Technology Transfer Planning

Venue: Toronto

Location: Toronto, Canada

Event Date/Time: Oct 06, 2008 End Date/Time: Oct 07, 2008
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Description

A TWO DAY COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES & WORKSHOPS ON:

- Principles of the Technology Transfer Process
- Technology Transfer cGMP Review & Regulatory
Expectations
- Transfer of a Manufacturing Process
- Tech Transfer and Process Validation for APIs
- Determination of Process-Facility Fit
- Equivalency of Batches
- Application of ICH Q9 and Risk Management
- Identifying Critical Process Parameters
- Process Modeling and Risk Assessment
- Using Quality by Design (QbD) in Providing a Rugged Process
- Analytical Method Transfers and Troubleshooting
- Designing Method Transfer Protocols
- Filing a Development Report
- Handling Changes Post Technology Transfer (SUPAC)
- Lifecycle Considerations for Change Control and Validation Review
- Transfer of Information-Documentation
- Project Management Strategies
- Global Outsourcing Strategies
- Planning International Technology Transfers
- Building a Technology Transfer Team
- Legal Requirements for Technology Transfer

Venue

Types