Conducting Internal GMP/QSR/GCP/GLP Investigations
8:00 a.m. – 9:00 a.m. |
Registration and Continental Breakfast |
9:00 a.m. – 9:30 a.m. |
Whistleblower Allegations in a GMP/QSR/GCP/GLP Environment
|
9:30 a.m. – 10:15 a.m. |
Overview of Whistleblower Protections/Increased Government Oversight of Corporate Conduct |
10:15 a.m. – 10:30 a.m. |
BREAK |
10:30 a.m. – 12:00 p.m. |
Do We Investigate?
Exercise — Evaluation of Hotline Complaint and Recommendations for Next Steps |
12:00 p.m. – 1:00 p.m. |
LUNCH |
1:00 p.m. – 2:30 p.m. |
What Is Our Plan?
Exercise — Developing the Investigation Plan |
2:30 p.m. – 2:45 p.m. |
BREAK |
2:45 p.m. – 4:30 p.m. |
Conducting the Internal Investigation
Exercise — Best Practices For Witness Interviews
|
4:30 p.m. |
ADJOURN DAY 1 |
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