We use cookies to personalise content and ads, to provide social media features and to analyse our traffic. We may also share information about your use of our site with our social media, advertising and analytics partners. Read more about our Privacy Policy.

I got it!

Event

Managing Product Corrections & Removals in Accordance with 21 CFR, Part 806

If your organization is struggling with understanding the salient requirements associated with 21 CFR, Part 806, this webinar is for you.

Description :Compliance with 21 CFR, Part 806 (Medical Devices; Reports of Corrections and Removals) is not optional for device manufacturers wanting to enter medical devices into commerce in the United States. Compliance is driven, in part, by recall classification (three device classes in the U.S.). The Recall Classification (1, 2, or 3), premised on risk, will drive the amount of oversight and reporting required by FDA. A medical device recall is always a challenging event for device manufacturers because it is an activity that hopefully is not called upon much. However, having a well-documented approach to managing recalls and employees that are appropriately trained are key in executing recalls successfully.If your organization is struggling with understanding the salient requirements associated with 21 CFR, Part 806, this webinar is for you. This webinar will help your organization better understand the FDA’s expectations for implementing an effective recall program, including tools needed to successfully execute product recalls including:(a) creation of a recall notification packet(b) product recovery and quarantine(c) reporting required by FDA(d) product rework and/or destruction(e) effectiveness checks(f) closing the recall.For establishments already having a compliant approach for corrections and removals, this webinar will help your organization streamline their approach to managing recalls effectively. Areas Covered in the Session :Reviewing and understanding the requirements associated with 21 CFR, Part 806 complianceRegulatory and statutory requirementsRecall classificationThe recall processNotifying FDACreating the recall notification packetNotifying customersProduct recovery and quarantinePeriodic reporting requirementsEffectiveness checksThird-party providersProduct disposition (rework and/or destruction)Closing the recallWho Will Benefit:Quality ProfessionalsRegulatory ProfessionalsRisk Management SpecialistsComplaint Managers and SpecialistsCompliance OfficersCustomer Service ProfessionalsSales/Marketing ProfessionalsSenior and mid-level Management21 CFR, Part 806, 21 CFR Compliance, Medical Devices, FDA, medical device recall, FDA, Compliance, Webinar

When

15 Oct 2015 @ 01:00 pm

15 Oct 2015 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Where

Online Webinar


Language

Englishen


Organised by

Compliance Trainings (deactivated)

Premium Events in Science

Other Events in Science

Similar Webinars in Science

Recent Publications in Science

Recent Videos in Science

Recent Speakers in Science

Krisztina Tóth
Senior Project Manager

19

Andras Guttman
Professor & Head

2

Sponsors in Science

Recent News in Science

Today we are joining humanitarians & experts from across the 🌍 at the virtual 𝙃𝙪𝙢𝙖𝙣𝙞𝙩𝙖𝙧𝙞𝙖𝙣 𝙉𝙚𝙩𝙬𝙤𝙧𝙠𝙨 & 𝙋𝙖𝙧𝙩𝙣𝙚𝙧𝙨𝙝𝙞𝙥𝙨… https://t.co/5eeo8OwSRZ

@EU_ScienceHub - 21 Apr 2021 09:05

microMesh is a microscopic polymeric network to attack glioblastoma multiforme with nanomedicine

@https://erc.europa.eu/content/micromesh-microscopic-polymeric-network-attack-glioblastoma-multiforme-nanomedicine - 20 Apr 2021 14:47

microMesh is a microscopic polymeric network to attack glioblastoma multiforme with nanomedicine

@https://erc.europa.eu/content/micromesh-microscopic-polymeric-network-attack-glioblastoma-multiforme-nanomedicine - 20 Apr 2021 14:47

Premium EventsLearn more ..