How To Survive Your Next FDA Inspection – Survival Guide Tips and Techniques – Oct. 2, 2015, 2 PM EST | Moore

How To Survive Your Next FDA Inspection – Survival Guide Tips and Techniques – Oct. 2, 2015, 2 PM EST | Moore

January 2nd, 2015 // 7:48 pm @

 



Webinar Preview!

How The Quality Manager Gets Fired, aka The $50,000 Compliance Mistake: 

You’ll learn about this in the Webinar below, but here’s a hint – You have 15 days to respond to a 483, or else! Miss the deadline, and your FDA 483 response is for naught! It sounds obvious, but this huge costly mistake trips up pharma companies all the time. Sign up for this great webinar for much more fascinating compliance information.

What You Will Learn In This cGMP Inspection Webinar

FDA is more vigilant and aggressive than ever before with its cGMP  inspection procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant.

In this comprehensive Webinar by Dennis Moore, Chief Technical Expert and Managing Partner of Auk Technical Services LTD, you will learn absolutely everything you need to know to survive and prosper in your FDA inspection that is focused on cGMP regulations.

Rare Information! – Moore has much rare FDA data at his fingertips- For example, did you know that there are aggressive FDA District Offices, and comparatively lax FDA District Offices? Dennis will tell you which offices are the most and least aggressive, which can give you an idea on the best place to locate your company.

He also will provide strategies that you can use to reduce your firm’s exposure to aggressive FDA District Offices that issue the most warning letters.

And, learn how one mistake with your FDA 483 response can easily cost you $50,000 in wasted consultant fees!

Also, he will discuss which District Offices have the most and least difficult inspectors for a given specialty area.

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.

What You Get Free:

  • Powerpoint Slides to Print Out and Share
  • CD Recording and Download Recording of the Presentation – Share With Colleagues!
  • Free Report #1 -How to Meet Compliance and Records Requirements of the US Food and Drug Administration, by John Avellanet, President, Cerulean Associates LLC
  • Free Report #2 – Are ‘Land Mines’ Hiding in Your Supplier Records?, by John Avellanet, President, Cerulean Associates LLC
  • Free Report #3 -Rapid Deployment Tips to Prepare for an FDA Inspection Quickly, John Avellanet, President, Cerulean Associates LLC

Topics to be covered include:

  • Which District Offices Are the Most and Least Aggressive in Terms of 483 and Warning Letter Issuance?
  • Which District Offices Have the Most and Least Aggressive Inspectors for Certain Drug and Device Specialties?
  • What Mistake in Your 483 Response Can Cost You $50000 in Wasted Consultant Fees
  • Who Is Responsible For What?
  • The Crucial First 15 Minutes
  • What The FDA Can and Cannot Do/See
  • How to Answer Questions and to NOT Answer Questions
  • Your Responses – Less Is More
  • SOP Landmines
  • Special Circumstances
  • Close Out Meeting

You also will learn the details about all of the types of inspections FDA may perform:

  • Initial Inspection
  • Manufacturing Facility Inspection
  • Recall Follow Up
  • Full Quality System Assessment
  • Pre-PMA
  • Problem-Related
  • QSIT

Dennis will cover what you should be doing before the inspector arrives, such as doing department shakedowns, dealing with CAPAs and QSR review and more. He also will tell you what you should do when the inspector arrives, such as it is important to never leave the FDA auditor alone.

Also, you will learn what to do if the inspector protests your banning him or her from recording the audit. Also, learn:

  • Which FDA District Offices Are Most Difficult/Easiest to Deal With
  • What the Inspector Can Do and Not Do
  • What the Inspector Cannot Inspect
  • How to Make a Great Impression in the First 15 Minutes
  • Tricks That Inspectors Love to Use Against You – The Silent Treatment
  • What You Have to Know About SOPs
  • Why You Should Request Daily Meetings
  • Tips for 483/EIR Responses and Follow Up
  • Why You Should Communicate Openly With FDA Afterwards

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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