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Regulatory Compliance Inspections and External Audits

Rated 4.5 out of 5

53

Duration :

2

2 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course :

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

Regulatory inspections by the FDA and WHO are a defining test of any GMP-compliant operation. This course provides a practical overview of how inspections and external audits work, what inspectors look for, and how to build sustainable inspection readiness across your quality systems.

Developed by Regulatory Affairs experts trained at Northeastern University and guided by a senior industry specialist, the course delivers a clear, practical overview of inspection readiness.

Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

Who should enroll?

Quality Assurance and Quality Control professionals
Regulatory Affairs and compliance specialists
Manufacturing and operations teams
GMP audit and inspection readiness personnel

What you’ll learn?

Understand the purpose of regulatory inspections and external audits in GMP environments
Identify the agencies responsible for monitoring compliance (FDA, WHO)
Recognize the different types of inspections and what each evaluates
Prepare for FDA inspection expectations across key quality systems
Strengthen inspection readiness and support continuous GMP compliance

Curriculum

Introduction

Lesson 1: Why are Regulatory Compliance Inspections and External Audits Important?

Lesson 2: The ICH Q10 Guidelines on Regulatory Inspections

Achieve Products Realization
Establish and Maintain a State of Control
Facilitate Continual Improvement

Lesson 3: Which Businesses are Subject to Compliance Inspections and External Audits?

Lesson 4: Who Monitors and Audits GMP Compliance?

Regulatory agencies responsible for GMP Audits

Lesson 5: Types of Regulatory Compliance Inspections

Routine Inspection
Concise Inspection
Follow-up Inspection
Special Inspection
Quality Systems Review
Frequency of Inspections

Lesson 6: FDA Guidelines for Compliance Inspection and Audit Strategy

Quality system
Inspection of Quality System (Phase 1 and Phase 2)
Product Reviews
Compliant Reviews
Discrepancy and Failure Investigations (for manufacturing and testing)
Change Control
Product Improvement Projects

Glossary

Quiz

Author:

Dr. Jefferson

Dr. Jefferson is a CAPA Manager. She serves as a Training and Quality Advisor with ICONIC plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Dr. Jefferson is a fixer who continuously strives for excellence as a way of life; not just as a job.

Reviews:

Rated 4.5 out of 5

53

My team gained sufficient knowledge to maintain perpetual readiness for inspections and audits in the facility. We owe it all to GxP Training!

$89

Participant(s):

Buy now

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This course includes:

One-year access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
Instant Purchase : one click to buy and immediate access. Get certified today.
LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.