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ECA - Current Aseptic Compliance
Current Aseptic Compliance (25 March 2020)
Reasons to attend this conference:
- You will be informed on the current status of EU Annex 1 revision
- You will learn how current GMP and production requirements have to be implemented in sterile manufacture
- You will get case studies from pharmaceutical companies
EU GMP Annex 1 on sterile medicinal products is currently under revision. A first public draft from 2017 was intensively discussed. What are the consequences of this discussion and what are the next steps to a final document will be explained in this conference.
Two systems are on the market – RABS (Restricted Access Barrier System) and Isolators. But only isolators are referred to by the US FDA as advanced aseptic technology.
This conference will focus on current questions of barrier systems coming from FDA regulations as well as from the revised EU-GMP Annex 1, and it will specifically address the subject from the perspectives of pharmaceutical operators, planners and engineers.
Gert Moelgaard, ECA Validation Interest Group
Jörg Zimmermann, Vetter Pharma-Fertigung
The event is directed at specialists from the pharmaceutical industry as well as at engineers and planners who have to deal with current aseptic regulations in their daily practice. It particularly addresses the departments:
- Quality assurance
- Engineering / Technology
Case Study AbbVie: The new Biologics Site in Singapore
Dr. Rolf Ratke, Abbvie
Ronan Mc Garvey, Abbvie Singapore
- The Site strategy
- Products, processes & equipment
- Cooperation with EMA, blueprint to prepare for the successful pre-approval-inspection
- From start- up to realization until approval
Status of Annex 1 revision?
Dr. Beate Reutter, Landeesamt für soziale Dienste Schleswig-Holstein, Kiel, Germany
Environmental Monitoring in Modern Biopharmaceutical DP Facilities – A Proposal for a Harmonized Risk Based Approach for Selecting Monitoring Points and Defining Monitoring Plans
Patrice Wery, GSK Vaccines
- What about Biophorum, the group working on this Risk Assessment?
- Why do we need a harmonized Risk Assessment tool?
- Explanation of the tool in a step by step approach
- First feed-back of authorities
- A practical example to illustrate how it works
Case Study: Media Fill Design for aseptic Blow Fill Seal Filling
Dr. Martin Haerer, Rommelag CMO
- General Media fill concept
- Bracketing concept
- Intervention procedure
- Operator involvement
Single Use Bioreactor Platform(SUB) for Microbial Fermentation in a GMP manufacturing facility
Dr. Sofia Venceslau, Genibet
- Benefits for GMP production
- Broaden the use of SUBs to expand bacteria and yeast cells
- Main faced challenges
Challenges and Opportunities of Aseptic Manufacturing Process Transfers
Dr. Martin Schwab, Vetter Pharma-Fertigung
- Manufacturing Process Transfers / Clean Room Transfers: Background, Drivers, Characteristics
- Technology Transfer: Like for like, process optimization, gap- and risk-analysis, challenges
- Lessons learned and outlook
Areas of focus for Auditors of Sterile Operations
Hesham Elrayes, B.Braun
- Areas to be focused
- APRs (PQRs)...
- Adverse Events – Signal Detection
- What should I spend some time looking at here...?
- Batches Manufactured
- Analytical Data & Trend Analysis
- Qualification status of equipment
- Quality Agreements
- Sterilization cycles
- Environmental Monitoring
- Assessment tools to focus on key process and environmental elements relative to audit aseptic Lyophilization process