PMcG Consulting Blog Page

  This topic is gaining momentum in the industry with the pending revisions to ICHQ2 and new chapter ICHQ14 targeted for public comment later this year. When applied properly, the enhanced approach to analytical procedures results in improved performance throughout the life of its use. However, as with anything worth having, it comes with a pr...

​I recently recorded a podcast on the topic of Lifecycle Management for analytical procedures with the Waters team.  It was so much fun to speak on my favourite topic.  Thank you to Josh Gottschling  for being the best techie ever and to Larry Hines  for his support and intro. Also a big thank you to Isabelle Vu Trieu ...

Read the statements below to find out. If you want to learn more, register for the 2 day training course. Toronto and Scotland, UK dates now available.   1) The ATP (Analytical Target Profile) lists the range over which the method parameters are validated. Answer: False The ATP as described in the enhanced approach for analytical procedures de...

Evening Discussion Group – Enhanced Approach for Analytical Procedures. Feb 05, 2019 6:00 pm -9:00 pm, Radisson Suite Hotel Toronto Airport SPACES ARE LIMITED SO PLEASE REGISTER Please click to register or for more information ICH has recently formed two new working groups: Q2 (R2)/Q14: Analytical Procedure Development and Revision of Q2(R1) Analyt...

H ave a Data Integrity System in place. Remember real time documentation, traceability and security of your data is important. A nalytical methods - Consider incorporating some QbD concepts to achieve more robust performances. P eople- Trust your people! Challenge yourself to determine the systematic root cause that will alleviate human error rathe...

Training should be considered as an investment in your people and your company which leads to knowledgeable, staff and efficient, consistent processes which ultimately leads to compliance with regulatory expectations. Currently, many pharmaceutical companies have this backwards. My pet peeve when reviewing the root cause of quality incidents is to ...

When was the last time you stopped to smell the roses? Although this statement has become a cliché there is a lot to be said for it. With all of the technology available to us in the 21st century we can make ourselves available for communication 24/7, and most of us have been drawn into this lifestyle. We have become used to global timelines and pu...