GMP Auditor Training (2 day)

The key to effective internal auditing of suppliers is the training of both auditors and auditees in the purpose and relevant techniques of the audit and how these techniques can be channelled to achieve business and compliance improvements.  It will cover Auditing Basics, Auditing Tools and Techniques, The Audit Process, Improving the Audit System, Added Value from Self Inspections (Level2 – QA Led).

 Day 1
Auditing Basics
 Reasons for audits and audit models (overview)
 The Purpose of Audits
 Role Characteristics of the Auditor
 Audit Types
 Audit Classification
 Audit Methods
 General Themes for All Audits

Auditing Tools and Techniques
 Basic tools
 Audit Techniques
 Audit Planning

DAY 2
The audit process
 Audit scheduling
 Conducting the audit
 Managing the Audit Team
 The Exit Meeting
 Audit Reporting
 Audit Closeout

Improving the audit system
 Adding Value from the Audit programme

Added Value from Self Inspections Level2 – QA Led)
 A practical Level 2 inspection programme
 (based on Auditor Training)
 Purpose of the self inspection programme
 Establishing the programme
 Setting up and training the inspection team
 Conducting the inspection and reporting

DR DAVID INGLIS is a consultant specialising in GMP/Quality Assurance
for the manufacturing sectors of the pharmaceutical and consumer healthcare
industry.

David has extensive experience in assessment and improvement of QA/GMP
systems, auditing, GMP training, inspection preparation and plant cleaning / decontamination,
especially in bulk intermediates and APIs. He has a Ph.D. degree in enzyme chemistry (affinity
chromatography).

http://pharma-training-courses.com/gmp-auditor-training.html