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Best Practices for 510(k) Drafting and Submission

From this webinar you will learn best practices for adequately putting your 510(k) together for your successful submission to the FDA, compliant with the FDA

This session will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner. David will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared. This session is a must for regulatory professionals working in medical device industry including those who are interested in the topic.Areas Covered in the Session :Statute(s) and regulationsDefinitionsDevice classification and how to identify predicates: key factors510(k) program: when the requirement is of 510(K)Regulatory requirements510(k): requirements, contents and formatSubstantial equivalence: special considerationsThe task of addressing e-Copy and RTA policy requirementsSome of the common mistakes for RTA policy requirementsApplicable standards and guidanceCommon pitfalls and how to prevent them: dos and don’tsWhat to ensure while preparing for a 510(k) applicationResponse to FDA’s request of additional informationResolving some of the different opinions and interpretations: dos and don’tsSpeaker’s practical, actionable and sustainable solutions (PASS)Best Practices to achieve compliance and to stay compliant: dos and don’tsPASS-IT suggestions and recommendationsWho Will Benefit:Medical device quality and compliance professionalsPharmaceutical compliance professionalsQualityRegulatory affairsCEOsVPsAttorneysClinical affairsResearch & DevelopmentConsultantsContractors/subcontractorsAnyone interested in the 510(K) mattersPrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299


17 Oct 2014 @ 01:00 am

17 Oct 2014 @ 02:00 am

Duration: 1 hours

Timezone: GMT -5:00


Online Webinar

Organised by

Compliance Trainings (deactivated)

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