Event Detail
Root Cause Analysis (RCA) & Corrective and Preventive Action (CAPA)
August 20 - 21, 2009
- Montreal PQ CANADA
International Pharmaceutical Academy
enquiry@ipacanada.com
Phone: 1-866-788-2518
Fax: 514-788-5034
A two-day Interactive Course & Workshops Featuring: Regulatory Perspective Identifying RCA by using a Flow-Chart Investigational Tools – FMEA (Failure Mode and Effects Analysis), Fault Tree Analysis Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions Essential SOPs and Other Documentation Root cause investigations Tracking and Trending Application and using effective RCA tools (Flow Charting, Fault Tree Analysis, Fishbone Diagrams, etc.) Identifying and tracking deviations and non-conformances Connecting Issue Review, Cause Analysis and Problem Prevention Outlining the requirements of the CAPA process and procedure including building a CAPA file. Definition of the essential elements of the CAPA file and their intended purpose Preparing CAPA SOPs & Reports Establishing a CAPA plan: project definition, individual responsibilities and expected completion dates. Documentation for root cause analysis in the CAPA file. QSR and ISO 13485 requirements for CAPA Elements of a successful CAPA system Practical Problem Solving Process CAPA Process Summary