65 +
Users
5 +
Sponsors
7 +
Speakers
FEATURED TOPICS
- 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
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
Matthias Mikkelsen
EMEA Flexicon Subject Matter Expert
Watson Marlow Flexicon, Denmark,
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
Varadharaj Vijayakumar
Senior Subject Matter Expert-Aseptic Fill Finish
WuXi Biologics, Germany
Alicia Ruiz Mahillo
Group Quality- Microbiology & Sterility Assurance Manager
COMPASS by Famar, Spain
Valerie Mulholland
Senior Director/Principal Consultant
GMP Services, Ireland
VERENA VOLLENBROICH-MARQUARDT
Head of European Quality Compilance
WuXi Biologics, Germany
Sebastian Scheler
Managing Director & Chief Methodologist, Co-Founder
Innerspace, USA
Gautam Bhadanee
Manager Quality Assurance
CuraTeQ Biologics, India
Dr. Zahra Halvorsen
Senior Compliance Consultant
Arcondis Group, Switzerland
Valentino Ducati
Management Consultant
Arcondis Group, Switzerland
Dr. Birte Scharf
Senior Scientist – GMP Compliance
Franz Ziel, Germany
VENUE
SPONSOR
CLEANROOM OPERATION FORUM - HIGHLIGHTS
CLEANROOM OPERATION FORUM - HIGHLIGHTS
Press & Articles
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