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2021 RF Quarterly Q1

RF Quarterly,  October 2021: Quality and compliance

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.

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Table of Contents

1    Introduction: Quality and compliance
          Renée Matthews
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4   Data integrity and compliance with GxP: A pragmatic approach
         David W. Husman, PhD, ASQ CPGP, RAC
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19  Current good manufacturing practices and quality system design
           Joscelyn Bowersock, MS-RA, and
           Richard Vincins, CQP, MCQL, CBA, CQA, RAC

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41  Medical device quality management systems
           Gert Bos, MSc, PhD, FRAPS
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54  Medical device compliance and postmarketing activities
           Ryan Burke, RAC and Elizabeth Goldstein, RAC
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68  PMS and the role of CAPA in the medical device regulatory cycle: 
         A Saudi perspective
           Mohammed Majrashi, PhD
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72  Biologics compliance
           Anne Marie Woodland, MS, RAC
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Upcoming in RF Quarterly
  • RAPS 2021 Convergence (December 2021)
  • Software as a medical device (March 2022)
  • Regulatory history (June 2022)
  • Strategy in regulatory affairs (September 2022)
  • RAPS 2021 Convergence (December 2022)
To contribute to the upcoming issues, email rmatthews@raps.org.
 
For more information, see Guidelines for Authors and the 2021 Editorial Calendar and 2022 Editorial Calendar.
  
Join now to view the current issue of RF Quarterly 
 
Previous issues
Access more benefits in the former Article Series  on the following topics:
  • Regulatory Intelligence
  • The Shifting Global Regulatory Landscape
  • Global Regulatory Strategies and Best Practices
  • The Strategic Role of the Regulatory Professional
  • Risk Management and Quality
  • Global Strategies for Drugs and Devices
  • Executive Leadership and Management
  • Global Regulatory Policy and Strategy
 

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