"I can recommend Pauline’s workshop on the lifecycle approach for analytical procedures if you want to learn more about this important topic. If you want to find out more about the future direction of ICHQ2 and the new ICHQ14 guideline on Analytical Development then this is a must!."
Phil Borman Director, Quality by Design Development Lead for Small Molecules at GSK
Investigating OOS Results in a GMP Environment
This course is designed to provide essential training for conducting Out of Specification (OOS) investigations in a GMP laboratory.
The focus will be on those results generated during laboratory testing including a step-by-step approach on how to conduct and document an OOS result investigation in compliance with an regulatory audit.
The documentation required to support the OOS investigation is presented 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
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 published in 2017.
Participants are welcome to bring their own examples for group discussion sessions.
This course is not applicable to Microbiology methods.
The workshop emphasizes practical issues such as:
• What is an OOT?
• GMP documentation (quality systems) required to support OOS investigation
• FDA audit observations and how they could have been avoided
• Investigation approach and tips for success
• Case studies for OOS results
• A detailed guide to conducting Phase 1 of the OOS investigation
• Reporting and evaluating passing and failing results
• Corrective and Preventative actions
• Minimising future OOS
Who Should Attend?
This One-day course is valuable for 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
- Contract Laboratory
- Analytical Laboratory
What’s included with the course?
Each participant will receive:
- A certificate of attendance upon completion of the training course.
- Printed materials and handouts relating to the training course
- Lunch and light refreshments each day.
Pauline McGregor, PhD. CChem MRSC has over 30 years experience in the pharmaceutical industry.
She is an expert in quality systems and procedures, GMP regulations and analytical chemistry. She brings a technical expertise to laboratories which enable her to assist them to develop, transfer, verify and validate analytical procedures, and also optimize efficiency with regards to laboratory operations and troubleshooting in an analytical development and QC environments.
She has utilized her skill set globally in the UK, Canada, US, Jordan, Brazil and China and has helped companies prepare for a GMP inspection to gain their European/Health Canada/FDA GMP licenses.
Pauline was a member of the USP expert panel for Validation, Verification and Transfer of Analytical Procedures and is currently on a USP Chemical Medicines expert committee. Pauline is also a member of The Royal Society of Chemistry, UK.
|Course Date||Mar-25, 2020 8:45 am|
|Course End Date||Mar-25, 2020 5:00 pm|
|Registration Start Date||Jan 29, 2020|
|Cut off date||Mar 13, 2020|
|Course Leader||Dr. Pauline McGregor, Ph.D. Chem, MRSC|