DRUGS

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Course Name	Duration	Time
Major cGMP Compliance Courses		9:00am - 12:00pm 1:00pm - 4:00pm
Preparing, Participating & Handling a CFDA Inspection	3 days
FDA cGMP Compliance for Drug Products: Interpretation & Application	3 days
FDA cGMP Compliance for APIs: Interpretation and Application	3 days
FDA cGMP Compliance: Laboratory Controls	2 days
FDA cGMP Compliance: Batch Record Review & Investigations	2 days
FDA cGMP Compliance: Qualification and Validation	2 days
FDA cGMP Compliance: Auditing	2 days
FDA cGMP Compliance: Auditing (Sterile Pharmaceuticals)	3 days
Computer System Validation and Part 11	3 days
Other cGMP Compliance Courses
FDA cGMP Requirement: Buildings and Utilities	0.5 day
FDA cGMP Requirement: Development and Technology Transfer Reports	0.5 day
FDA cGMP Requirement: Documentation and SOPs	0.5 day
FDA cGMP Requirement: Change Control	0.5 day
FDA cGMP Requirement: Maintenance and Calibration	0.5 day
FDA cGMP Requirement: Product Annual Review	0.5 day
FDA cGMP Requirement: Label and Labeling Controls	0.5 day
FDA cGMP Requirement: Acceptance Criteria for Cleaning Validation	0.5 day
FDA International Inspection Program	0.5 day
Preparing for an FDA Pre-approval Inspection (PAI)	0.5 day
Preparation for and Handling of FDA Inspections	0.5 day
Other Courses
FDA Application Regulations: New Drugs and Generic Drugs	2 days
FDA Application Regulations: APIs	2 days
FDA cGLP Compliance: Interpretation and Application	2 days
FDA cGCP Compliance: Interpretation and Application	2 days
FDA: Design and Analysis of Clinical Trials	3 days
FDA: Fundamentals of Health Economics and Outcomes Research	2 days