This Out-of-Specification Investigations (OOS) training/webinar will guide you through initial laboratory investigation which follows the FDA guidance; Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
Why should you attend :
It is important that the Quality Control Laboratory and the entire organization understand the impact of an Out-of-Specification result and what is required for an investigation that will survive the scrutiny of the regulatory investigators. This seminar will help the organization complete timely, compliant investigations that identify the root cause and appropriate corrective and preventive actions.
This seminar discusses what should be done when an analyst obtains a test result that is not within defined limits or one that is out of the historical trend for the test. The discussion begins with the initial laboratory investigation which follows the FDA guidance; Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. The seminar then considers what must be done if there is not an attributable laboratory error to include retesting and the involvement of the entire organization in the event that the original result is confirmed.
Areas Covered in the seminar:
- Brief history on the emphasis of Out-of-specification results. - Why is the FDA interested, the Barr trial.
- OOS investigations, an overview.
- Laboratory Investigations - OOS Guidance - Phase I, Phase II.
- Retesting - guidance, protocol, establishing that the original is an outlier.
- Investigations beyond the laboratory - The deviation system, working with QA, production, facilities and materials management.
- The investigation process.
- Integrating with other quality system components - Investigations, CAPA, Change, Validation.
Who will benefit:
- Laboratory supervisors
- Analysts
- QA personnel responsible for reviewing laboratory records
- QA personnel responsible for investigations
- QA management
Instructor Profile:
John G. (Jerry) Lanese, PH.D. CMC is the President of The Lanese Group, Inc, an independent consulting service provider that specializes in Quality Systems and Laboratory Controls. Jerry has taught at the college level and worked in various Quality Control and Quality Assurance roles in small and large pharmaceutical firms. For the last 15 years he has consulted in a wide range of projects from consent decree remedial actions with large pharmaceutical firms to systems development for a small component manufacturer. He has lectured throughout the world to clients and for major seminar providers. He was voted the best presenter of the year in 2001 by the Institute of Validation Technology. In 2008 he received the Kenneth Chapman Industry Recognition Award.
