Effective Response to Process Deviations and Failures Investigations

Venue: Toronto

Location: Toronto, Ontario, Canada

Event Date/Time: Oct 09, 2008 End Date/Time: Oct 10, 2008
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Description

A One & Half Day Comprehensive & Interactive Workshop, with Interactive Discussions, Case Studies, and Workshop On:

- Rules, Regulatory Expectations and International Requirements for Process Failures and Deviations
- Defining the Level of Risk and Impact Assessment of Failure
- Strategies for Problem Identification and Problem Solving Approaches
- Identifying Sources of Non-Conformance and quality improvement data
- Tracking and Eliminating Non-Conformances and Deviations
- Manufacturing Process Deviations that warrant investigation
- Essential Steps of a Thorough Failure Investigation
- Reporting Major and Minor Non-Conformances
- Problem Solving Approaches and Failure Analysis
- Conducting an Effective Root Cause Analysis (RCA)
- Statistical Tools and Trending Non-Conformance Data
- Thorough Reporting of Failure Investigations and Process Deviations
- Obtaining Approval of an Investigation Report
- Documenting a Close-Out and Validating CAPA
- Auditing the Failure or Process Deviation Investigation
- Handling OOS results and Laboratory Failures
- Developing SOPs for Reporting and Addressing Process Deviations

Venue

Toronto
Toronto
Ontario
Canada
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