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FDA Auditing of Computerized Systems and Part 11/Annex 11

Healthcare Conferences | Topics: Annex 11, Compliance, Computerized Systems, Data Integrity, Data Security, Electronic Records, Electronic Signatures, FDA Audits, Inspections, Part 11, Validation

3-Day, Hands-On Part 11 Compliance and Inspection Readiness Training from the Same Instructors Who Trained the FDA and Health Canada. You?ll learn: ? Part 11 rules for electronic records and signatures ? How Part 11 compares with the EU?s new Annex 11 ? Key principles of computerized system validation ? How FDA expects you to validate configurable, off-the-shelf software ? …