FDA 483 Aftermath – How Should You Respond? | March 20, 2014, 2 PM EST | Dennis Moore
February 27th, 2013 // 5:14 pm @ jmpickett
FDA is more vigilant and aggressive than ever before with its cGMPÂ 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 how you should respond in the aftermath of an FDA 483. 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.
What You Will Learn in This FDA 483 Webinar:
- Importance of responding to 483 in 15 business days.
- FDA has no obligation to warn you further after 483 – sanctions can occur any time
- If you ignore FDA, agency can seize all equipment and records (case study cited)
- Why you should get arrogant with FDA. Most pharma firms are not Google-funded and FDA won’t bow to you.
- Why you should not argue in the close out meeting – cave, and respond in the 483 response letter.
- Why you should be careful to committing to anything in the close out.
- How to rehab your reputation with FDA in the response
- Who should write the response?
- What is High-level management’s Role.
- How to write a cover letter or opening statement.
- How to re-state the observation and reference number in the response.
- How to leverage compliant areas within the firm
- Pit falls of stating corrective actions have already taken place
- Learn how to show FDA how enhancements will prevent recurrence of the issue observed
- Learn how to show FDA how training will occur and enhance the response letter effectiveness
- Learn how to show FDA how you will monitor the progress and effectiveness of the corrective actions.
What You Get Free
- Samples of an actual response letter in Word 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
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.
