Enclosed are a series of upcoming microbiological webinars which are being offered between now and the end of September. While many of us are working from home or in the office on a limited basis, this represents a great opportunity to either gain new skills or refresh those that may require refreshing. Just click on the title of each webinar to gain additional information or … [Read more...]
Microbiological Webinars 2020 (Upcoming)
Enclosed are a series of upcoming microbiological related webinars which are being offered between now and the middle of June. While many of us are working from home or in the office on a limited basis, this represents a great opportunity to either gain new skills or refresh those that may require refreshing. Just click on the title of each webinar to gain … [Read more...]
Guidance for Industry. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients – Questions and Answers. June 2015
In June 2015 ICH issued a Q & AÂ Guidance document that complements the Guidance for Industry Active Pharmaceutical Ingredients, ICH Q7. 2000. Since 2000, experience with implementing the guidance has created a need for clarification of various sections. ICH Q7 should be applied in combination with the principles laid down for development and manufacturing in … [Read more...]
THE FDA AND TurboEIR – HOW IT’S MANAGED AND MISMANAGED FORM FDA 483s
TurboEIR is a FDA software program designed to standardize Form FDA 483s and Establishment Inspection Reports (EIR). It was completely “rolled out†in October 2002. For each “Objectionable Condition†(FDA 483 Observation), TurboEIR requests the inspection team to choose a … [Read more...]
FIND FDA WARNING LETTERS AND RECALLS THAT DISCUSS THE LATEST REGULATORY THOUGHTS
USE “KEY WORDS’ THAT PROVIDE FOCUSED SEARCHES Barry A Friedman, PhD has been publishing a variety of Regulatory Actions including information regarding Warning Letters, Recalls, and other regulatory activities for over three years. These 140+ Regulatory Actions often include FDA related activities that are not readily found within the FDA … [Read more...]
