Day 1 Agenda

 

8:30 a.m. | Welcome and Introductions


Angela Buzard
, Manager, Training and Development, K-State Olathe

Norm Brown, Instructor, K‐State Olathe

Helen Smith, Director, Regulatory Affairs, Ceva Biomune

Terrie Jo Hamtak, Director of Quality, Merck Animal Health


8:45 a.m. | Introduction to Advanced Biologics (Helen Smith and Norm Brown)

  • Basis for USDA Regulatory overview
  • What products fall under USDA Regulatory Oversight
  • Navigating the USDA website


9:45 a.m. | Break

 

10 a.m. | Registration of a Vaccine (Helen Smith)

  • 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


Noon | Lunch

 

 

12:30 p.m. | Registration of a Vaccine Continued (Helen Smith)

  • Additional Safety Studies for live GMO
  • Field Safety
  • Validation of Sterility (Dilution of Preservatives)
  • Study Summaries
  • Labels
  • Strategies for managing set-backs during the licensing procedure

 

1 p.m. | Other Registration Considerations

  • Advertising and promotional material
  • Specialty Biologicals

 

1:45 p.m. | Break

 

2 p.m. | Introduction to Quality Management Systems (Terrie Jo Hamtak)

  • Definitions
  • Aspects of good quality management systems
  • Change control


2:45 p.m. | Compliance Policy for Issuing Regulatory Actions (Terrie Jo Hamtak)

  • Problem with released serials
  • Communication with CVB
  • Firm actions
  • Regulatory actions

 

4:15 p.m. | Wrap‐up and Concluding Remarks
Norm Brown, Instructor, K‐State Olathe

 

4:30 p.m. | Adjourn