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 "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.

Course Leader

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 Properties

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
Individual Price £620.00
Course Leader Dr. Pauline McGregor, Ph.D. Chem, MRSC
Location BioCity Nottingham
£620.00 15

Contact PMcG Consulting directly for your in-house GMP training needs. Explore our website for all in-house training topics

Pauline McGregor is a member of the Royal Society of Chemistry and is listed on the RSC Directory of Consultants

Recommendations

  • Pauline is keen and hardworking, she loves her sciences and passionate about what she does. I so much enjoyed working with her, she has provided great insight on many technical and scientific issues related to analytical method development and analytical method validation. Her most important quality is her patience and perseverance and of course, fun to work with
  • Contracted Pauline to assess analytical methods validation, and to subsequently create a 'gap' report - and then to work at 'fixing' the gap. Pauline was excellent in her attention to detail, and her thorough knowledge of what was needed. She also worked on several projects after that one - always with the same high standards and commitment to provide value to the client. I heartily endorse her work.
  • Pauline is an excellent professional in the life science business. She did a great job as project manager in analytical development and validation at SGS Life Science Services. She was appreciated by her colleagues and her customers.
  • Pauline's ability to understand and integrate the scientific challenges of industry, with government and academia are unsurpassed. I am so confident with her ability to deliver meaningful yet pragmatic leadership as it applies to the pharmaceutical industry that I have recommended her to numerous prominent companies who have subsequently hired her and been extremely happy with the results she is able to deliver.