- 22/11/2018 - 23/11/2018
- Munich, Germany Leonardo Royal Hotel Munich
Your prominent trainer:
- Dr. Michael Braun
- Director Late Stage Drug Product Development
- Boehringer Ingelheim Pharma, Germany
Key topics:
New Guidance and Requirements for Process Validation
Continued Process Verification
Process Design Stage: Key input for Product and Process Quality
Technology Transfer
Process Performance Qualification
Risk Assessment & Control Strategy Tools
Takeaways & Special Features
Understand
• Industry approaches for Technology Transfer and Process Validation applying QbD principles
• Risk assessment methodologies (FMEA vs Process Risk Map)
Learn
• An outline of proven best practice in process validation and technology transfer
• About Process performance qualification and Continued process verification
Gain
• Regulatory insights and guidance (EU & FDA) how to perform Technology Transfers and Process Validation
• Practical knowledge and tools during two interactive sessions and workshops
REGISTRATION
Delegate fee
JOIN US IN MUNICH
Leonardo Royal Hotel Munich
Moosacher Straße 90, 80809 Munich, Germany
CONTACT US
- Andrea Weber
- Sr. Manager for Pharma
- Phone: +421 257 272 232
- Email: event.inquiries@fleming.events