4th Edition Excellence in Cleanroom Operations, Quality Assurance & Control for Pharma and Biotech 2023 | TBM Group | 27 September 2023 | Vienna House by Wyndham Andel’s Berlin, Landsberger Allee 106, 10369 Berlin, Germany
Venue
Vienna House by Wyndham Andel’s Berlin
Vienna House by Wyndham Andel’s Berlin, Landsberger Allee 106, 10369 Berlin, Germany
What is Qwoted?
Qwoted is a free expert network: we help reporters connect with experts & we help those same experts build relationships with top reporters.
| Event Date |
Thu Sep 28 CEST - Fri Sep 29 CEST (about 1 year ago)
In your timezone (EST): Wed Sep 27 6:00pm - Thu Sep 28 6:00pm |
| Location |
Vienna House by Wyndham Andel’s Berlin
Landsberger Allee 106, 10369 Berlin, Germany |
| Region | EMEA |
Details
• New approach to the Risk Analysis and how to avoid subjectivity in Risk Analysis
• Qualification and Requalification of SIP and VHP Cycles
• Meeting Annex 1 Environmental Classification, Qualification and Requalification requirements with a Life cycle strategy.
• Lyophilization qualification
• Transfer of materials between different zones
• Aseptic process simulation (APS)
• Designing and effective environmental program. How often do we need to monitor? Where do we monitor?
• Real cases of Contamination Control Strategy
• Deviation Management with case studies and best practices
• Inspections and Trends with microbiology focus
• Understanding the Cleanroom Gowning Process
Speakers
2023 Speakers
Michele Simone
Quality Risk Management & Continual Improvements, Director Corporate Quality Management, Bracco, Switzerland
Di Morris
Qualified Person/qa Compliance Advisor, Pnr Pharma, Uk
James L Drinkwater
Head of Gmp Compliance and Aseptic Processing Support
Franz Ziel Gmbh
Head of Phss Aseptic Processing and Containment Special Interest Group, Phss-Pharmaceutical & Healthcare Sciences Society
Vedrana Despot Stefanovic
Process Development System Manager, Jadran Galenski Laboratorij (jgl), Croatia
Ivica Živko
Production Support Manager, Jadran Galenski Laboratorij (jgl), Croatia
Dennis Dürr
Process Validation Engineer, Roche, Germany
Sponsors & Partners
2023 Sponsor
BRONZE SPONSOR:
• Arcondis