Afleveringen
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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.
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In this podcast episode, Nathan Roman joins us to discuss the importance of temperature-controlled transport and the two types of storage solutions: active and passive.
He explains that the cold chain includes all food, medicine, drug products, and vaccine-related equipment and procedures. Nathan mentions that understanding temperature-controlled options is essential to ensure the best-controlled system is chosen to protect temperature-sensitive pharmaceutical products. He also discusses the pros and cons of these cooling solutions and suggests that the decision on which solution is best for your purpose should be based on your criteria, such as cost, electricity, and safety.
The conversation also covers the need to ensure that products arrive safely in the first mile of the supply chain and how to ensure that temperature-sensitive goods are transported, handled, and stored properly.
Tune in now to better understand cold chain solutions, how to monitor them, and how they can help you in your industry.
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Watch or read the full podcast and read the article at: https://podcast.qualistery.com/what-cold-chain-solutions-are-there-and-how-to-monitor-them-nathan-roman
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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
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Zijn er afleveringen die ontbreken?
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In the latest episode of Qualitalks, Yan Kugel and Nathan Roman dive deep into the world of qualification protocols and share their insights on writing effective ones.
Nathan explains that a qualification protocol is a written plan describing the qualification process and how the qualification will be conducted. He emphasizes the importance of understanding the project and its requirements and suggests using templates or a basic protocol format to ensure consistency in documentation preparation.
In addition, Nathan discusses the evolution of qualification protocols, including the incorporation of paperless validation and the need to stay up-to-date with new technologies.
Listening to the podcast, or watching the video, among others, you will learn about:
-What is a qualification protocol?
-When should you have it ready?
-What are the prerequisites?
-What should it include?
-And what are some common problems?
Make sure you don't skip this enlightening and captivating dialogue. Listen in immediately!
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Watch or read the full podcast and read the article at: https://podcast.qualistery.com/temperature-mapping-all-you-need-to-know-about-good-qualification-protocol-nathan-roman/
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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
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Are you looking to learn more about how to validate a temperature-controlled chamber?
Look no further! In this episode, we have Nathan Roman, one of the top experts in Temperature control mapping, to help us understand the different steps and regulations when validating a temperature-controlled chamber in the Health & Life Science industries.
Nathan will share his knowledge on the need for temperature-controlled chambers, the various types of chambers, regulations, common mistakes to be avoided, and resources for keeping up with best practices
Topics range from:
What a temperature-controlled Chamber is, and why are those needed? What types of temperature-controlled chambers are available, Which regulations exist, which steps of the validation process are most challenging, What common mistakes during the validation to avoid? Plus, get recommendations for resources to stay current with regulations and best practices.-----------------------------------------------------------------------------------------------------
Watch or read the full podcast and read the article at: https://podcast.qualistery.com/steps-to-validating-a-temperature-controlled-chamber-nathan-roman
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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
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One of the most common concerns in GxP quality is maintaining the temperature of laboratory and manufacturing storage environments. Temperature Mapping, also known as thermal mapping, is an activity performed on temperature-controlled chambers often used to track temperature changes within the storage space over a long period.
This podcast episode focuses on the importance of temperature mapping studies and why they are so critical for pharmaceutical compliance. Our guest speaker is Nathan Roman, one of the top experts in Temperature control mapping who help people in the Health & Life Science industry learn how to implement and carry out temperature mapping studies and equipment qualifications (IQ, OQ, PQ).
Listing to the podcast, or watching the video, among others, you will learn about:
What are temperature mapping studies, and why are they so critical for pharmaceutical compliance? Where is thermal mapping required, and why? What is the process for a temperature mapping study? What is the most challenging part of your job? What do most people do wrong with thermal mapping, and what would be your suggestion to improve? What resources can help pharma professionals stay updated with the latest regulations and trends?So tune in to learn all there is to know about thermal mapping and its impact on pharmaceutical compliance!
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Watch or read the full podcast and read the article at: https://podcast.qualistery.com/what-is-thermal-mapping-and-why-its-so-important-nathan-roman/
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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
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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?------------------------------------------------------------------------------------------------------
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
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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?------------------------------------------------------------------------------------------------------
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
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Excipients are an integral part of any pill, and they are becoming more complex with time. The complexity plays a significant role from the regulatory aspect and their role in the drug's function.
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?------------------------------------------------------------------------------------------------------
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
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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------------------------------------------------------------------------------------------------------
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
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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
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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
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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
------------------------------------------------------------------------------------------------------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
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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
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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
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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
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In this podcast, we talk about CMOs and CDMOs, i.e., Contract Manufacturing Organizations.
What they are, how they work, their past and expected future, and everything you need to know about them as a startup, a company, or just as an individual.
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
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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
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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.
Who 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 over 25 years and holds leading-edge expertise in data integrity, pharmaceutical validation, international team management, and computer science.
In this podcast episode you will learn:● 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
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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
------------------------------------------------------------------------------------------------------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
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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.
Who's Àngels Llarch?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.
In This Podcast Episode, You Will Learn:● 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
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