Investigating Out-of-Specification (OOS) Course Description
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 Guidances 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
Who will Benefit?
This webinar will provide a great resource to Pharmaceutical, Biotechnology, Biologics, Drugs, Medical Device, In-vitro Diagnostics Industry personnel within the following functions:
- - Quality Control
- - Quality Assurance
- - Microbiologist
- - Chemist
- - Analysts
- - Manufacturing
- - Validation
- - Facilities
- - Materials
- - Engineering
- - Management
Know Your Faculty
Kelly Thomas, Head Of Quality Assurance (USA)
Highly experienced Quality Assurance / Quality Control / Regulatory Compliance leader with experience in API, biologics / biotech, both aseptic and terminally sterilized manufacturing processes, medical devices, drug / device combination products, and all pharmaceutical dosages (Sterile Injectable, OSD, Controlled Substances, Aerosols).
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.
High degree of quality understanding and ability to apply knowledge of global regulatory requirements particularly with process / equipment validation, new product and technology transfer, lot/process investigations, quality systems, quality control, data trending, lab equipment and validation.
