Do I receive a certificate after completing Good Clinical Practices (GCP) Audit and Inspection Readiness?

Yes, a certificate of completion is included with your registration.

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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.

4.8(0 reviews)

1.5 hours

Instructor

Charles H. Paul

President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence

Good Clinical Practices (GCP) Audit and Inspection Readiness

Quantity

Recording – 1 Viewer

$450.00

Buy Now

Secure payment via Stripe

Certificate of completion

What You'll Learn

Fundamental principles and guidelines of Good Clinical Practice (GCP)

Establishing a robust Quality Management System (QMS) for clinical trial compliance

Developing effective SOPs and documentation throughout the clinical trial lifecycle

Designing and conducting effective internal audits to identify non-compliance proactively

Personnel training strategies and maintaining ongoing GCP education

Practical tools for GCP audit and inspection readiness

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

GCP Principles, Regulatory Requirements, and Ethical Considerations

15 min

Building a QMS, SOPs, and Documentation Practices for Clinical Trials

15 min

Internal Audits — Design, Execution, and Proactive Issue Resolution

12 min

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.

30+ Years Regulatory ConsultingAdvanced Therapy GMP SpecialistSOP & Documentation ExpertLife Sciences Trainer & Author

Quantity

Recording – 1 Viewer

$450.00

Buy Now

Secure payment via Stripe

Certificate of completion

Event Details

Format

Recorded Webinar

Duration

1.5 hours

Certificate

Included

Access

Lifetime

Topics

GCP Clinical Trials Audit Readiness QMS SOPs FDA ICH Regulatory Compliance

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