JVT Journal Articles
Vol. 22, Issue 1, Feb 2016

Deirdre O'Keeffe
,
Cliff Campbell
,
Kevin O’Donnell
This paper challenges the current approach to classifying process parameters and quality attributes as being critical or non-critical. It discusses how this binary approach is probably overly simplistic, and that it may not adequately reflect science and risk-based thinking. The problems presented by defective medicines and product recalls are...
Ivan Soto
The recent FDA guidance document on analytical methods and validation is discussed. Key points in specific sections including Analytical Methods Development, Content of Analytical Procedures, Analytical Method Validation, Lifecycle Management of Analytical Procedures, and FDA Methods Verification are described. In order to assess company...
Roberta Goode
Voted one of IVT Network's best presenters of 2015, Roberta Goode shares her polished expertise and knowledge in this exclusive presentation at our 21st Annual Validation Week. In this packed-house talk, Ms. Goode gives a thorough treatment for the validation and production of packaging and shipping, going over regulations in the U.S. and...
Tim Sandle
Auditing is a vital function within the pharmaceutical and healthcare sectors. Audits provide the mechanism to assess the level of compliance and provide an indication of problems that might lead to product adulteration or patient harm. Key areas for the audit process are listed. Relevant audit topics discussed include audit planning, vertical and...
Ed Maio
In the quest to determine why a deviation has occurred, there are many roadblocks that can keep the problem from being solved. Time constraints that force the investigator to move quickly through the problem-solving process, investigators who are overwhelmed with other responsibilities besides solving the problem, and management’s reluctance to...

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