GMP Authority Inspections Basics

GMP Authority Inspections Basics

Version 1.0

Released on 23/04/2022

An introduction to the audit process, feedback loops, behaviours and warnings along with consequences of audit failures.

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GMP Authority Inspections Basics

Version 1.0

Released on 23/04/2022

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Pharmuni certificate
GMP Authority Inspections Basics

Released on 23/04/2022

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  • Shareable certificate of completion

About the GMP Authority Inspections Basics

Every pharmaceutical manufacturer and certain service providers, who directly impact product quality or patient safety, are regularly audited by authorities. Pharmaceuticals companies take authority inspections and audits very seriously. These audits play a critical role in a company maintaining licences or their right to produce products. An authority can sometimes decide if a licence in a specific country is maintained or revoked. During this course you will be guided through the expected behaviours of an employee during and audit, what you can expect from the audit process, feedback loops and warnings along with consequences of audit failures.

TUV Certificate

ISO 9001

Quality Management System
Certificate Registration No.: 12 100 60610 TMS
Completion with

Pharmuni Certificate

Certificates issued by

Zamann Pharma Support GmbH

a TÜV-certified company in

Personnel qualification in the field of pharmacy, medical technology and quality assurance.

Consulting service in the field of pharmacy, medical technology and quality assurance.

Your Learning Objectives

This course has been desgined with learning objectives at the heart of it, so you can be assured to walk away with a valuable new knowledge set. After completing this course, you will be able to:

  • Learning Objective 1

    Grasp authority inspections are a key role in maintaining licenses.

  • Learning Objective 2

    Recognize poor audit results have serious consequences.

  • Learning Objective 3

    Learn audit planning, including surprise inspections.

  • Learning Objective 4

    Understand ideal employee behaviors during audits.

  • Learning Objective 5

    Interpret audit findings and address them effectively.

  • Learning Objective 6

    Master audit closing steps and corrective actions.

  • Learning Objective 7

    Differentiate FDA and EMA audit/warning processes.

Benefits of this Course

Get valuable resources, and ISO backed certification through our assessment of your knowledge and access global jobs only for Pharmuni alumni.

  • Downloadable Resources
  • Fast-Tracked Qualification
  • Exclusive Assessment Quiz
  • Skill Tree Levelup
  • Customer Support
  • Sharable & Downloadable Certification