New Course

This CAPA procedure includes a webinar, but the focus is on implementing the procedure and customizing it for your company. In contrast, the risk-based CAPA training webinar explains the details of performing a CAPA investigation, identifying the root cause, writing a corrective action plan, and performing effectiveness checks. The risk-based CAPA training is recommended for anyone without prior CAPA experience.

About the course

Includes: - SYS-024, CAPA Procedure - LST-005, CAPA Log - FRM-009, CAPA Report - Native Webinar Slide Deck - Webinar Recording - Revised requirements for ISO 9001:2015 and ISO 13485:2016 - An outline of the CAPA process and proposed risk management activities - Various risk control options that can be integrated with corrective actions - How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016 - Root Cause Analysis Tools - 5 Why Analysis - Is/Is Not Analysis - Fishbone diagrams - Brainstorming - Pareto analysis - Effectiveness checks - Sources of corrective and preventive actions - Pareto analysis of service issues - Trending CAPAs, average aging of CAPAs, “Death by CAPA” - Risk Management: risk-based CAPAs, risk thresholds, 7 criteria for estimating risk - Documenting CAPAs - How to write an effective CAPA SOP - Auditing the CAPA process - Problem-solving A3 reports - Key elements of CAPA forms

Curriculum

2 Chapters · 8 Lessons

1
1. (Included in full purchase)
  SYS-024: Capa Procedure Webinar
2. (Included in full purchase)
  SYS-024: CAPA Procedure (Slides)
3. (Included in full purchase)
  SYS-024: CAPA Procedure
4. (Included in full purchase)
  FRM-009: CAPA Report
5. (Included in full purchase)
  LST-005: CAPA Log
2
1. (Included in full purchase)
  Risk-Based CAPA Process Webinar
2. (Included in full purchase)
  Risk-Based CAPA (Slides)
3. (Included in full purchase)
  Risk-Based CAPA Exam

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