Designing a Comprehensive OOS Investigation Strategy

Venue: International Plaza Hotel & Conference Centre

Location: Toronto, Ontario,, Canada

Event Date/Time: Mar 07, 2005 End Date/Time: Mar 08, 2005
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- Regulatory expectations regarding failure investigation
- Recent History of OOS _ The Barr Case
- Key Elements of an Analytical Laboratory Investigation SOP
- Retesting Decisions
- Reporting Failure Investigations and Retest Results
- Investigation Process (Search for Cause/Root Cause)
- Documentation Requirements
- Tracking
- Trend Analysis
- Roles, Responsibilities and Guidelines for Documenting the Investigation and Subsequent Actions
- Summary Report Preparation
- Conduct, Review, and Approval of the Completed Investigation
- Implementation of Corrective and Preventative Actions (CAPA)
- Auditing the Failure Investigation

- Creating a Template for Developing an OOS SOP for the Pharmaceutical Laboratory
- Conducting OOS Investigation (Case Studies)
- Correct Usage of Averaging, Outliers (out of character results), and Exclusion of Data

Dear Friends and Colleagues:
The International Pharmaceutical Academy (IPA) is proud to bring you the “Designing a Comprehensive OOS Investigation Strategy” program. Investigation of out-of-specification (OOS), out-of-trend, and aberrant results are mandated by the court ruling of USA vs. Barr and FDA's draft guidance. These investigations have increasingly come under scrutiny by the FDA and numerous 483 observations continue to be issued in this area. During foreign and domestic FDA inspections conducted in the past years, the top ten 483 observation-categories included "failure (OOS) investigations" and common 483 observations included "no investigation of abnormal or missing analytical data" and "retest without appropriate investigation".

The essentials for conducting an investigation of an out-of-specification result in a compliant manner include having a well-organized and understood process; having well-informed and well-trained analysts, supervisors, and manufacturing personnel; and maintaining clear and concise documentation.

As an institute for providing quality training and skill development programs, IPA is proud to bring you this highly interactive course together with case studies and workshops to provide you with the comprehensive analysis of the effective handling and investigation of out-of-specification (OOS) results from three crucial points of view: Legal/Regulatory, Technical, and Statistical.

OOS investigations are time-consuming and expensive to perform, and can also increase regulatory exposure during inspections. This course will also cover measures necessary for; preventing and minimizing OOS and aberrant results, performing and documenting adequate and thorough analytical laboratory investigations, analyst and supervisor responsibilities, failure investigations, and retesting. Numerous case studies and in-class exercises are also incorporated to ensure a practical and useful learning experience.

Who Should Attend?
This is a ONE & HALF A-DAY course is valuable for Directors, Managers, Supervisors, Analysts, engineers and Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:
- Quality Control
- Quality Assurance
- R&D
- Analytical Laboratory
- Stability
- Documentation and Technical Writing
- Asses and Interpretation of test results
- Regulatory Affairs
- Product Submission
- Validation
- Product Development
- Change Control
- Project Management
- Training
- Contract Laboratories
- Consultants
- Contract Manufacturing
- Others who interact together to launch a product


655 Dixon Road

Additional Information

Certificate of Attendance: All participants will receive a certificate of attendance upon completion of the course Registration Fee Includes: Presentation Materials, Luncheon, Refreshments and Parking