Have you ever wondered what all needs to be considered when it comes to pharmaceutical packaging? In the last PEP talks podcast episode of the year, our experts from Körber, Erk Wolters and Ruaidhri O'Brien, talk about something we take for granted in everyday life. Together, we discover the world of pharmaceutical packaging and learn more about blister packs or current trends in the industry like LSC – Late Stage Customization.

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We’ve all seen both examples, when it’s done right, acceptance and when it’s done wrong, rejection or worse. In this episode, we are talking about Change Management. Our two experts, Daniel R. Matlis and Sandra Rodriguez of Axendia, Inc., have guided projects through the Change Management waters and have come out right side up. Together we uncover the pitfalls to avoid and the keys to successful Change Management.

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In this episode, we are delving into the groundbreaking world of cell & gene therapy (CGT, or ATMP) - the fastest growing market within the pharmaceutical industry. Cell & gene therapy can set completely new standards in medicine and opens the possibility of curing even the most difficult diseases. Our expert, Dr. Judith Koliwer, explains the basics of CGT and highlights the differences compared to traditional biotech production.

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Are you new to the biopharma industry? If so, then this 20-minute episode is for you! Together with Dr. Gary Gilleskie from BTEC, the Biomanufaturing Training and Education Center at North Carolina State University, we explain the basics of biopharmaceutical manufacturing. How are biopharmaceuticals different from traditional pharmaceutical products? Do cell and gene therapies fall into the category of biopharmaceuticals? Do you know the difference between the upstream and downstream parts of the manufacturing processes? We tackle these questions and more in this episode of PEP talks.

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What do technology and the cloud hold in store for the future of pharmaceutical manufacturing? What barriers does the life sciences industry face in adoption and implementation of this technology? Is it reliable and secure enough to meet compliance regulations within this industry? Our panelists address these concerns and discuss the use of corporate cloud technology in pharmaceutical manufacturing. This panel was recorded as part of Connext America, the Pharma Software Summit by Körber.

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When the pandemic hit, the highly regulated pharmaceutical and healthcare industries were arguably the most affected. Our panelists discuss the nature of disruptive events and what valuable learnings and process updates can be gained from disruptions such as the global COVID pandemic. We hope you enjoy and gain new perspective from this lively conversation, taken from Connext America, the Pharma Software Summit by Körber!

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In pharmaceutical and biotech production, it is crucial to link the right data and understand it in the right way. In this episode, we explore what digitization means, what steps companies need to take to digitize their production, and whether suppliers are keeping pace with the digital revolution.

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In the second part of the series, we continue our conversation about Pharma 4.0 and answer the question of what comes first – the factory hardware or the software? We also find out best practices of how to select the ideal software and hardware based on the manufacturer’s goals and requirements.

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At this point, Pharma 4.0 could easily be a category of a popular game show. But, would the players get all the questions right? Is there only one correct answer? In the start of a two-part series we will explore the world of Pharma 4.0. We will define the buzzwords and discuss how to set goals for smart manufacturing – whether it is for a Greenfield plant or an established pharma factory.

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Do all documents need to be signed in one color? Does the FDA not accept review by exception? What is real and what is a myth when it comes to FDA regulations for pharmaceutical manufacturing?

In our first episode of PEP talks, we’ll clear up some myths and misinterpretations of regulatory requirements with our expert guest Daniel R. Matlis, President and Founder of Axendia, Inc. You won’t want to miss this discussion as commonly held beliefs get busted.

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