FDA Inspection Readiness: Building a Defensible State of Control Before the Investigator Arrives
Understand how FDA selects inspection targets, evaluates quality systems remotely, and build a continuous state of control aligned with 21 CFR regulations before the investigator arrives.
Instructor
Charles H. Paul
President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence
What You'll Learn
About the event
About this event
This course concentrates on pre-inspection readiness — what FDA evaluates long before the investigator presents FDA Form 482. Participants explore the FDA's risk-based inspection philosophy, including how internal Agency models prioritize sites for inspection and how seemingly minor data inconsistencies can elevate inspection scope.
The session examines what FDA truly means by being "inspection ready," emphasizing the difference between having procedures in place and demonstrating real-world process control. Special attention is given to documentation practices, investigation quality, CAPA effectiveness, and management oversight.
This is Module 1 of the Practitioner Course "FDA Inspection Readiness — Modular Course for Practitioners."
Code: SEM37641
Curriculum
Requirements
- QA, Regulatory Affairs, Compliance, Manufacturing, and Operations professionals
- Applicable to validation managers, laboratory managers, CAPA program owners, and site leadership
Meet Your Instructor
Charles H. Paul
President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence
Charles H. Paul is President of CHP Consulting LLC, a regulatory compliance, operational excellence, training, and technical documentation consulting firm supporting pharmaceutical, biotechnology, medical device, and advanced therapy organizations worldwide. With more than 30 years of experience in regulated manufacturing environments, Charles specializes in helping organizations build sustainable quality systems that support compliance, operational performance, workforce effectiveness, and inspection readiness. His experience includes GMP quality systems, manufacturing operations, technical training development, process validation, deviation management, CAPA systems, operational excellence, documentation systems, and regulatory inspection preparation. Charles has supported organizations implementing new technologies, expanding manufacturing operations, establishing quality infrastructures, and preparing for complex regulatory inspections. He is a recognized author, speaker, and consultant who has delivered numerous webinars and seminars on GMP compliance, quality systems, human performance improvement, technical documentation, inspection readiness, and operational excellence throughout the life sciences industry.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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