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 Check out the interactive, knowledge sharing industry webinars during November and December 2020!

Unfortunately all in-house training sessions have been cancelled for the remainder of the year due to the Covid -19 pandemic

Contact us to customize an interactive and discussion format webinar to suit your company's training needs

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

Laboratory Transfer and Verification of Analytical Procedures - Integrating Future Philosophies into Current Practice

Many analytical procedures which require transfer / verification come to us with inherent problems. These don’t magically disappear during transfer or verification process but instead can cost us a lot of time, money and effort to resolve issues, either at the time of transfer or in routine use. We may get lucky if we use the best of everything (equipment, analyst etc).  Although this may seem the best chance of success to tick that compliance box, it is not good science as it does not challenge the test procedure. Also, we tend not to test sufficient samples or even the correct samples in order to challenge future performance. 

The exercise to qualify our method in our laboratory for routine use is often viewed as something that has to be done to check a compliance requirement. We need to change our way of thinking towards this exercise and bring back the science! It helps when we recognise that this exercise provides a great opportunity to understand the procedure, include any validation deficiencies and additional controls and really challenge it. In other words, address the fear of failure head on with knowledge, understanding and good science, rather than cross our fingers and toes and hope we get through it first time! Identifying and addressing the issues as part of the transfer/verification process will set the procedure up for success throughout its lifecycle.

In this 3 hour webinar, modern concepts such as QbD philosophies i.e risk assessment and method understanding are combined with our current practices to ensure a smoother method transfer process, a more robust performance, leading to fewer lab incidents/OOS results due to poor procedure perfomance in routine use.

 Who should attend

Analytical Chemists, Supervisors and Managers involved in the technical transfer or verification of analytical procedures

What’s included with the webinar?

Each participant will receive:

  • A certificate of attendance upon completion 
  • An electronic copy of the presentation 

Course Leader

Pauline McGregor, PhD. CChem MRSC has fulfilled a variety of roles in over thirty years 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.

Her current passion is Lifecycle Management of Analytical procedures and application of QbD philosophies to improve method robustness. She has been involved in the evolution of the application of this topic since 2010.

As a USP volunteer, Pauline was a proud member of the initial USP expert panel for Validation, Verification and Transfer of Analytical Procedures and a member of a USP Chemical Medicines Monograph expert review committee. She continues to be a USP expert volunteer Pauline is also a member of The Royal Society of Chemistry, UK and is listed on their current directory for consultants.

 

 

Course Properties

Course Date Nov-24, 2020 9:00 am
Course End Date Nov-24, 2020 12:00 pm
Registration Start Date Nov 02, 2020
Cut off date Nov 23, 2020
Individual Price $345.00
Course Leader Pauline L. McGregor, P.h.D. CChem MRSC
This course is currently not available:  Notify Me When a Course is Scheduled
$345.00 100

Have you considered a customised, interactive and discussion format webinar? Contact PMcG Consulting directly for your in-house training needs.

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.