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 Brochure
Here
you can find the programme for the European Conference on Good Manufacturing Practices for Pharmaceutical Excipients in PDF format.
Agenda
Monday, 1 December 2008
- Update on EU GMP Guide Chapter 5 Revision
10.15 - 11.15 h
- 'Update on EC Certain Excipients legislation'
11.15 - 12.15 h
- FDA Update on the Control of Excipients
13.30 - 14.30 h
- IPEC Guide as an appropriate guidance for Excipients manufacturers -
Comparison to ICH Q7
14.30 - 15.30 h
- Design of an effective compliance programme for Excipients
manufacturing
16.00 - 17.00 h
- Excipients certification - schemes, standards, value
17.00 - 18.00 h
Panel Discussion
Tuesday, 2 December 2008
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Parallel Sessions
Session 1: Auditing an Excipients Manufacturer
Session 2: Change Control Management
Session 3: Excipients for Use in Parenteral Products |
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- MHRA Voluntary Inspection Scheme
10.15 - 11.15 h
- How to design risk based manufacturing strategies to meet customers'
GMP expectations
11.15 - 12.15 h
- The role of quality agreements in Excipients supply
13.30 - 14.30 h
- Excipients pedigree - Repackaging, relabeling, recertification of
Excipients
15.00 - 16.00 h
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