GMP Auditing

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Course Description:

This course will give you the basic principles of GMP auditing and give you the tools and know-how to conduct a GMP audit confidently.

 

GMP for Auditing is a step by step guide on how to audit a company’s GMP practices including:

  • How and what to prepare for the audit.
  • The audit protocol from the opening meeting to the closing feedback.
  • How to interview auditees for positive outcomes.
  • Aide-mémoire (memory aid) of each area that seasoned auditors use.
  • Classifying findings into critical, major, minor and examples.
  • Adding value to the company by paying attention to detail.

The course is broken down into modules to enable you to learn in bite sizes. At the end of each module, you may be required to complete a short quiz to ensure you have grasped the main points outlined in the module. 

The final assessment at the end of the course will test your overall understanding. The final assessment is an assignment that will need to be submitted and marked. Once it has been completed and passed, you will receive your Certificate of Competency. 

What you’ll need:

  • A good connection as this whole course is online.
  • Your notebook and pen to take notes as you learn.

Course Information

Estimated Time: 2 Days

Difficulty: Advanced

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Course Instructor

Peter Hannah Author
 

Once Off Payment

R4,250.00
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Introduction to GMP Auditing

Audits Have a Purpose
Company Responsibilities
Audits are Thorough
Who should be Audited?
GMP Auditing Course Overview
The Intro to GMP Auditing Quiz (Compulsory)

The FDA System

The FDA System Introduction
The 6 FDA Systems for Auditing
FDA Evaluation Focus Areas
Most Frequent FDA Findings from Audits
The FDA System Quiz (Compulsory)

The Audit Preparation

The Audit Preparation Introduction
Risk Assessment
The 80/20 Rule
How to Identify the 20% – Sterile Plant Example
How to Identify the 20% – Tablet Manufacturing Plant Example 
What to Prepare?
The Audit Preparation Quiz (Compulsory)

The Requirements of a GMP Auditor

The Requirements of a GMP Auditor Introduction
Interviewing
Listening
Observing
Recording
Analysing
The 5 Essential Skills of an Auditor Quiz (Compulsory)

Performing the Audit

Performing the Audit Introduction
Audit Tools
The Audit
Performing the Audit Quiz (Compulsory)

The Audit Protocol

The Audit Protocol
The Audit Protocol Quiz (Compulsory)

Audit Results 

Audit Results 
Audit Results Quiz (Compulsory)

Auditing a Companies Auditing Program

Auditing a Companies Auditing Program
Auditing an Audit Program Quiz

GMP Auditing Course Summary

GMP Auditing Course Summary

Final Assessment

Auditing to GMP Final Assessment Workshop (Compulsory)
GMP Auditing Feedback

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