| 08.30 - 09.00 |
Welcome, Introduction,
Presentation of the Speaker |
| 9.00 - 10.30 |
Regulatory
Requirements in the Pharmaceutical Industry
- FDA CFR Parts 200, 600
- GMP Regulation, WHO, Europe
Duties of the Quality Control Department: an Overview
- Definitions differences between
the Requirements
- Differences between Quality
Control and Quality Assurance
|
| 10.30 - 10.45 |
Break |
| 10.45 - 11.45 |
Documental Requirements
on Qualification and Validation
- Qualification/Validation
Policy
- Validation Master Plan
- Documents for the Performance of
Qualification/Validation
- SOPs
- Responsibilities
- Presumption for
Qualification/Validation
- Qualification/Validation Report
|
| 11.45 - 13.00 |
Validation of
Analytical Methods
- ICH Guideline
- SOP's necessary for
Validation
- How to Write a Validation
Plan
- Methodology and
Performance
- How to write a Validation
Report
- Presumption for Validation
|
| 13.00 - 14.00 |
Lunch |
| 14.00 - 15.15 |
Out of Specification
(OOS)
- The Barr Case
- FDA Guideline for OOS
- SOP for OOS Working on OOS
- Failure Investigation
- Implementation of Other
Departments
|
| 15.15 - 15.30 |
Break |
| 15.30 - 16.30 |
Sampling
- Sampling Plan
- Performance of Sampling
- Pitfalls and Failures of
Sampling
- SOP for Sampling
- What to Sample
|
| 16.30 - 17.15 |
Batch Release
- SOP for Batch Release
- Basic Documents for Release
- Responsibilities
- Performance of Release
|
| 17.15 - 17.45 |
Discussion of Day 1 |
| |
|
| |
Day 2 |
| 09.00 - 10.15 |
Stability Testing
- Stability Testing Plan
- Different Kinds of Testing
- Ongoing Testing Performance of
Testing Stability Report
|
| 10.15 - 10.30 |
Break |
| 10.30 - 11.45 |
SOP/Documentation
- How to Write a SOP
- Content of a SOP
- Nuts and Bolts of SOPs
- Distribution and Maintenance of
Documents
- Archiving
|
| 11.45 - 13.00 |
Selfinspection/Auditing
- Inspection Program
- Inspection Plan
- Performance of an Inspection
- Dos and Don'ts
- Supervision of External
Contractors
- Inspection Report Qualification
of Auditors
|
| 13.00 - 14.00 |
Lunch |
| 14.00 - 15.00 |
Training Training
Plan
- SOP for Training
- Performance of Training
|
| |
15.00 - 15.30 Discussion
of the Seminar |
