GMP, GLP Training

PharmOut offers tailored onsite GMP training courses to the pharmaceutical, life science and medical device industries. Training teams together allows them to consider real-life issues during the session and reach a common understanding.

Courses

These GMP and GLP training courses are held on your site, to groups of up to 15 people. They include assessment and student handbooks.

Good Manufacturing Practice (GMP) - Introduction

This half day introductory GMP training course covers how GMP is regulated in South Africa, the history of GMP controls, GMP regulations, GMP audit procedure, control of overseas manufacturers. Ideal for staff who are not directly responsible for GMP activities but need to know how the regulations impact on business operations.

Good Manufacturing Practice (GMP)

1 day GMP training course covers the practical implementation of current GMP regulations within a manufacturing environment producing product for both the South African and FDA markets. Ideal for managers, internal audits and those with direct GMP responsibilities.

Good Laboratory Practice (GLP)

1 day GLP training course covers the practical implementation of current GLP standards within a laboratory and allows attendees ask tough practical questions regarding GLP at work in a laboratory.

Understanding and implementing ISO 13485:2003 Medical devices - Quality Management Systems.

1 day ISO 13485 training course teaches practical and affordable approaches to compliance with this standard.

Learn how to avoid common mistakes and which parts of the standard to focus on according to their operational needs.

Educational sessions

These sessions are ideal for the continuing professional development of managers, Quality staff and Operations staff. They are conducted on your site and typically take 1-2 hours. They may be presented to larger audiences.

TGA and PIC/S auditing procedures

How a TGA / PIC/S GMP audit is carried out, from planning to opening meeting to closing meeting to close out.

Tips on preparing for TGA and PIC/S audits

How to prepare for and handle a regulatory audit done by a TGA or PIC/S inspectorate.

GMP deficiencies

How the TGA classifies GMP deficiencies identified during audits. Includes many examples of typical GMP deficiencies and how to avoid them.

Use of risk management to help prevent labelling errors

A case study involving a serious label mix-up is used to illustrate the importance of using risk management to help prevent label mix-ups.

Regulatory requirements for contract manufacturing

A case study to highlight the importance of following the requirements of Chapter 7 of the TGA & PIC/S GMP Guide, particularly in relation to the GMP agreement.