| 08.30 -
09.00 |
Welcome &
Introduction |
| 09.00 -
10.00 |
Good
Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
What is the difference, which to apply to a validation study and
when. |
| 10.00 -
10.45 |
Validation Guidelines:
- Pharmacopoeias
- ICH
- Regulatory agencies FDA/MHRA
- Industry e.g. PDA Technical report 33.
|
| 10.45 -
11.15 |
Coffee |
| 11.15 -
12.15 |
What are
the Requirements for an Internal Validation Study?
- Elements of the
validation:
- Design qualification (DQ) definition/documentation
- Installation qualification (IQ) definition/assistance
- Responsibility is very often delegated to the supplier for DQ and
IQ
- Operational Qualification (OQ) definition/proof of principle
- Performance Qualification (PQ) definition/how far to go
|
| 12.15 -
13.00 |
- The
validation protocol
- Re-sourcing and execution of the validation
study
- The Validation report
- SOP's and documentation
- Regulatory submissions
- Implementation and change control
|
| 13.00 -
14.00 |
Lunch |
| 14.00 -
15.00 |
Audits
- Regulatory audits FDA, 3 types of audit
- MHRA and other European agencies
- Customer audits
- What are the auditors looking for?
- How are audits structured?
|
| 15.00 -
15.30 |
Tea |
| 15.30 -
16.15 |
Data
security, accessibility and ease of tracking and trending GMP
Failures and Warning Letters |
| 16.15 -
16.45 |
Recent
experiences with regulator inspections on the Validation and
implementation of MicroSeq. FDA 483 citation MHRA comments. |
| 16.45 -
17.00 |
Final
Discussion Round |
