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

Unfortunately, all in class training programs and workshops have been cancelled due to the COVID 19 out break. Please observe your local governments advice to keep you and your families safe and healthy.
Changes to PMcG operations until the COVID-19 situation is resolved: 

1) Reduced rates on online or telephone consulting sessions
2) Discounted document writing and review service
3) New Professional webinars to help increase efficiency of your operations/processes 
Contact us for a customised quote for the above services.

Check out our interactive knowledge sharing industry webinars during April and May!

 

Start your week on a positive note and give your brain a boost!  Sign up and drop in every Monday from April 27th through May 18th. We hope to boost those grey cells, make you laugh and not feel so alone! 10.00am EDT (Duration approx. 20 minutes).

Everyone is welcome!  Last Session May 18th.- It's a Brain Blast!

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

Unfortunately, a webinar cannot replace a 2 day workshop that includes case studies and practical exercises as well as a greater amount of knowledge sharing and discussion. However, it does provide a useful platform to succinctly present the key concepts and differences of the two approaches. 
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 testing of pharmaceutical materials and would like to know more about the enhanced approach for analytical procedures and how it is different from the Traditional approach

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 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.

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 and is on their current directory for consultants.

Course Properties

Course Date May-19, 2020 11:00 am
Course End Date May-19, 2020 12:30 pm
Registration Start Date Apr 09, 2020
Cut off date May 18, 2020
Individual Price plus HST
Course Leader Dr. Pauline McGregor, Ph.D. Chem, MRSC
This course is currently not available:  Notify Me When a Course is Scheduled
$255.00 100

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

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.