Tuesday, January 13, 2015

US FDA launches overarching Office of Pharmaceutical Quality - iPT

Read the full article: US FDA launches overarching Office of Pharmaceutical Quality - iPT:

"Within the OPQ, the agency will create an Office of Surveillance, which will be tasked with creating new quality metrics, and will let OPQ inspectors know if they need to inspect manufacturing facilities during an NDA (new drug application) review.

After a new industry range of metrics is published, she added that FDA will take “the first two years to make sure we’re measuring apples and apples” and allow facilities to see where they stack up against competitors.

The agency will undergo the “same type of work but new inspection protocols will be” standardized and help industry understand how pre-approval and surveillance inspections can be done, Woodcock said."

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Friday, January 2, 2015

New! - 2017 GMP QSR cGMP Training Course Catalog - by SkillsPlus Intl Inc.

Updated:  November 4, 2016

Get ready for 2017 cGMP QSR GMP training
  1. Are you planning your CGMP training schedule for 2017? 
  2. Do you wish you had more instructors?
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If you answered yes to any of the questions above, then take a look at our current list of classes, courses, workshops, and seminars that we can bring to your plant site.

View our catalog:  
2017 Course Catalog - FDA cGMP QSR GMP Training - Classes, courses, workshops, and seminars (PDF)

If you don't see what you need, just give us a call at (415) 948-5220.


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FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014 - AssurXblog

View the chart & read the full article:  FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014 - AssurXblog:

". . . FDA 483 Inspectional Observations for Fiscal Year 2014. 483s increased in foods from the prior fiscal year to 2476, an increase of 3.8%. However, medical devices and drugs were down -11.6% and -6.5%, respectively, from FY 2013. Interestingly, medical device 483s bucked their recent upward trend with the lowest number of observations since FY 2009."

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