Expert GMP and GLP Training Courses
PharmOut offers tailored onsite GMP training courses to the pharmaceutical, veterinary, life science and medical device industries. Training teams together allows them to gain a practical understanding of GMP and how they apply it to their work.
Courses
These GMP and GLP courses are held on your site, to groups of up to 15 people. They include assessments and student handbooks.
Good Manufacturing Practice (GMP) Introduction
- Half day introductory course.
- GMP regulation in the Asian Pacific Region.
- History of GMP controls, GMP regulations and GMP audit procedures.
Good Manufacturing Practice (GMP) Introduction
- 1 day GMP training course.
- Implementation of current GMP regulations within a manufacturing environment.
- Ideal for manager, internal auditors and those with direct GMP responsibilities.
Good Laboratory Practice (GLP)
- 1 day training course.
- Implementation of current GLP standards within a laboratory.
Understanding and implementing ISO 13485:2003 Medical Devices - Quality Management Systems
- On-Site for 1-2 hours
- Ideal for the continuing professional development of managers, Quality and Operations staff.
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
This discusses how the TGA classifies GMP deficiencies found during audits. Numerous examples of typical GMP deficiencies and how to avoid them are given.
Use of Risk Management to help prevent labelling errors
A case study involving a detrimental label mix-up is used to show the importance of using risk management to help prevent label mix-ups.
Regulatory Requirements for Contract Manufacturing
A case study to illustrate how important it is to follow the requirements of Chapter 7 of the TGA & PIC/S GMP Guide, particularly in relation to the GMP agreement.
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