Good Clinical Practices (GCP) Audit and Inspection Readiness
Build GCP audit and inspection readiness — cover QMS, SOPs, documentation, internal audits, and personnel training to ensure compliant clinical trial execution.
Instructor
Charles H. Paul
President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence
What You'll Learn
About the event
About this event
GCP audit and inspection readiness is a critical aspect of ensuring the integrity, quality, and compliance of clinical trials. Audits and inspections are conducted by regulatory authorities, sponsors, or independent entities to verify that trials are conducted in accordance with GCP standards and applicable regulatory requirements.
This webinar delves into GCP principles, building a strong foundation through robust QMS, SOPs, and documentation practices. It addresses the crucial role of personnel training, internal audit strategy, and practical tools for audit and inspection readiness.
By the end, participants will be equipped to contribute to the success of clinical trials, foster a culture of compliance, and navigate complex regulatory expectations with confidence.
Code: FDB3665
Curriculum
Requirements
- Clinical QA/QC, Compliance, and Regulatory Affairs professionals
- Applicable to clinical research associates, project managers, investigators, and study coordinators
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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