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Finally, ICH has published the revised draft ICHQ2 guidance and a new draft Guidance for the development of analytical procedures for public comment (ICH Q2/ICHQ14 Draft Guidance for public comment).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
Session 6: Analytical Procedures: Qualification, Monitoring and Changes (Stage 2 and 3 lifecycle approach)
Note: In order to benefit from the application of Stage 2 and 3 as described in this webinar, analytical procedures should have been developed (or assessed in the case of transfer/verification) using the QbD principles described in Session 5. (Stage 1)
Webinar outline
This 2 hour webinar includes the following:
- Setting up the qualification study
- Using knowledge from Stage 1
- Experimental design
- The Protocol and acceptance criteria
- Evaluating the data and final report
- Monitoring the performance of the procedure
- Handling change
Who Should Attend?
This Webinar is valuable for anyone interested in Validating their analytical procedures via the lifecyle 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 | Jun-23, 2022 9:00 am |
Course End Date | Jun-23, 2022 11:00 am |
Cut off date | Jun-22, 2022 12:00 pm |
Individual Price | CDN245.00 |
Course Leader | Dr. Pauline L McGregor CChemMRSC |
Location | Virtual |