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Quality Requirements for Biologics
Quality Requirements for Biologics

Course Description

Immerse yourself in the world of biologics with an introduction to their health benefits and explore the stringent regulatory standards set forth by EMA, FDA, and beyond. Learn how to ensure quality and safety while navigating global guidelines. Gain a comprehensive overview of manufacturing drug substances and investigational medicinal products (IMPs), covering everything from quality assurance to process validation. Discover state-of-the-art facilities, equipment excellence, and strategies for precision in fill and finish. Develop a deep understanding of managing process changes, analytical methods for biologics, and the importance of release specifications compared to in-process control requirements. Navigate the regulatory landscape, define precision parameters, and implement continuous quality monitoring. Don't miss the opportunity to expand your knowledge and engage with leading experts in the field.

  • Regulatory framework 
  • Quality & GMP requirements 
  • Manufacturing of the drug substance & IMPs 
  • Process validation 
  • Managing process changes 
  • Analytical methods 
  • Release specification vs IPC requirements 
  • Understanding the regulatory landscape
  • Overview of GMP and quality requirements for manufacturing
  • Learning about development and basic requirements for manufacturing
  • Modern process validation concepts and biologics
  • How to implement effective process changes
  • Implementation of analytical methods for biologics and basic requirements
  • Release specification compared to in-process control requirements
  • Interactive Break-Out Sessions: Experience exchange with you colleagues worldwide

Quality Requirements for Biologics

June 18 - 20, 2024, Live Online Training
Regular price $2,250
Unit price
per 
Dr. Felix Kern

Dr. Felix Tobias Kern is the Associate Director - Head of Compliance Launch and Technology Center at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich (Germany). He is an expert pharmacist for pharmaceutical analytics and pharmaceutical technology.

START TIMES

7:30 AM New York time

12:30 PM London time

1:30 PM Vienna time

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Course Description

Immerse yourself in the world of biologics with an introduction to their health benefits and explore the stringent regulatory standards set forth by EMA, FDA, and beyond. Learn how to ensure quality and safety while navigating global guidelines. Gain a comprehensive overview of manufacturing drug substances and investigational medicinal products (IMPs), covering everything from quality assurance to process validation. Discover state-of-the-art facilities, equipment excellence, and strategies for precision in fill and finish. Develop a deep understanding of managing process changes, analytical methods for biologics, and the importance of release specifications compared to in-process control requirements. Navigate the regulatory landscape, define precision parameters, and implement continuous quality monitoring. Don't miss the opportunity to expand your knowledge and engage with leading experts in the field.

  • Regulatory framework 
  • Quality & GMP requirements 
  • Manufacturing of the drug substance & IMPs 
  • Process validation 
  • Managing process changes 
  • Analytical methods 
  • Release specification vs IPC requirements 
  • Understanding the regulatory landscape
  • Overview of GMP and quality requirements for manufacturing
  • Learning about development and basic requirements for manufacturing
  • Modern process validation concepts and biologics
  • How to implement effective process changes
  • Implementation of analytical methods for biologics and basic requirements
  • Release specification compared to in-process control requirements
  • Interactive Break-Out Sessions: Experience exchange with you colleagues worldwide

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Quality Requirements for Biologics

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