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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

Enhanced Approach and Lifecycle Management for Analytical Procedures

thumb statapultCourse Objectives and Learnings

Benefits/advantages to attending this course are:
o Improve performance of analytical procedures
o Improve understanding of analytical procedures
o Reduce the number of OOS results due to poor method performance
o Increase success of transfer or verification analytical procedures
o Reduce non-value-added activities during investigations, development, verification and transfer
o Improve knowledge transfer and communication
o Keep up to date with best practices and guidelines for analytical procedures

This 2-day technical training course integrates the following principles of QbD and the lifecycle management to analytical procedures into current practices (Development, verification and transfer) to improve and maintain the performance of analytical procedures.

  • Knowledge gathering
  • The acceptance criteria target profile
  • The Analytical Control strategy (identifying and controlling the appropriate method parameters)
  • Risk Assessment Tools 
  • The qualification process
  • Monitoring analytical procedures for acceptable performance throughout its lifecycle.

A fun, hands on practical component using a Statapult has been designed to demonstrate setting a target profile, investigating and controlling variables for the procedure and qualifying the procedure against the predetermined target.

Case studies are included for development of a new procedure, a method transfer and a verification of a compendial monograph procedure.

This workshop is based on ICH Q8, Q9, Q10 and Q11 which have been adapted to suit analytical procedures. It also provides an update on the proposed new chapter ICHQ14 (Analytical Procedure Development), proposed updates to ICHQ2 (Analytical Validation).

Although the material is based on HPLC for small molecules, the principles taught and the practical session, may also be applied to analytical procedures for large molecules.

For more information please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

Who should attend?
Chemists or management involved in the testing of pharmaceutical products
Managers, Supervisors, Laboratory Analysts and Associates involved in the development, validation, transfer, testing or review of analytical procedures in the Pharmaceutical and related industries with daily responsibilities in the following areas:

  • Analytical Development Laboratory
  • Quality Control Laboratory
  • Contract Laboratory
  • Quality Assurance

What’s included with the workshop?
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 been involved in the development of this topic since 2010

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.

Pauline 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 Apr-14, 2020 8:45 am
Course End Date Apr-15, 2020 5:00 pm
Registration Start Date Jan 29, 2020
Cut off date Mar 31, 2020
Individual Price $1,080.00
Course Leader Pauline McGregor, P.h.D.CChem MRSC
Location Fairfield Inn & Suites Toronto Airport Hotel
$1,080.00 10

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


  • 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.