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

Start Date:
Wednesday, 18 May, 2016
End Date:
Wednesday, 18 May, 2016 2:00pm
Dermatology, Internal Medicine, Physical Medicine, Business Practice, Health & Nutrition

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 & MSimilarities with ISO 13485 requirementsUnderstanding current industry practicesEstablishing effective document and record oversightComponents for an effective document control system (review, approval, and changesEstablishing an effective approach to the control recordsDefining record retention periodsIdentifying Quality records (DHR, DMR, & QSR)Who Will Benefit:Research & Development DepartmentsQA/QC DepartmentsRegulatory Affairs DepartmentsQuality Management TeamsDocumentation DepartmentsCombination Products Design Personnel Production Teams


5939 Candlebrook Ct,
ON L5V 2V5,

Organizer Details

Conference organized by Compliance Trainings

This new 2-day Seminar on Computer Systems Validation will explore proven techniques for reducing costs associated with implementing, using, & maintaining computer systems in regulated environments. The FDA performs GxP & Part 11 inspections, with an updated Annex 11 regulation, & companies must update their systems and processes to maintain compliance.

861, Peripheral Road, Koramangala, Bangalore

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