On site High Impact Professional Development Series
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 relevant to your operations during the session and reach a common understanding.
To book a presentation, contact us. for details and customisation.
Educational sessions delivered by Bob Tribe
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.
Common TGA and FDA 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.
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