Day 2 Agenda
8:30 a.m. | Licensed Facilities continued
Terrie Jo Hamtak, Director of Quality, Merck Animal Health
- Other facility aspects
- Maintenance and review
- CVB Inspection and observation
10 a.m. | Break
10:15 a.m. | Release Process of Marketable Batches
Terrie Jo Hamtak, Director of Quality, Merck Animal Health
- Manufacturing deviations
- APHIS Form 2008
- CVB review
- Release process
Noon | Lunch
12:30 p.m. | Release Process of Marketable Batches continued
Terrie Jo Hamtak, Director of Quality, Merck Animal Health
1 p.m. | USDA Government Samples
Terrie Jo Hamtak, Director of Quality, Merck Animal Health
- Firm sample selection
- Exceptions to the rule
- Labeling and shipping samples
- Numbers of samples
- Sample testing
1:30 p.m. | Continuing Compliance After Licensure
Norm Brown, Instructor, K‐State Olathe
- Labelling
- Outline of Production – Annual Outline Review
- Pharmacovigilance
- 2007s
2 p.m. | Break
2:15 p.m. | Policy for Issuing Regulatory Actions
Terrie Jo Hamtak, Director of Quality, Merck Animal Health
- Problem with released serials
- Communication with CVB
- Firm actions
- Regulatory actions
3 p.m. | In-Depth Inspections
Terrie Jo Hamtak, Director of Quality, Merck Animal Health
- Background
- Administrative Inspection Review
- Inspection types and categories
- Inspectors role
- Categories 1 to 14
- Inspection Checklist
- Violations
4:15 p.m. | Wrap‐up and Concluding Remarks
4:30 p.m. | Adjourn