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Blue Sky Approach - Down to Earth Solutions

 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

Enhanced Approach Versus Traditional Approach for Analytical Procedures. What’s the Difference?

This webinar summarises and discusses the differences between the two approaches. 

The objectives of the webinar are:

  • To highlight key concepts and strategies of the enhanced approach for analytical procedures 
  • Put them in context and compare them to the traditional approach.
  • Summarise some of the challenges and benefits of the enhanced approach
  •   Help you start your journey towards using more robust analytcal procedures.

This 3 hour webinar provides a useful platform to succinctly present the key concepts and differences of the two approaches and help you get started on your journey towards developing/transferring more robust analytical procedures. 
In view of the pending new guidance, ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation, due for publication next year, its time to find out what the differences are.

Webinar Outline

  •  Introduction
  • Overview of Traditional approach
  • Why change? Problems experienced using the traditional approach
  • Overview of Enhanced Approach
  • Key Concepts and Strategies
  • High level differences
  • Differences in more detail and comparisons
  • Challenges and benefits of the Enhanced Approach
  • Q and A session

Who Should Attend?

This Webinar is valuable for anyone involved in developing, validating, transferring or verifying analytical procedures for the testing of pharmaceutical materials and would like to know more about the enhanced approach for analytical procedures, how it is different from the traditional approach and how ito improve the performance 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 analytical procedures, quality systems and GMP regulations.

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 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-10, 2020 9:00 am
Course End Date Nov-10, 2020 12:00 pm
Registration Start Date Oct 14, 2020
Cut off date Nov 09, 2020
Individual Price $345.00
Course Leader Pauline L. McGregor, Ph.D. CChem, MRSC
$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.