Why take this course?
FDA establishment inspections place facility behavior, documentation handling, and staff responses under direct review. Under the FD&C Act, FDA has authority to inspect drug and medical device manufacturing facilities and other regulated operations, with inspections occurring routinely or more frequently when circumstances warrant. For companies with significant historical violations, the likelihood and impact of inspection activity become even more pronounced.
Inspection outcomes are shaped not only by the condition of systems and records, but also by how personnel respond in real time. Interacting with FDA inspectors is not a natural workplace activity, and unstructured communication can influence how information is interpreted and how findings are formed. Truthfulness, knowledgeability, confidence, and disciplined conduct all affect the quality of the inspection exchange. This program organizes the inspection process from legal authority through facility interaction and documentation practices.
Key Areas Covered
Charles H. Paul
Charles H. Paul has spent more than 25 years leading a regulatory, training, and technical documentation consulting firm serving pharmaceutical, medical device, and biotechnology companies. His work centers on regulatory and operational performance, documentation systems, and training execution, making his background directly relevant to managing inspector interaction, staff conduct, and facility documentation during FDA inspections.
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