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CSV and IT Compliance Training

“We have just concluded several regional training sessions with Sion Wyn on IT compliance and Computer System Validation for the drug, device and vet industries. The course curriculum was developed with industry representatives to …

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The Real Value of a Cleanroom

Cleanrooms have been part of Life Science manufacturing for a long time, for example a device, pharmaceutical or a pharmacy clean room all have specific design requirements to make sure that they add value. …

Product Quality Reviews – The Right Approach

Quality Management Systems (QMS), be it ISO or PIC/S, mandate that system reviews must occur. Product Quality Reviews (PQR) can provide the ideal platform not solely to fulfill a compliance requirement but to give …

Cultural Change Methodology as a Competency

Why do we resist change? What does this mean in our regulated environment?
Ever wondered why the same errors happen in your regulated facility?
Or why the most experienced operators continue to make the same mistakes?
Do …

TGA to revise guides for complementary medicines

The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) was first published in 2001 to provide information on the supply and use of complementary medicines. The TGA is currently reviewing and restructuring the guidelines for …