA to Be Part of the  Organizational Compliance

💡 Why The pharmaceutical industry should stop being arrogant

💡 How to Stop Chasing CAPAs and Wasting Men Hours

💡 How to Stop Losing Precious Time on Petty Deviations

You can watch the video episode on podcast.qualistery.com. 

Learn how to write efficient standard operation procedures (SOP) at our live virtual workshop - Writing Standard Operating Procedures (SOPs)

During his work in various pharmaceutical industry roles, Ammar Badwy has understood how difficult it is to find suppliers of raw materials that meet all the requirements. Therefore, Ammar has founded Pharmaoffer, a virtual marketplace that allows pharma companies to find qualified suppliers quickly and easily.

Here are some of the things, you will learn about in the podcast:

💡What is Pharmaoffer, and What Do They Offer?

💡Ammar's Journey from Cleanroom Repackaging to CEO

💡Why Finding New Qualified Suppliers Doesn't Have to Be Hard

💡The Future of the Digital Pharma Industry

💡Applications in Pharma Must Don't Have to Be So Complicated

In this episode of the Qualitalks Podcast, Alex Hall and Yan Kugel discussed Risk Management in the pharmaceutical industry.

Risk Management is a critical topic that is, unfortunately, misunderstood by many pharmaceutical companies. Many take the reactive approach instead of the proactive one, which can cause them a lot of money and risk customer lives. Any decision–making process about risks to product quality involves risk management to a greater or lesser extent.

Here are some of the things that we can learn in the pharma industry about Risk Management:

1. What is the definition of Risk?

2. How does it affect the pharma industry?

3. How to avoid these Risks in the pharma industry?

4. What is the Role of Upper Management?

5. What are the strategies for Risk Management?

Watch the video episode on podcast.qualistery.com

Master Risk Management in our live, virtual workshop- Quality Risk Management

To help you with your job, Matthew Lancaster shares valuables information that will help you navigate this challenging industry and maximize your career achievements.   

Matthew is the Director of Quality & Regulatory recruitment at Life Science People.  

Here are some of the topics Matthew Lancaster and Yan Kugel discussed in this episode: 

💡What is the main reason people fail at job interviews 

💡Which are the hottest position in the industry 

💡What to do if you didn't get the job you wanted  

💡Where in Europe it is easier to find your first job in pharma 

💡Why you SHOULD become a Qualified Person (QP) 

💡Should you, or should you not stay in one company for many years 

In this episode, Ashwani Tripath, head of compliance at Alembic Pharmaceuticals, explains what’s important to take into consideration when designing new aseptic manufacturing.

Here are some of the things you will learn from watching or listening to the episode:

• How to design a cleanroom
• Risk assessment for newly designed cleanrooms
• How to deal with unexpected deviations in a project
• What to keep in mind when you choose cleanroom equipment
• What Is the Most Complicated Equipment to Qualify
• What is the most complicated equipment to qualify
• How to avoid contamination by personnel

You can watch the full video here

Jennifer Kussauer studied communication. Nonetheless, she built a fantastic pharma career and functioned as an Associate Director, Head of Audits and Inspections Management at Merck KGaA, Darmstadt, Germany. Now she is an independent QA/QM Consultant.

In this podcast episode shares how she managed to build a great career without scientific education. We also dive into the fascinating world of GXP audits.

The full video of our talk will be available from Monday 08.06.2020 on www.qualistery.com.

By listening to this podcast, featuring Shoab Malek, you will have a clear idea about the role of GMP Auditor, how to become a one,  the challenges, tips, and much more.

Shoab Malek is an experienced & professional Pharmaceutical Consultant and GMP Auditor. He has faced many regulatory audits, which include USFDA, EU-GMP, PICs, UL Registrar LLC (USA), and 100+ vendor audits across India, China & Egypt.

Watch the video on qualistery.com