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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.

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1.5 hours

Instructor

Charles H. Paul

President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence

FDA Inspection Readiness: Building a Defensible State of Control Before the Investigator Arrives

Quantity

Recording – 1 Viewer

$398.00

Buy Now

Secure payment via Stripe

Certificate of completion

What You'll Learn

FDA's risk-based inspection approach under the FDA Site Selection Model

How FDA uses registration data, submissions, recalls, and prior history

Difference between routine surveillance and for-cause inspections

What FDA means by 'inspection ready' — continuous state of control

FDA data signals that drive inspection focus: CAPA, OOS/OOT, complaints

Management accountability and executive oversight expectations under FDA scrutiny

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

FDA's Risk-Based Inspection Approach and Site Selection Model

12 min

What FDA Means by 'Inspection Ready' — Continuous State of Control

12 min

FDA Data Signals That Drive Inspection Focus

12 min

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.

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

Quantity

Recording – 1 Viewer

$398.00

Buy Now

Secure payment via Stripe

Certificate of completion

Event Details

Format

Recorded Webinar

Duration

1.5 hours

Certificate

Included

Access

Lifetime

Topics

FDA Inspection Inspection Readiness GMP 21 CFR 211 21 CFR 820 CAPA QSIT Risk-Based

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