The Drug Quality and Security Act, signed into law in November 2013 by President Barack Obama, is designed to ensure the safety of the pharmaceutical supply chain. Title II of DQSA, the Drug Supply ...
Anyone who has been closely following the Department of Defense’s (DoD) Cybersecurity Maturity Model Certification (CMMC) program knows the effort has experienced a fair number of complications and ...
Dean Smith held the first facilitated two-day leadership retreat. The goal of this retreat was to identify areas of emphasis needed to operationalize the current strategic plan. Working from the ...
Effective pre-implementation planning is critical for successful adoption of intelligent process automation (IPA). The comprehensive IPA pre-implementation framework outlined in this document provides ...
The FDA’s proposal to harmonize the Quality System Regulation (QSR) with ISO 13485 has finally become more than just a hot topic among device makers, and the agency held a March 2 advisory hearing on ...
Capital markets regulator Sebi, on 7 January 2026, extended the timeline till 1 March 2026 for the implementation of an ...
The U.S. FDA’s proposal to restructure the Quality System Regulation (QSR) with ISO 13485, the international quality system standard, is a major shift for affected industry, but there are strictly ...
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