Description :

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 Teams

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1911