Aseptic Fill & Finish of Biologics
Aseptic Fill & Finish of Biologics

Course Description

This 3-day course provides learning of the key challenges, regulatory expectations, applied technologies and best practices in Fill & Finish of Biologics including Biological and ATMP products. As Biological/ ATMP (Advanced Therapy) products require Aseptic processing where the principles of Quality Risk Management (QRM) apply and a Contamination Control Strategy (CCS) is required there are a number of key factors to take into account and these key points will be covered in training.
  • Regulations and regulatory expectations in Fill & Finish of biological products
  • Contamination Control Strategies (CCS)
  • Aseptic-Containment strategies
  • Bio-compatibility of biological products and gaseous disinfection residuals (vH202/VHP)
  • Risks assessments in contamination control and environmental monitoring
  • Regulatory expectations on Assurance of Sterility of Direct and In-direct product contact parts
  • Expectations in good cleanroom behaviour and good aseptic technique inside barrier technology
  • Technologies in Aseptic process filling of biological products and their integration into filling platforms
  • Digitalisation of EM (Environmental monitoring) and PM (Process monitoring) data
  • Trends in Aseptic manufacturing
  • Keep current and learn about new regulation changes e.g., EU GMP Annex 1 and the key points that impact biological product Fill & Finish and possible compliance gaps.
  • Learn about the full expectations of applying QRM and what a CCS is expected to cover in the process of defining the approach to sterile product manufacturing including organisational, technical and procedural control measures.
  • Understand the expectation of collective effectiveness with EM & PM with trend metrics that drive continuous improvement through the product life cycle.
  • Learn about the key challenges related to biological product filling including sensitivity to disinfection oxidising agents (VHP) and how to manage/control impact on products to meet regulatory and product quality requirements.
  • Learn about the technologies that are integrated into filling process platforms to meet the various critical quality attributes of biological products.
  • Learn about best practices in biological product aseptic manufacturing and regulatory observations in non-compliance.
  • Learn about the trends and future of biological product Fill & Finish.

Aseptic Fill & Finish of Biologics

24 - 26 June 2024, Live Online Training
Regular price €1.850,00
Unit price
per 
James L. Drinkwater

James L. Drinkwater is the current Head of GMP Compliance at Franz Ziel Germany. James is based in the UK for the global role and separately supports the Not-for-profit society: Pharmaceutical and Healthcare Sciences Society: PHSS an educational platform in GxP. James is the ex-Chairman (10 years) of the PHSS and currently Co-leads the Annex 1 and CCS Guidance focus groups.

START TIMES

1:30 PM Vienna time

12:30 PM London time

7:30 AM New York time

Group discounts available upon request - contact us.

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Course Description

This 3-day course provides learning of the key challenges, regulatory expectations, applied technologies and best practices in Fill & Finish of Biologics including Biological and ATMP products. As Biological/ ATMP (Advanced Therapy) products require Aseptic processing where the principles of Quality Risk Management (QRM) apply and a Contamination Control Strategy (CCS) is required there are a number of key factors to take into account and these key points will be covered in training.
  • Regulations and regulatory expectations in Fill & Finish of biological products
  • Contamination Control Strategies (CCS)
  • Aseptic-Containment strategies
  • Bio-compatibility of biological products and gaseous disinfection residuals (vH202/VHP)
  • Risks assessments in contamination control and environmental monitoring
  • Regulatory expectations on Assurance of Sterility of Direct and In-direct product contact parts
  • Expectations in good cleanroom behaviour and good aseptic technique inside barrier technology
  • Technologies in Aseptic process filling of biological products and their integration into filling platforms
  • Digitalisation of EM (Environmental monitoring) and PM (Process monitoring) data
  • Trends in Aseptic manufacturing
  • Keep current and learn about new regulation changes e.g., EU GMP Annex 1 and the key points that impact biological product Fill & Finish and possible compliance gaps.
  • Learn about the full expectations of applying QRM and what a CCS is expected to cover in the process of defining the approach to sterile product manufacturing including organisational, technical and procedural control measures.
  • Understand the expectation of collective effectiveness with EM & PM with trend metrics that drive continuous improvement through the product life cycle.
  • Learn about the key challenges related to biological product filling including sensitivity to disinfection oxidising agents (VHP) and how to manage/control impact on products to meet regulatory and product quality requirements.
  • Learn about the technologies that are integrated into filling process platforms to meet the various critical quality attributes of biological products.
  • Learn about best practices in biological product aseptic manufacturing and regulatory observations in non-compliance.
  • Learn about the trends and future of biological product Fill & Finish.

"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

Aseptic Fill & Finish of Biologics

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