How much does GMP 101 and Inspection Readiness cost?

Registration options: Recording – 1 Viewer: $398; Recording – Unlimited Viewers: $1294.

Do I receive a certificate after completing GMP 101 and Inspection Readiness?

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

Home/Catalog/GMP 101 and Inspection Readiness

Recorded WebinarNew

GMP 101 and Inspection Readiness

Establish the mindset for modern GMP compliance — understand how FDA inspects, why documentation gaps become findings, and how to build inspection-ready systems.

4.9(0 reviews)

1.5 hours

Instructor

Charles H. Paul

President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence

Quantity

Recording – 1 Viewer

$398.00

Buy Now

Secure payment via Stripe

Certificate of completion

What You'll Learn

FDA GMP framework under 21 CFR Parts 210, 211 & 820

How FDA conducts inspections and gathers evidence

Understanding Form 483 observations and Warning Letters

Quality ownership and defined roles and responsibilities

Designing inspection-ready quality systems

Building defensible documentation practices and a sustainable culture of compliance

About This Event

This course establishes the mindset shift required for modern GMP compliance. It explains how FDA interprets 21 CFR 210, 211, and 820 during inspections and how evidence is gathered to support observations. Participants learn why minor documentation gaps become major findings and how to design systems that demonstrate control rather than merely claim it. The focus is on ownership, accountability, and inspection psychology. By understanding how investigators evaluate systems, teams can proactively strengthen documentation, clarify roles, and embed readiness into routine operations instead of scrambling before audits. This is Module 1 of the Practitioner Course "GMP Master Class for Life Sciences." Code: SEM37661

Curriculum

FDA GMP Framework: 21 CFR Parts 210, 211 & 820

12 min

How FDA Conducts Inspections and Gathers Evidence

12 min

Form 483 Observations and Warning Letters — What They Signal

12 min

Requirements

QA, QC, Manufacturing, Regulatory Affairs, or Compliance professionals in life sciences
Applicable to validation professionals, engineers, training managers, and document control personnel

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

GMP FDA Inspection Readiness 21 CFR 210 21 CFR 211 21 CFR 820 Form 483 Warning Letters

Related Events

AI in GMP: What the FDA Is Already Expecting - Before You Ask

Live WebinarNew-24%

Regulatory & ComplianceCertificate

AI in GMP: What the FDA Is Already Expecting - Before You Ask

FDA already expects GMP compliance for AI systems. Learn how existing validation, data integrity, and oversight rules apply—before regulators come calling.