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The A to Z’s of Microbial Control, Monitoring and Validation of Water Systems

Jan 25, 2012 | Comment (0) | Advertisement, validation-articles

All pharmaceutical, biologics, and medical device facilities are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. This course is designed to provide a microbiology-focused education about all aspects of water systems and how bio-film [...]

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COTS Software – 5 Essential Items to Consider

Jan 25, 2012 | Comment (0) | software-validation, validation-articles

COTS or Commerical Off-the-Shelf Software is commonly use in the life sciences today, but what are the pitfalls when it comes to validation of this software? Can you trust the vendor’s qualification and validation documentation or do you end up doing your own validation before you go-live. Below are some of the things you need [...]

Top Tips for Protocol Execution

Nov 9, 2009 | Comment (2) | software-validation, validation-articles

What should a test protocol contain? What is the typical content of a test protocol? Before any test execution takes place there are a number of checks you must do before entering into the world of test execution. “Fail to prepare, prepare to fail” no truer words can be spoken in relation to protocol execution. [...]

A Paperless Manufacturing Environment in 60 Days!

Jan 6, 2012 | Comment (6) | Advertisement

The guys at Kneat wondered why you couldn’t have a Paperless Quality Manufacturing System which was low cost, quick and easy to deploy and as easy as using Microsoft Word, but also had data integrity, control, security and audit trail capabilities required by cGMP manufacturing. So they spent 6 years creating it and Pharma people [...]

Good Manufacturing Practices (GMP) Discussion Group for Emerging Economies – Sign Up Today!

Jan 6, 2012 | Comment (2) | Advertisement, Groups

The team at AskaboutValidation are starting a new discussion group regarding various aspects of manufacturing to increase the awareness of global manufacturing competitiveness & regulatory concerns and issues faced by young and middle management executives in their profession specifically for emerging economies. Free Membership for the first 30 days This will be a free discussion [...]