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
Regulatory Affairs Departments
Quality Management Teams
Combination Products Design Personnel
Production Teamsuality Management Teams