| 08.00 - 08.30 |
Welcome,
Introduction, Presentation of the Speaker |
| 08.30 - 10.00 |
Regulatory
Requirements for Qualification
- Europe
- FDA
- Harmonisation
- Definitions
|
| 10.00 - 11.00 |
Management of
Documents, Documents required
- Validation Policy
- Validation master plan
- Documents for the Performance of
Qualification/Validation
- SOPs
- Responsibilities
- Validation Team
- Presumption for
Qualification/Validation
|
| 11.00 - 11.15 |
Break
|
| 11.15 - 12.45 |
General Aspects of
Qualification
- Qualification Phases, DQ, IQ,
OQ, PQ
- Qualification of Existing
Systems and Equipment
- Qualification of Already
Existing Systems (Same as above???)
- Requalification
|
| 12.45 - 13.45 |
Lunch
|
| 13.45 - 15.00 |
Performance of
Qualification
- SOPs needed
- How to Write a Qualification
Plan, Content a Main Points
- Performance of Qualification
- Tests
- Data
- Content of Documents
- How to Write a Qualification
report, content and Main Points
|
| 15.00 - 15.15 |
Break |
| 15.15
- 16.45 |
Types of Validation
- Process
- Hygiene
- Cleaning
- Concurrent
- Bracketing
- Matrixing
- Retrospective
- Analytic
|
| 16.45 - 17.15 |
Discussion |
| |
|
| Day 2 |
|
| 8.30 - 10.00 |
Performance of
Validation
- SOPs necessary
- How to Write a Validation Plan
- Performance of Validation
- Tests
- Data
- Content of Documents
|
| 10.00- 10.15 |
Break |
| 10.15 - 11.15 |
Guideline on
Validation of Analytical Methods
- Content and Implementation
- SOPs necessary for Validation
- How to Write a Validation Plan
- Methodology and Performance
- How to write a Validation Report
- Presumption for Validation
|
| 11.15 - 12.30 |
Support of
Qualification and Validation
- Quality Management System
- Risk Analysis
- Calibration/Maintenance
- Change Management
- Audit of Qualification and
Validation
|
| 12.30 - 13.30 |
Lunch |
| 13.30 - 14.30 |
External
Qualification and Validation
- Contract Manufacturer
- Qualification/Validation by
Supplier
|
| 14.30 - 15.30 |
Discussion |
