Engaged. Knowledge. Application
Part 11 CONTENT Power Package
Package includes three webinar recordings, three PDF powerpoint presentations, one FAQ Document and a compliance assessment checklist:
➢ 1. and 2. FDA Part 11 Inspections: A Primer for Successful Execution (One Hour Webinar Recording and PDF PowerPoint Training Presentation)
To view complimentary excerpt - click here
➢ 3. and 4. Conducting Effective Internal/External Part 11 Audits: An Auditor Tells How (One Hour Webinar Recording and PDF PowerPoint Training Presentation)
➢ 5. and 6. 21 CFR Part 11: A Primer for Implementing Audit Trail (One Hour Webinar Recording and PDF PowerPoint Training Presentation)
To view complimentary excerpt - click here
➢ 7. Part 11 System Compliance Assessment (CHECKLIST)
➢ 8. Frequently Asked Questions and Answers (DOCUMENT)
1. and 2. FDA Part 11 Inspections: A Primer for Successful Execution (One Hour Webinar Recording & PDF PowerPoint Training Presentation)
To view complimentary excerpt - click here
➢ 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. and 4. Conducting Effective Internal/External Part 11 Audits: An Auditor Tells How (One Hour Webinar Recording & PowerPoint Training Presentation)
➢ About 21 CFR Part 11
➢ Planning the audit
➢ Preparing for the audit
➢ Executing the audit
➢ CAPA, responses and follow up
➢ Common audit findings
➢ Common pitfalls
➢ Tools
➢ Tools-audit trail
➢ Information resources
5. and 6. 21 CFR Part 11: A Primer for Implementing Audit Trail (One Hour Webinar Recording and PDF PowerPoint Training Presentation)
To view complimentary excerpt - click here
➢ 21 CFR 11.10.e
➢ 21 CFR 11.10.k.2
➢ Types of audit trails
➢ Strategies for implementing audit trails
➢ Audit trail-pros and cons
➢ Audit trail-auditing tool
➢ Audit trail-shoulds and shouldn’ts
➢ What if’s
➢ Commonly asked questions
➢ Warning letter
➢ FDA Intentions
7. 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
8. Frequently Asked Questions and Answers DOCUMENT
This two (2) page document includes 10 frequently asked questions and answers related to conducting effective Part 11 audits.
Part 11 CONTENT Power Package is now only $159.00...
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