Select Topics for On-Site Training

Good Manufacturing Practices (GMPs)

A-01. GMP Compliance

A-02. GMP Interpretations

A-03. GMP Documentation and SOP Requirements

A-04. GMP Requirements for Sterile Products

A-09. GMPs for Active Pharmaceutical Ingredients: A Comparative Review

A-10. GMP for Executive Management

A-15. U.S. vs. Barr Laboratories

A-16. GMP Requirements for Calibration and Maintenance

A-20. GMP Requirements for Buildings and Utilities

A-24. Compliance Review for Change Control Program

A-25. Aseptic Techniques

A-27. GMP Compliance issues for Aseptic Processing

A-29: Data Integrity

E-09. FDA Compliance/Inspection Trends and Issues (within previous two yeas)

Clinical Supplies and Research & Development

A-06. GMP Requiements and Compliance Issues for Clinical Supplies

A-11. Development and Technology Transfer Reports

A-19. Good Documentation Practice and Compliance Review for Research & Development

Part 11 and Other FDA GMP Initiatives

A-23. Electronic Records and Electronic Signatures

A-28. Part 11 Guidance - Electronic Records and Signatures

FDA Inspections

E-08. FDA Inspections: Dos and Don'ts

E-10. Preparation for an FDA Pre-Approval Inspection (PAI)