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Quality Requirements for Biologics
Quality Requirements for Biologics

Course Description

Join us for three days of engaging insights and expert knowledge at our Biologics course.

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.

  • Introduction to the health benefits of biologics
  • Exploration of regulatory frameworks, quality and GMP requirements by EMA, FDA, and other global entities
  • Streamlining quality systems and processes for excellence in biologics production
  • Managing collaborations with CMOs effectively
  • Ensuring material and supplier qualification standards are upheld from source to product
  • Strategies for tackling manufacturing complexity and achieving efficient production
  • Overview of biologics manufacturing processes, including seed lot and cell bank management, as well as the manufacturing of the drug substance and IMPs
  • Strategies for combating contamination and maintaining ethical practices in animal welfare
  • Utilizing state-of-the-art facilities and advanced equipment for biologics manufacturing
  • Importance of process validation, release specifications, comparability studies, process
    changes and analytical methodical development in ensuring product reliability
  • Understand the regulatory landscape
  • Overview over GMP and quality requirements for the manufacture
  • Learn about the development and the requirements for manufacturing
  • Modern process validation concepts and biologics
  • How to implement effective process changes
  • Implementation of analytical methods for biologics and requirements
  • Release specification compared to in-process control requirement

Quality Requirements for Biologics

18 - 20 June 2024, Live Online Training
Regular price €1.850,00
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

1:30 PM Vienna time

12:30 PM London time

7:30 AM New York time

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Course Description

Join us for three days of engaging insights and expert knowledge at our Biologics course.

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.

  • Introduction to the health benefits of biologics
  • Exploration of regulatory frameworks, quality and GMP requirements by EMA, FDA, and other global entities
  • Streamlining quality systems and processes for excellence in biologics production
  • Managing collaborations with CMOs effectively
  • Ensuring material and supplier qualification standards are upheld from source to product
  • Strategies for tackling manufacturing complexity and achieving efficient production
  • Overview of biologics manufacturing processes, including seed lot and cell bank management, as well as the manufacturing of the drug substance and IMPs
  • Strategies for combating contamination and maintaining ethical practices in animal welfare
  • Utilizing state-of-the-art facilities and advanced equipment for biologics manufacturing
  • Importance of process validation, release specifications, comparability studies, process
    changes and analytical methodical development in ensuring product reliability
  • Understand the regulatory landscape
  • Overview over GMP and quality requirements for the manufacture
  • Learn about the development and the requirements for manufacturing
  • Modern process validation concepts and biologics
  • How to implement effective process changes
  • Implementation of analytical methods for biologics and requirements
  • Release specification compared to in-process control requirement

"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

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

Medical-Devices-Certificate-Course

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