About Course
Understand GMP inspections from both sides of the table. This course explains inspection principles, types and approaches, how inspectors think and how an inspection unfolds. You will design and run an effective self-inspection programme, report and score findings, and audit contract manufacturers, suppliers and API manufacturers. Dedicated modules cover the FDA approach and focus areas, preparing content and addressing known weaknesses, organisational preparation, behaviour and communication in the inspection room, handling observations and responses, and sustaining inspection readiness. A final assessment and a certificate of completion are included.
Course Content
Module 1: Inspection Principles and Types
Module 2: Inspection Approaches
Module 3: The Inspector
Module 4: Anatomy of an Inspection
Module 5: Self-Inspection Programme Design
Module 6: Conducting Self-Inspections
Module 7: Reporting, Scoring and Evaluation
Module 8: Auditing Contract Manufacturers
Module 9: Auditing Suppliers
Module 10: Auditing API Manufacturers
Module 11: FDA Approach and Focus Areas
Module 12: Inspection Content Preparation and Known Weaknesses
Module 13: Organisational Preparation
Module 14: Behaviour and Communication During Inspections
Module 15: Observations, Responses and Outcomes
Module 16: Sustained Inspection Readiness
Final Assessment
Earn a certificate
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