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New webinar series on the Enhanced Approach to Analytical Procedures 

Finally, ICH has published the revised draft ICHQ2 guidance and a new draft Guidance for the development of analytical procedures for public comment (ICH Q2/ICHQ14 Draft Guidance for public comment). If you are part of a small to medium size company or an individual, I am collecting comments to submit to ICH on these chapters. Please email me your thoughts and I will add them to my response. (email) or contact me at pmcgconsulting@sympatico.ca . It may help you to also read the new chapter published in the USP (General chapter<1220>) to help put the ICH guidance’s into perspective.

In light of the progress in this topic, I am running a new webinar series on the Enhanced Approach to Analytical Procedures. I look forward to you joining me and allowing me to help you on your journey toward achieving more robust and reliable analytical procedures.

Note:  All webinars are currently being delivered using a Zoom platform. If you are interested in a webinar and cannot access Zoom or Skype for Business, please contact us. 

Thanks to all who participated in one or more of the Social Brain Break sessions. They were lots of fun! Watch this space for the return of this popular event


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  • 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.