Entry Level Process Validation for Biotechnological Products - EU edition MasterClass
05-08 September, 2023
This masterclass will introduce participants to QbD concept, process validation and regulatory requirements
This course will cover the definition of QbD concept and process validation, describing all key studies and scientific requirements for developing your biotechnological product.
05-08 September, 2023, Virtual
Time Zone: UTC/GMT+1 /CET
Overview
This masterclass will introduce participants to QbD concept, process validation and regulatory requirements, and will provide as well keys to successfully drive your product to market authorization.
This course will cover the definition of QbD concept and process validation, describing all key studies and scientific requirements for developing your biotechnological product. It will describe FDA and European guidelines, including the review of the IND and CTD documents, in term of regulatory expectations, to guide you to the market registration of your product.
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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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