Conducting Internal GMP/QSR/GCP/GLP Investigations
8:30 a.m. – 9:00 a.m. |
Continental Breakfast |
9:00 a.m. – 10:15 a.m. |
Individual Liability and the Park Doctrine
Exercise — Case Studies Involving Application of the Park Doctrine
|
10:15 a.m. – 10:30 a.m. |
BREAK |
10:30 a.m. – 12:00 p.m. |
We Know What Happened, Now What?
Exercise — Reports to Senior Management and Audit Committees |
12:00 p.m. – 1:00 p.m. |
LUNCH |
1:00 p.m. – 2:30 p.m. |
Building a Culture of Compliance: It Starts at the Top
Exercise — Developing a Corrective Action Plan |
2:30 p.m. – 2:45 p.m. |
BREAK |
2:45 p.m. – 4:00 p.m. |
Exercise — Liability for GMP/QSR/GCP/GLP Violations (Case Studies) |
4:00 p.m. – 4:30 p.m. |
Wrap Up – Best Practices |
4:30 p.m. |
ADJOURN DAY 2 |
Who will benefit?
If your company manufactures drugs or biologics, devices or diagnostics, conducts clinical trials or runs laboratory operations or is a contract or component manufacturer – or if you serve such firms as a lawyer or consultant – this workshop is for you. Here are just a few of the many executives who can benefit –
- Executive management
- General/corporate counsel
- Manufacturing directors and supervisors
- Clinical directors and supervisors
- Laboratory directors and supervisors
- Internal compliance directors and supervisors
- Regulatory/legal affairs professionals
- Data management and statistics personnel
- Engineering and design controls teams
- Risk management specialists
- Auditors and investigators
- QA/QC personnel
- R&D staff
- Training personnel
- Validation specialists, scientists, engineers
- Personnel new to the industry