Damage Control! How to Handle an FDA Drug or Device Recall – June 12, 2 PM EDT – Moore

Damage Control! How to Handle an FDA Drug or Device Recall – June 12, 2 PM EDT – Moore

March 20th, 2022 // 3:24 pm @ jmpickett

In June, you have the unique opportunity to learn about how to avoid and manage FDA recalls from Dennis Moore, a former Level II FDA Investigator in our 60-minute GotoWebinar. The question of whether Food and Drug Administration (FDA) regulated products must be reported to the agency comes down to the type of product and the hazard it poses . While nearly all recalls are voluntary, the FDA has the authority to order recalls of medical devices.

This unique Gotowebinar on May 12, 2 PM EDT will help your firm understand these vital recall points:

1. Manage non conformances that may lead to recalls
2. Understand 21 CFR 806, which governs corrections and removals
3. What is the difference between a correction and a recall?
4. Understand the role of the HHE (health hazard evaluation)
5. Timing is critical in communicating with FDA
6. Understand recall classifications
7. How do I close the recall?

Related news story: How Pharmaceutical Packaging Mistakes Can Lead to Product Recalls

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.