Effective Control of Documents and Records in Accordance with 21 CFR, Part 820 Subpart D & Subpart M

The effective control of documents and records becomes the cornerstone for all quality management systems. Failure to adequately control documents and records in accordance with quality, regulatory, and statutory requirements will result in the FDA issuing Form 483 observations during an agency inspection.

If your organization is struggling with understanding the salient requirements associated with the control of documents and records, this webinar is for you. This webinar will help your organization better understand the FDA’s expectations for the control of documents and records, while providing insight into tools needed for establishing an effective approach for document control and records control.

For establishments already having a compliant approach to document and records control, this webinar will help reinforce requirements necessary to remain in compliance with FDA requirements.

Areas Covered in the Session :
Reviewing and understanding the requirements associated with 21 CFR, Part 820, Subparts D & M
Similarities with ISO 13485 requirements
Understanding current industry practices
Establishing effective document and record oversight
Components for an effective document control system (review, approval, and changes
Establishing an effective approach to the control records
Defining record retention periods
Identifying Quality records (DHR, DMR, & QSR)

Who Will Benefit:
Research & Development Departments
QA/QC Departments
Regulatory Affairs Departments
Quality Management Teams
Documentation Departments
Combination Products Design Personnel
Production Teamsuality Management Teams

Dr. Christopher J. Devine

Dr. Christopher Joseph Devine is the president and founder of Devine Guidance International, Inc., (DGII) a consulting firm providing regulatory and quality compliance support for the medical device industry. Prior to launching DGII, Dr. D spent 14-years with Boston Scientific Corporation working in a variety of quality and regulatory management roles. Additionally, Dr. Devine is the author of Devine Guidance, a weekly blog focusing on quality and regulatory compliance issues facing the medical device industry; and published by the Medical Device Summit, an e-magazine.

Furthermore, Dr. Devine has 35-years of combined experience in the fields of quality assurance and regulatory affairs; and is a senior member of the American Society of Quality (ASQ), a member of Regulatory Affairs Professionals Society (RAPS), a member of the Society of Manufacturing Engineers (SME), and a member of the Project Management Institute (PMI).

Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation entitled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study. Finally, Dr. Devine is the author of five books on quality and regulatory compliance.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance