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Whitepaper - How to implement good documentation practices.
PharmOut is an international GMP consultancy of over 75 professionals serving the Pharmaceutical, Medical Device and Veterinary industries. PharmOut specialises in PIC/S, WHO, United States FDA, European EMA, and Australian TGA GMP consulting, engineering, project management, training, validation, continuous improvement and regulatory services.
Our team includes international GMP experts who have previously held leadership roles within regulatory bodies.
PharmOut’s team offers practical, hands-on GMP guidance. We only recruit experienced Life Science professionals with a genuine passion for quality. We consult and train on regulatory GMP compliance, product registration, validation and continuous improvement of manufacturing processes. More
Our pharmaceutical validation consulting services include - equipment validation, cleaning validation and Computer Systems validation as well as Pharmaceutical and Medical Device Process Validation to PIC/S, GHTF, EMA, FDA and TGA regulations.
We have many experienced Computer Systems Validation consultants within our GMP consultancy who can advise on FDA 21 CFR Part 11 and TGA Annex 11 regulations. More
We offer a professional engineering design and project management service to the pharmaceutical, biopharmaceutical, veterinary and medical device industries. This encompasses facility, service, process and automation design, complementing and supporting our GMP and validation expertise. More
Your Quality Management System (QMS) is the first place a GMP auditor will ask to see when they visit your site. The key to good documentation is to “say what you do and do what you say.” Your QMS must document the processes used in your facility, you need to ensure your staff are trained and follow your documented procedures. More
Our GMP consultancy also offers GMP training for the Pharmaceutical, Medical Device & other Life Science industries, including basic GMP training, GAMP 5 training, ISO 13485 training and Q9 / ISO 14971 quality risk management training courses. More
Online training courses for general GMP and PIC/S GMP including all the Annexes have been developed in conjunction with Bob Tribe, past PIC/S chairman. The courses are excellent tools to ensure compliance training if you are having inspections from the TGA, HSA, FDA, EMEA or IMB. More
New discount bundles available with courses starting from $25