Where quality systems, microbiology, and data-driven thinking meet – translating complexity into clear, actionable outcomes.
The PIC/S Guide to Good Manufacturing Practice PE009-13 was published January 1, 2017. Edition 14 was published on 1 July, 2018.
The TGA adopted version 13 of the guide in 2018 and “just given” notice that it intends to adopt the current version of the PIC/S Guide (PE009-14) by July 1st 2020.
So you know what changes, if any you need to make to be in compliance with PE009-14, what are the key differences between these two guidance documents? Continue reading
Clear documentation is one of the most underrated technical skills within regulated manufacturing environments. Over the years I’ve written, reviewed, updated, and maintained large volumes of SOPs, work instructions, investigation reports, validation protocols, and controlled quality documents across pharmaceutical and food manufacturing operations.
As part of maintaining and refreshing those skills, I revisited Eliminating the Gobbledygook – Secrets to Writing Plain Language Procedures by Kathy Walsh, a book focused on practical plain-language documentation within Quality Management Systems. Continue reading
As of March 4 2020, 16 of the last 50 recalls by the FDA for pharmaceutical products were due to microbial contamination or a lack of sterility assurance. Another 27 were due to impurities with 5 more due to mislabeling. Looking at TGA recalls for 2019, around half of the medicine recalls due to contamination were the result of microbial contamination. Continue reading
As part of my job search, I tailor my resume and cover letter to match the requirements of the role being applied for.
An efficient way to do this is to have everything present in the source documents and then trim it down for the role.
Here is an iteration of my resume before tailoring. I do something similar for my cover letters. The important thing here once you have tailored your documents, let them sit for a day. That allows you (or at least me) to pick up on any errors and give the doccos a fresh proof read.
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Often there had been sufficient two way dialogue to negate the need to ask questions at the end of an interview. A lots of advice says not asking questions as the end of an interview is a cardinal sin. If the rapport had been good, the IMO there is no point. What I’ll do is state that everything was covering during our exchange and perhaps summarize a thing or two.
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