Monthly Archives: March 2016

Use of Detectability In Risk Assessments

ValSource announced Quality Risk Management and Microbiology Consultant Amanda Bishop McFarland has been published by the Institute of Validation Technology (“IVT”) Network. IVT Network is a trusted source for life science validation and compliance professionals to access the most current and relevant industry and regulatory knowledge. McFarland’s article, “Considerations Regarding the Use of Detectability In Risk Assessments,” explores potential pitfalls associated with considering detectability within the risk management framework.

“The purpose of considering detection in any scenario is to ensure that potential or actual failures can be identified with enough time to take action before the user is adversely affected,” she said….

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Line-of-Sight Technique Illuminates Dark Corner—Shipping Validation

ValSource announced, Senior Validation and Risk Consultant Christopher M. Hanff is leading efforts to address what he and his colleagues have identified as critical Active Transport Validation needs and deficiencies within the pharmaceutical, biotechnology and medical device industries.

Speaking to engaged and receptive audiences, Hanff recently addressed Interphex Puerto Rico, PDA, and several other venues on the topic. “Shipping and its validation remain largely undervalued and highly misunderstood.” Hanff continued, “It’s difficult to reconcile how this last, and therefore, one of the most important links in the supply chain, continually merits so little attention.” What’s certain is how detrimental failure to properly execute and validate shipping can be….

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