Source: http://www.labcompliance.com/seminars/audio104/default.aspx
Timestamp: 2017-04-24 01:38:36
Document Index: 505847106

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

On-line Audio Seminar 104
Requirements, New Scope and Recommendations for Implementation
In 1997 the United States Food and Drug Administration (FDA) issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. This was done in response to requests from the industry. With this regulation, entitled Rule 21 CFR Part 11, electronic records can be equivalent to paper records and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP).
Where to get reference material (gap analysis, examples, worksheets, SOPs) for easy implementation? How does the on-line audio seminar help:
How to document risk assessment for the FDA?
SOP: Define and document scope and controls for part 11
Gap analysis for part 11
SOPs: GxP and part11 training, Remediation plan and schedule
Paper: 21 CFR Part 11 - Introduction
Paper: New scope of part 11
FDA 483 form inspectional observations and several warning letters with deviations related to Part 11
All old and new FDA guidance documents for Part 11
QA managers and personnel All developers and users of spreadsheet applications
Understanding FDA's 21 CFR Part 11 Introduction and Strategies and Tools for Implementation