Do You Really Need To Do A Recall? If So, What Is Required?

Why Should You Attend:

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.

Areas Covered in the Webinar:

• 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?
• Examples
• Documenting the decision
• Documenting the recall process
• Q&A

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Regulatory roles
• Quality assurance management
• Manufacturing management responsible for executing recall activities
• Project managers and staff involved with recalls

Instructor Profile:

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.

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