Top Compliance Trends for 483 and Warning Letters for 2012


Note: This Webinar covers topics relevant to both drugs AND devices.

FDA is more vigilant and aggressive than ever before with its 483 and warning letter enforcement procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant.

Now, in our unique 90-minute webinar, you can learn the detailed trends of 483 and warning letter for 2012. Our speaker, Dennis Moore, Managing Partner, AUK Technical Services, is a 28 year veteran FDA investigator. Dennis recently had unlimited and highly unusual access to FDA 483 and warning letter trend data from 2010 and 2011. He has assembled a presentation that reveals a level of detail of FDA trend data that you cannot find anywhere else.

We have never seen this amount of detail in any FDA data on 483s and warning letters – ever. We also have never seen so much detail on data this fresh. Anyone who deals with FDA data regularly knows that most of their released data is 4 years old. This data is only a year old!

A few things that you will learn in this 90 minute, detail-packed webinar:

The Top 10 QS 483 Observations for 2010 and 2011
The rising trend of ‘cease to market’ letters, one of which hit a NY pharma company in 2011
The total number of 483s issued in 2010 and 2011 – an all time high
Total CAPA 483 observations in 2010
483 inspection targets for 2010, 2011, and 2012
Total warning letters issued by device category in 2010
Which district offices write the most warning letters
How long to receive a warning letter, based upon issuing office
Warning letters issued by QS system for 2010
483s broken down by QS subsystem for 2010
Warning letters by CFR section
Top device 483 observations for 2010
Details on process validation observations for 2010
Design control 483 observations by category for 2010

It is very unusual to see this amount of detail in FDA data, especially data that is this recent. We have never seen it covered anywhere else. You will learn detailed, insider information on how FDA is thinking on 483s and warning letters. You can learn all kinds of details that can be a huge help to your firm when the next inspection rolls around.

About Your Speaker:

Dennis M. Moore is currently Chief Technical Expert and Managing Partner of Auk Technical Services LTD, Beverly Hills, CA. Mr. Moore has 28 years of experience in medical device design, software design validation systems and evaluations, manufacturing software validation including ERP systems and FDA Predicate rules and the 21 CFR Part 11 rules as they apply to device firm’s quality systems. Mr. Moore also has experience training drug and device firms in all aspects of device and pharmaceutical manufacturing and 21 CFR 210,211 quality systems. Mr. Moore has extensive experience helping firms achieve compliance to FDA regulation and International Standards regulations. Recent achievements include CE marking a medical device, helping create a Combination Product Quality System; co-authoring a Technical File submission, and achieving ISO 13485:2003 and ISO 9001:2008 certification for a medical device manufacturer.

Additionally, Mr. Moore has extensive experience as a Level II FDA Investigator, California Medical Device and Drug Team Senior Investigator, Sworn Government-POST Certified Criminal Investigator, Lead Trainer, Compliance Officer and company Chief Technical Expert and CEO.
Mr. Moore has given numerous web seminars on GMP issues; has traveled the world putting out FDA compliance related fires and authored many documents on quality system inspection, FDA/CA narrative report compilation, drug quality systems and software auditing techniques.

Mr. Moore is a member of RAPS, AAMI and is a former official with the State of California Medical Device Team. Mr. Moore also has RAB certification to the ISO 13485:2003 standard. Mr. Moore holds a BA degree in Zoology, with Graduate work in Toxicology and a Sworn POST certified Government Criminal Investigator peace officer badge.

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