Internal GMP Audit & Role of GMP Auditor

gmp audit and auditor role

Duration :


1 hour(s)

Skill level:




Final exam:


Certificate of Completion:


CEU / CPD Accreditation:



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 ourย certificate online checker. They can also be shared on Linkedin.


Elevate Your Auditing Expertise with Our Comprehensive Course on Internal GMP Audits & The Role of GMP Auditor.

Navigate the complex landscape of FDA and EMA regulations with confidence by mastering the art of internal GMP audits. This crucial internal review system is the cornerstone of quality, consistency, and safety in the life sciences sector.

Whether you’re part of a life sciences organization preparing for internal audits, or an auditor aiming to streamline audit activities, this course provides the essential skills and knowledge you need. Make informed decisions, foster continuous improvement, and ensure your organization’s success in regulatory inspections.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.




Lesson 1: Introduction to GMP Audit

  • What is a GMP audit ?
  • Why are audits important ?
  • Who is an auditor ?
  • GMP Principles for Auditors


Lesson 2: GMP Audit Process

  • Step 1 : Planning
  • Step 2 : Conducting the audit
  • Step 3 : Creating, Approving, and Distributing the Audit Report
  • Step 4 : Conclusion


Lesson 3: System Based Approach for Internal Audit


Lesson 4: Lesson 4: Role of GMP Auditor

  • How to be a competent auditor ?






Dr. Ciaran McEnister
Senior Pharmaceutical Executive with 25+ years of experience in medical device development. Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager.


USD: United States (US) dollar ($) ^


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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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$60.00 / year

$60.00 / year

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