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Date: 18th - 19th June, 2008

Location: Toronto, Canada

Summary:
Pharmaceutical - Training, Seminar

A TWO DAY COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES, & WORKSHOPS ON:

- Regulatory Expectations for RCA and CAPA
- Common Categories of Root Causes and Contributing Causes
- Responding to Non-Compliance, Failures, Deviations, Complaints
- Effective Steps for Conducting Root Cause Analysis
- How to Review your Quality Data
- Selecting and Using Problem Solving, Investigation and Measuring Tools
- Performing Trend Analysis and Fault Tree Analysis
- Utilizing the 5 Why's, Fishbone, Flow Charting
- Identifying the Extent of Product or Quality Problems
- Utilizing CAPA and Monitoring your Quality System
- Measuring, Monitoring, and Confirmation Activities
- Designing and Implementing a CAPA Program
- Oganizational Aspects of CAPA
- Analyzing Objectives to Identify Potential Problems
- Developing Essential SOP's and Training Plans
- Preparing Documentation for Inspections
- Consequences of CAPA Failures
- Validation of Corrective and Preventive Actions Program

Case Study Disucssions and Interactive Activities
- Strategies for Information and Data Gathering
- Implementing and Conducting a CAPA Review Board Meeting
- Reviewing 483 Observations and Determining Proper CAPA documentation