Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely.
The objective of this live training webinar is to develop an understanding of how a compliant laboratory handles the investigation of OOS test observations and how the laboratory interfaces with other units through the laboratory investigation process. The interactive live discussion will be based on the FDA guidance on handling OOS laboratory results and to provide a clear process for compliant laboratory OOS investigations.
Webinar Takeaway
- The requirements for laboratory OOS investigations.
- Latest Regulatory expectations.
- The laboratory OOS investigation process.
- Laboratory investigation, Phase I.
- Laboratory investigation, Phase II.
- Retesting.
- Resampling.
- Communicating with Quality Assurance.
Learning Benefits:
- Understand the developing expectation for appropriate OOS investigations.
- Understand of the expectation for the identification of the cause of the OOS results.
- Gain a clear insight of the laboratory OOS investigation process.
- Learn the terminology associated with laboratory OOS investigations.
- Learn about outlier testing.
- Understand how the OOS laboratory investigation process relates to the general expectation for deviation investigation.
Regulations and Guidance that will be covered (FDA, EU, Canada, WHO, ICH, other):
- US - 21CFR211.160, 192
- ICH Q7; 11.1
- FDA Guidance for the Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
Speakers
Ms Kelly Thomas,
Vice President ,
Stallergenes GreerMs. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
Who Should Attend
The following individuals or disciplines will benefit from attending this Webinar:
- Senior management
- Production management
- Quality management
- Quality Assurance
- Quality Assurance Product Reviewers
- Regulatory
