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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)


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