Event Detail
Integrating Risk Management into the CAPA Process
August 25, 2009
- Online Not Applicable
BenAstrum Pharma Broad
ardy.heydari@benastrum.com
Phone: (514) 337-1616
Fax: (514) 337-8803
Course Highlights: -ISO 14971 requirements for the Production and Post-production phases of the product lifecycle -How does Risk Management fulfill regulatory requirements? -How does Design Output requirement for “Essential Outputs” relate to Risk Management and to Production and Post-production processes? -How do you use the Risk Analysis in review of complaints and CAPA activities? -How does Risk Analysis relate to Health Hazard Evaluation when recalls are contemplated?