ICH Q7 - Essential GMP Guide for API’s For Pharmaceutical, Biopharmaceutical and Allied Industries

Venue: Toronto

Location: Toronto, Canada

Event Date/Time: Apr 28, 2008 End Date/Time: Apr 29, 2008
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Description

An Important Two Day Comprehensive & Interactive Course with Workshops and Case Study Discussions on:

- GMP considerations tied in to ICHQ7
- Requirements and guidelines
- Costs and benefits of manufacturing Excipients in compliance with ICHQ7A guidelines
- Implementation of ICHQ7
- Quality Management and Creating Quality Units
- Record and Documentation
- Differences in Registration for Market Authorizations
- Material Management
- Impact of ICHQ7 on Second and Third Parties
- Evaluation of Suppliers
- Cleaning Validation
- GMP in Laboratory Control
- Change Control
- ICHQ7 Section 18, A Chapter On Its Own?
- Differences between API’s manufactured by Cell Culture(&)/ Fermentation to API’s manufactured by Chemical Synthesis
- Audit Preparation with Consideration to GMP and ICH Requirements

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Types