2016 Webinar by Compliance4all on Investigational Device Exemption
- Start Date:
- Thursday, 1 December, 2016
- End Date:
- Thursday, 1 December, 2016 11:00am
- Health & Nutrition
Overview: An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Areas covered in the session:Learn the appropriate and expected regulatory strategies and guidelines for your IDEUnderstand the application process and administrative action with your IDEKnow the responsibilities of the sponsorIRB review and approval and expectationsWhat records and reports are expected and requiredIDE refers to the regulations under 21 CFR 812Know the procedures involved with the clinical studies and expectationsUnderstand that if the study involves a significant risk device, the IDE must also be approved by FDA Who will benefit: This webinar will provide valuable assistance and guidance to medical device firms that are currently preparing or will prepare for IDE submissions.
The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the IDE preparation and submission process, including:Regulatory AffairsClinical AffairsQuality and ComplianceMarketing & Sales Distributors/Authorized RepresentativesEngineering/Technical Services/OperationsConsultants Speaker Profile:David Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.
Contact Detail: Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.comhttp://www.compliance4all.com/Event Link : http://www.compliance4all.com/control/w_product/~product_id=500839LIVE?channel=mailer&camp=webinar&AdGroup=meetings4docs_Dec_2016_SEOTwitter Follow us - https://twitter.com/compliance4allFacebook Like us - https://www.facebook.com/Compliance4allLinkedIn Like us - https://www.linkedin.com/company/compliance4all
161 Mission Falls Lane,
Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- 161 Mission Falls Lane, Suite 216