Engaged. Knowledge. Application
Part 11 FDA Inspections CONTENT Package
Package includes one webinar recording, one powerpoint presentation and a compliance assessment checklist:
➢ 1. FDA Part 11 Inspections: A Primer for Successful Execution (One Hour Webinar Recording)
➢ 2. FDA Part 11 Inspections: A Primer for Successful Execution (PowerPoint Training Presentation)
➢ 3. Part 11 System Compliance Assessment CHECKLIST
1.& 2. FDA Part 11 Inspections: A Primer for Successful Execution (One Hour Webinar Recording & PowerPoint Training Presentation)
➢ About 21 CFR Part 11
➢Preparing for an FDA inspection
➢Hosting an inspection
➢Commonly asked questions
➢Appropriate responses
➢Warning letters
➢Target areas
➢Trends
➢Benefits of being compliant
➢Information resources
3. Part 11 System Compliance Assessment CHECKLIST
This nine (9) page checklist includes sections on the following subject matter below:
➢Validation & system documentation
➢Training & SOP
➢Record and integrity protection
➢Record output
➢Sequence and device control
➢Application security & user authority
➢ID code/password controls
➢Records-audit trail, retention, retrieval & deletion
➢Open controls
➢E-signature data & components
➢E-signature controlled session
➢PART 11 FDA Inspections CONTENT is only $129.00. Purchase now in the enKap store - click here
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