Day 1 Agenda
8:30 a.m. | Introduction to Advanced Biologics
Norm Brown, Instructor, K‐State Olathe
Helen Smith, Director, Regulatory Affairs, Ceva Biomune
- Basis for USDA Regulatory overview
- What products fall under USDA Regulatory Oversight
- Navigating the USDA website
9:45 a.m. | Break
9:55 a.m. | Registration of a Vaccine
Helen Smith, Director, Regulatory Affairs, Ceva Biomune
- Master seed/Cell preparation and testing
- Efficacy
- Ingredients of animal origin and raw materials
- Outline of production
- Potency Assay
- Inactivation Kinetics
- Laboratory Safety for Modified Live Vaccines
- Conditional licenses and state registrations
11:55 a.m. | Break
12:05 p.m. | Registration of a Vaccine Continued
Helen Smith, Director, Regulatory Affairs, Ceva Biomune
- Additional Safety Studies for live GMO
- Field Safety
- Validation of Sterility (Dilution of Preservatives)
- Study Summaries
- Labels
- Strategies for managing setbacks during the licensing procedure
12:30 p.m. | Other Registration Considerations
Helen Smith, Director, Regulatory Affairs, Ceva Biomune
- Advertising and promotional material
- Specialty Biologicals
1 p.m. | Lunch
2 p.m. | Introduction to Quality Management Systems
Terrie Jo Hamtak, Director of Quality, Merck Animal Health
- Definitions
- Aspects of good quality management systems
2:25 p.m. | Data Integrity
Terrie Jo Hamtak, Director of Quality, Merck Animal Health
- ALCOA
- 9CFR and data integrity
2:40 p.m. | Break
2:50 p.m. | Change Control
Terrie Jo Hamtak, Director of Quality, Merck Animal Health
- Change impacts
- Types of change
3:45 p.m. | Licensed Facilities
Terrie Jo Hamtak, Director of Quality, Merck Animal Health
- Plot plans, blueprints and legends
- Building construction
4:20 p.m. | Wrap‐up and Concluding Remarks
4:30 p.m. | Adjourn