Home/Catalog/Deviations, CAPA and Change Control
← Back to Catalog
Recorded WebinarNew

Deviations, CAPA and Change Control

Move beyond superficial root causes — build defensible deviation reports, sustainable CAPA, and change control aligned with 21 CFR 820.100 and GMP expectations.

4.9(0 reviews)
1.5 hours
Charles H. Paul

Instructor

Charles H. Paul

President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence

What You'll Learn

Deviation and nonconformance management best practices
Root cause analysis methods and writing defensible investigations
CAPA effectiveness, sustainability, and risk assessment tools
Change control requirements aligned with 21 CFR 820.100
Trending, metrics, and continuous improvement strategies
Maintaining long-term inspection readiness through mature quality oversight

About This Event

This course tackles one of the most critical inspection triggers: weak investigations. It teaches how to move beyond superficial root causes and build defensible deviation reports supported by evidence. Participants learn structured root cause analysis, sustainable CAPA development, and effective change control aligned to 21 CFR 820.100 principles. The focus is on long-term system strength — trending, metrics, and risk-based thinking that prevent repeat issues. By strengthening deviation handling and CAPA effectiveness, organizations significantly reduce repeat findings and demonstrate mature quality oversight. This is Module 4 of the Practitioner Course "GMP Master Class for Life Sciences." Code: SEM37664

Curriculum

Deviation and Nonconformance Management
12 min
Root Cause Analysis Methods and Writing Defensible Investigations
15 min
CAPA Effectiveness and Sustainability
12 min

Requirements

  • QA, QC, Manufacturing, Regulatory Affairs, or Engineering professionals
  • Applicable to CAPA coordinators, change control managers, and compliance teams

Meet Your Instructor

Charles H. Paul

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
1

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

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.

Dr. Ginette CollazoDr. Ginette Collazo
1.5 hoursJun 30, 2026
4.8
$190.00$250.00
View Details
HPLC Analytical Method Development and Validation
Live WebinarNew
Regulatory & ComplianceCertificate

HPLC Analytical Method Development and Validation

Master HPLC instrument and method validation to meet US EPA and FDA requirements for pharmaceutical analysis.

Dr. John C. FetzerDr. John C. Fetzer
1 hourJun 17, 2026
4.8
$145.00
View Details
ChatGPT-Assisted Technical Writing
Live WebinarNew
Regulatory & ComplianceCertificate

ChatGPT-Assisted Technical Writing

Learn practical, compliant approaches to using ChatGPT for SOP drafting, document development, and technical writing in regulated industries.

Charles H. PaulCharles H. Paul
1 hourJun 24, 2026
4.9
$190.00
View Details