Implementation of Effective & Compliant CAPA Programs Workshops, Case Studies & Interactive Exercise

Venue: Boston

Location: Boston, Mass, United States

Event Date/Time: Jun 15, 2010 End Date/Time: Jun 16, 2010
Registration Date: Jun 15, 2010
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Description

A Two-day interactive Workshop and Case Study Sessions on:
Regulatory Requirements for CAPAs
Understanding of CAPA System
Elements of a Corrective Action Program
Common misconceptions about CAPAs
The importance of a Process Improvement Team in a strong CAPA program
Global Harmonization Task Force - SG3
Harmonization in Medical Device Regulation - New Draft Guidance on CAPA
How FDA Trains its Inspectors to Review CAPA, and Recommended Compliance Methods (Workshop)
Beyond Procedures and Checklists – Organizational Practices that impact CAPA Effectiveness
Integrating Risk Management and CAPA: A Core and Fundamental Management Responsibility
Addressing Deviations and Process Failures within a CAPA program
Auditing the Failure or Process Deviation Investigation (Workshop)
Handling OOS Results and Laboratory Failures
SOPs & Reports for Failure Investigations and Deviations
CAPA Trends & Practices- From Initiation to Closure
Verification and Validation in a CAPA project – When to do what?

Venue

Boston
Boston
Mass
United States
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