Source: https://www.complianceonline.com/do-you-really-need-to-do-a-recall-webinar-training-703895-prdw?channel=am_trainingregistry
Timestamp: 2019-03-21 11:58:31
Document Index: 675293274

Matched Legal Cases: ['§806', '§806', '§7', '§806', '§7', '§806', '§7']

Do You Really Need To Do A Recall : Compliance Training Webinar (Online Seminar) - ComplianceOnline.com
Home › Online Training › Medical Devices › Do You Really Need To Do A Recall? If So, What Is Required?
Do You Really Need To Do A Recall? If So, What Is Required?
Product ID: 703895
This training program will provide practical pointers on documenting the recall decision. Recall can be a very costly process for a manufacturer. It is really important from a regulatory perspective to properly document the decision process whether a recall is necessary or not. The new guidance can help provide some direction in making the decision. Though guidance documents are not binding, they do tend to reflect the current thinking of the FDA. Beyond the guidance, the webinar will also illustrate best practices for documenting the recall process in the event that you determine a recall is warranted.
In October 2014, FDA published a new guidance entitled "Distinguishing Medical Device Recalls from Medical Device Enhancements". This guidance is intended to:
Clarify when a change to a device constitutes a medical device recall
Distinguish those instances from device enhancements that do not meet the definition of a medical device recall
Clarify reporting requirements under 21 CFR §806
The guidance should not be used alone but instead should be applied in conjunction with 21 CFR §806 and if applicable, 21 CFR §7, subpart c. This webinar will discuss the primary points of the new guidance, review 21 CFR §806 and i21 CFR §7, subpart c, as well as how to document your recall decision and what is needed if a recall is warranted.
Background of the new guidance
21 CFR §806
21 CFR §7, subpart c
When is a change a recall?
When is a change not a recall?
Documenting the recall process
Manufacturing management responsible for executing recall activities
Project managers and staff involved with recalls
Cheryl Wagoner has 20 years of experience in quality assurance, and regulatory affairs. She is currently the principal consultant/owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in quality, regulatory, clinical and compliance in the medical device and pharmaceutical industries.
Ms. Wagoner is a member of Regulatory Affairs Professionals (RAPS) and Medical Device Manufacturers (MDMA) FDA Working Group. She completed the RAPS Executive Development Program at the Kellogg School of Management.