Process Validation for Biotechnological Products - US edition MasterClass
22-25 May, 2023
This MasterClass will provide best understanding on how process validation for biotechnological products, which is the collection & evaluation of data from the process design stage.
This MasterClass will provide best understanding on how process validation for biotechnological products, which is the collection & evaluation of data from the process design stage through commercial production.
22-25 May, 2023, Virtual
Time Zone: Eastern Standard Time (EST) / UTC−05:00
Overview
Process Validation Pharma Online MasterClass aims to provide deeper understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production, would be appropriately designed and executed to establish scientific evidence that a manufacturing process is capable of consistently delivering quality product.
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In 2003, I moved to Serono in Geneva as Global Product Team Leader in charge of managing the development of a recombinant Ig-fusion protein for the treatment of autoimmune diseases, moving that product from Phase I to Phase III.
As of November 2006, I’ve been appointed Vice-President, Head of Biotech Process Sciences at MerckSerono, based in Vevey, Switzerland, in charge of developing and validating the manufacturing processes for biotechnological products. In that context, whereas Serono was mainly using perfusion processes for recombinant hormones and cytokines, we moved the company to large-scale manufacture of monoclonal antibodies using proprietary chemically-defined cell culture media and feeds. After our participation to the FDA’s pilot program on Quality by Design, the concepts described in ICHQ8 (R2) and ICHQ11 were implemented in our approach to gain process understanding. It was concluded by issuing a modernized approach for process validation at Merck (Darmstadt, Germany). More recently, we have introduced advanced processes such as intensified fed-batch and continuous downstream processing.

RECOMMENDATION
Who should attend?
• Process development scientists and managers
• CMC development program managers
• Pharmaceutical development scientists and managers
• Manufacturing managers
• QC and stability control managers
• Heads of Quality Assurance
• Drug Regulatory Affairs managers
Testimonial
Our success stories
"High attention to detail in course content and very well delivered"
Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom
Our success stories
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland
Our success stories
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany
About GLC
Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.
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