Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "Master Validation Plan - The Unwritten Requirements" training has been added to ResearchAndMarkets.com's offering. FDA Warning Letters and recent ...

DUBLIN--(BUSINESS WIRE)--The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop "conference has been added to ResearchAndMarkets.com's ...

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating ...

Life science companies are increasingly investing in holistic talent management systems (TMS), where learning management presents an important feature. However, the question that arises at this ...

As discussed in my previous post (How to Define Meas urable and Traceable Requirements for SharePoint Projects), focusing on the business requirements first, user requirements second and then ...

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Vivek Yadav, an engineering manager from ...

The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider ...