Day 2 Agenda

 

8:30 a.m. | Welcome and Recap
Norm Brown, Instructor, K‐State Olathe

 

8:45 a.m. | Licensed Facilities (Terrie Jo Hamtak)

  • Definitions
  • Plot plans, blueprints and legends
  • Building construction
  • Other facility aspects
  • Maintenance and review
  • CVB Inspection and Observation

 

10 a.m. | Break

 

11 a.m. | Release Process of Marketable Batches (Terrie Jo Hamtak)

  • Definitions
  • Manufacturing deviations
  • APHIS Form 2008
  • CVB review
  • Release process

Noon | Lunch

 

12:30 p.m. | USDA Government Samples (Terrie Jo Hamtak)

  • Firm sample selection
  • Exceptions to the rule
  • Labeling and shipping samples
  • Numbers of samples
  • Sample testing


1 p.m. | Continuing Compliance After Licensure (Helen Smith)

  • Labelling
  • Outline of Production – Annual Outline Review
  • Pharmacovigilance
  • 2007s


1:30 p.m. | In-Depth Inspections (Terri Jo Hamtak)

  • Background
  • Administrative Inspection Review
  • Inspection types and categories
  • Inspectors role
  • Categories A to N
  • Inspection Checklist
  • Violations


2 p.m. | Break

 

3:15 p.m. | Root Cause Investigations (Terrie Jo Hamtak)

  • Guidelines
  • Quality Risk Analysis
  • Procedure in place at the firm to address deviations/excursions
  • Product Risk Analysis
  • Root Cause Investigation
  • Review of similar products/processes
  • Address other sites, if applicable
  • Corrective Action and Preventative Action (CAPA)
  • CAPA Effectiveness


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

 

4:30 p.m. | Adjourn