PMcG Consulting Blog Page

Check back here for the latest posts from company founder, Pauline McGregor

How much do you really know about the Enhanced Approach and Lifecycle Management for Analytical Procedures?

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...
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Evening Discussion Group Enhanced Approach for Analytical Procedures

We want to hear the voice of industry
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...
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Tips for Success in 2019

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...
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Is Your Training Effective?

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 ...
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