|
|
|
|
|
|
|
|
|
|
| Email |
enquiry@ipacanada.com
|
|
| Category |
Health: Medicine
|
|
| Category 2 |
Science: Chemistry
|
|
| Category 3 |
Science: Biotechnology
|
|
|
|
|
|
|
|
|
|
| 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
|
|
|
|
