OOS Investigations for Testing Laboratories in a GMP Environment
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Distinguished Faculty
Steven Tanner
Mr. Steven Tanner has worked for and partnered (GQRP) with the top global pharmaceutical manufacturing, contract research, wholesale and specialty distribution organizations in both Europe and North America. From Eli Lilly UK to Merck KGaA (now Mylan) in Canada, Pharmanet (now Inventiv Health), Teva, and the McKesson Corporation, Steven now surpasses more than 18-years of progressive GxP industry experience in quality, compliance and technical training senior leadership roles.
Steven’s specialties include leading FDA and Health Canada GMP inspections, customer 3rd party logistics (3PL) quality & qualification audits, as well as the hands-on design, strategy, execution and management of GxP regulatory quality systems: change controls, deviation controls, CAPA, validation/21 CFR Part 11, document controls, environmental monitoring, complaints, equipment & shipment qualifications, SOPs, technical writing, drug recalls, quality agreements, self-inspections. Steven has also partnered since 2004 with AAPS – Academy of Applied Pharmaceutical Sciences where he’s provided quality assurance/GxP technical facilitation. In 2016 Steven accepted a full-time role as Campus Manager and Director of Student Affairs with AAPS.
Steven graduated in 1999 with an honours degree in Chemistry from Leicester University in the United Kingdom and holds a postgraduate diploma in Adult Education from St Francis Xavier University, Nova Scotia, Canada.–>
Abstract:
This course is designed to provide essential training for conducting Out of Specification (OOS) investigations detected in the laboratory (Phase 1). A background discussion of the associated GMP documentation required to support the OOS investigation is included but the majority of time is spent detailing the who, what, when, how and why of the investigation, documenting findings and determining root causes to identify if the OOS is valid or can be assigned to analyst or laboratory error. Corrective and preventative actions are also discussed. An introduction to OOT (Out of Trend) results with respect to analytical and compliance alerts related to the laboratory is included, using industry examples in the first session of this course.
This course is presented in a dynamic environment created by a power point presentation, interactive exercises, case studies and group discussion. Participants are welcome to bring their own examples for group discussion sessions.
The workshop emphasizes practical issues such as:
- What is an OOT?
- The importance of good quality support systems
- FDA audit observations and how they could have been avoided
- Case studies for OOS results
- A detailed guide to conducting Phase 1 of the OOS investigation
- Reporting and evaluating passing and failing results
The course provides ample opportunities for group discussions, case studies and exercises. It enables participants to gain the skills and knowledge necessary to meet current regulatory expectations. The course material is based on the FDA guideline ‘Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production’, October 2006, FDA audit observations and the MHRA guidelines 2012.
Course Outline
- Introduction and definition of OOS
- Review of FDA’s guidelines (2006)
- Examples of regulatory observations
- Quality documentation required to support OOS investigations
- Responsibilities
- Additional Laboratory Testing (Hypothesis, Remeasurement, Retesting and Resampling)
- Investigating OOS Results – Phase 1
- Determining the root cause (exercise)
- Common Laboratory errors
- Regulations and industry response to invalidating OOS Results
- Reporting test results
- Concluding the Investigation and Evaluating the Results
- Corrective and Preventative Actions
- Minimising future OOS results
Note: Course outline is subject to change without notice. Please check back regularly for updates.
Who Should Attend
This course is valuable for Directors, Managers, Supervisors, Laboratory Analysts and Associates working in a GMP environment in the Pharmaceutical and related industries with daily responsibilities in the following areas:
- Quality Assurance
- Documentation and Technical Writing
- Quality Control Laboratory
- Regulatory Affairs
- Contract Laboratory
- Analytical Laboratory
- Training
Certificate of Attendance and Course Material
- All participants will receive a certificate of attendance upon completion of the course.
- The participants will be receiving specially prepared course manual.
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Registration Fee Includes
Presentation Materials, Luncheon, Refreshment and Free Parking
Note: Please indicate any special Dietary requirements when registering for the course–>
