Inspections Hashtags
Quality Risk Management for FDA/ICHQ9 Compliance
Healthcare Conferences | Topics: Audits, Compliance, Fault Tree, FDA, FMEA, HACCP, HAZOP, ICHQ9, Inspections, ISO Standards, Process Maps, Quality Systems, risk management- FDA?s expectations for managing people, product and process risks – The language of risk ? key concepts and definitions of risk management used by FDA and international bodies – The regulatory requirements for risk management – Proven tools for risk assessment, management and hazard control (with hands-on practice) – How to better integrate risk management with your quality system …
The CAPA Confidence Clinic: Effective CAPA Systems
Healthcare Conferences | Topics: CAPA, Compliance, Compliant Management, Corrective & Preventive Action, Failure Investigation, FDA, Feedback Loop, Inspections, QSR, Quality Systems, Root Cause Analysis- Identify the best CAPA data sources and gather useful feedback from throughout your organization – Select and apply appropriate CAPA tools to resolve real-world quality issues – Conduct a proper failure investigation and accurately identify root causes Details: Info@EduQuest.net
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, Validation3-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 ? …
Inspections Influencers
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