Welcome to PMcG Consulting
Blue Sky Approach - Down to Earth Solutions

"I can recommend Pauline’s workshop 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

03
Jun
2019

Jun 03, 2019 9:00 am - Jun 04, 2019 4:30 pm
BioCity Glasgow
BioCity Glasgow
BioCity Glasgow, Bo'Ness Road, Newhouse ML1 5UH, United Kingdom

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Location:  BioCity, Scotland, UK. Save the dates June 3rd and June 4th 2019 Take advantage of the early bird discount by May 17th

Are you ready for ICH Q14: Analytical Procedure Development and the revision of ICHQ2(R1) Analytical Validation? These guidance’s, intended to be published by 2021, complement Q8 to Q12 and aim to improve regulatory communication between industry and regulators to facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.

The enhanced approach holistically manages analytical procedures throughout their lifecycle.
It not only focuses on value added activities to development but also leads to higher success rates when applied to the transfer and verification of analytical procedures. It also integrates the management of procedures into current quality systems to ensure ongoing acceptable performance of procedures, regardless of the end user location.

Benefits/advantages to attending this course are:

  • Improve performance of analytical procedures
  • Improve understanding of your analytical procedures
  • Reduce the number of OOS results due to poor method performance
  • Increase success of transfer or verification analytical procedures
  • Reduce non-value-added activities during investigations, development, verification and transfer 
  • Improve knowledge transfer and communication
  • Keep up to date with best practices and guidelines for analytical procedures
£995.00 12

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.