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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
A NEW Member Benefit for 2021
Welcome to the fall issue of RF Quarterly in which international experts from the US, EU, and Saudi Arabia examine quality and compliance and their governing regulations, with specific focus on data integrity, quality system design and management, current good manufacturing practice, and postmarketing activities in relation to medical devices, pharmaceuticals, and biologics.
1 Introduction: Quality and compliance Renée Matthews HTML 4 Data integrity and compliance with GxP: A pragmatic approach David W. Husman, PhD, ASQ CPGP, RAC HTML 19 Current good manufacturing practices and quality system design Joscelyn Bowersock, MS-RA, and Richard Vincins, CQP, MCQL, CBA, CQA, RAC HTML 41 Medical device quality management systems Gert Bos, MSc, PhD, FRAPS HTML 54 Medical device compliance and postmarketing activities Ryan Burke, RAC and Elizabeth Goldstein, RAC HTML 68 PMS and the role of CAPA in the medical device regulatory cycle: A Saudi perspective Mohammed Majrashi, PhD HTML 72 Biologics compliance Anne Marie Woodland, MS, RAC HTML
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