IPEA
GMP Three-Day
Auditing Workshop
December 11
- 13, 2007
|
Registration
Fees
|
Three-Day
Workshop
|
|
Employees
of
IPEC Europe
Member Companies
|
1500
Euro
|
|
Nonmembers
|
1700
Euro
|
*hotel
fees (not included) 165 Euro/single
Credit cards accepted.
8:00-9:00am Registration
8:30-9:00am Continental Breakfast
9:00-5:00pm Workshop Session
Workshop
Content
DAY
1
- The
Different Issues Associated with
Excipient GMP Auditing
- Audit
Planning & Use of Pre-Questionnaires
- Alternate
Approaches to On-Site Auditing
- Interpersonal
Skills Associated with Auditing
- Auditing
Techniques
- Recording
Observations
DAY
2
- Comprehensive
Discussion & Review of Excipient
Auditing Checklists
- Applying
audit techniques to GMP checklist
categories
- Typical
audit observations for checklist
categories
- Rating
Audit Observations
DAY
3
- Hands-on
Mock GMP Audit
- Audit
Observations: writing & rating workshop
- Presentations
and Feedback from Audit Results
- Locating
Resources on Excipient GMPs & Auditing
- Excipients
vs. APIs
|
|
