This Out-of-Specification Investigations webinar will begin with the confirmed out-of-specification laboratory result and discuss how the investigation is expanded into the whole organization.
Why Should You Attend :
Although the Barr Decision of the early 1990s surfaced the concern about out-of-specification results and investigations, many organizations have not determined how to effectively address the issue. Out-of-specification results bring out many reactions in the pharmaceutical firm: .emotional, political, finger pointing, denial. This inhibit a productive investigation and a timely conclusion of the investigation.There is still confusion in the pharmaceutical firm as to how to handle that is demonstrated to be out-of-specification.
The webinar participants will learn the origin of the term out of specification and FDA concerns and opinions. They will be led through a process for the successful completion of OOS investigations.
The webinar will begin with the confirmed out-of-specification laboratory result and discuss how the investigation is expanded into the whole organization.
The involvement of QA, Production, Packaging, Materials Management and Quality Control will be discussed.
Areas Covered in the Seminar:
- Introduction.
- Terminology.
- The confirmed out-of-specification result.
- The investigation team.
- Review of batch records.
- Review of materials.
- Investigation report.
- Corrective action.
- Preventive action.
Who Will Benefit:
The following individuals or disciplines will benefit from attending this Webinar:
- Personnel responsible for investigations, CAPA and Change Control
- Quality Control analysts
- Quality Control record reviewers
- Quality Control Supervisors
- Quality Control Managers
- Quality Assurance record reviewers
- Quality Assurance Supervisors
- Quality Assurance Managers
- Production Supervisors
- Personnel working with contract laboratories
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.
