Details 
#625 Document Control and Records Management in Regulated Environments
Course Content: This overview course focuses on the regulatory environment in the US for management of standard operating documents and the subsequent management of the resulting paper and electronic records. It is updated annually and designed to provide practical knowledge for managing a document control or records department in a manufacturing company. The course provides a basic understanding of the national and international laws and their impact on the lifecycle of documents from use in the FDA manufacturing environment to records retention and disposition. Course covers: 21 CFR 11, Electronic Records and Electronic Signatures, 21 CFR 210 & 211 cGMP Manufacturing 21 CFR 820 Quality System Regulation (Devices) ICH Guidelines Q7A cGMP for Active Pharmaceutical Ingredients ISO 9000, ISO 13485 Quality Management System (Medical Devices) ISO 17799 Information Security. Overview of archival practices and how that differs from records retention. Overview of current security and privacy laws and the effect on the controls inherent to document control and records retention. Discussion of how the FDA and EMEA see document control and records management from an auditing standpoint and some audit tips. CD with regulatory texts.
Course Length: 8 hours
Instructor: Deborah Blackmon, CQM/OE, CQIA, Manager of the Corporate Facilities Services Document Control Group at Genentech Corp. in South San Francisco CA.
Email: deborahblackmon@earthlink.net
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