Indian Rocks Beach, FL 33785
(727) 642-0182
(813) 774-8657
(727) 593-3595 FAX
"Helping People Learn Compliance and Science" SM
How To Conduct An Out Of Specification
(OOS) Investigation
ABOUT THE COURSE
“How To Conduct An Out Of Specification (OOS) Investigation” is a one day course designed to review the critical skills and knowledge required for conducting laboratory out of specification (OOS) investigations and laboratory investigations in general. This course focuses on how to conduct scientific investigations and meet regulatory requirements. Scientific investigations lead to more robust test methods and reliable laboratory operations. Also included are: how to document investigations and convince reviewers; and how to demonstrate an effective OOS management program.Current FDA guidelines for conducting, reporting and evaluating laboratory investigations will be reviewed. Laboratory personnel will learn strategy and effective techniques for conducting scientific investigations in their laboratories. Extensive examples of laboratory investigations with effective corrective and preventive actions will be used throughout the course. Participants will conduct laboratory investigations of pharmaceutical OOS events in a workshop setting. They will take home tools and experiences for use “back at their lab”. Knowledgeable and experienced faculty will be available to discuss OOS solutions in-depth.
WHO SHOULD ATTEND
Chemists responsible for collecting and recording GMP data, and those supervisory personnel, management and quality unit personnel responsible for performing, evaluating, reviewing or approving laboratory investigations of OOS results will benefit from this course.COURSE OUTLINE
1. Introduction to Laboratory Out of Specification (OOS) Investigations
2. Reasons for Conducting Laboratory Investigations
3. Procedures for Conducting Laboratory Investigations
4. Documenting Laboratory Investigations
5. Tracking and Trending
6. Process Improvement
7. Case Studies
8. Practical Exercise
9. Summary
10. Questions and Answers
ADMINISTRATION
The course is one day in length. Cost is $525 per person, with a ten-student minimum for on-site presentation. Payment can be made by personal check, company check, purchase order, or by MasterCard, Visa, or American Express. Registration can be made on-line or via telephone.
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