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2016 Webinar by Compliance4all on Product Risk Management Under ISO 14971

Start Date:
Wednesday, 7 December, 2016
End Date:
Wednesday, 7 December, 2016 11:00am
Health & Nutrition

Overview: Drug master files serve as documentation on the quality of an active ingredient or excipient and are submitted by a manufacturer as part of the licensing or amendment procedure. Confidential information from the manufacturer must be protected. However, at the same time the license-holder must receive all the information it needs in order to takeresponsibility for the quality of a medicinal product. Areas Covered in the Session:Examine the background and history with the EDMFLearn step-by-step how to construct and submit the EDMF (and this is not FDA's DMF)DMF†s today are mostly prepared following the rules of Common Technical Documentation (CTD)Understand that this is a document containing the information required to demonstrate that the quality of the active substance is adequately controlled by the specification proposed by the applicantExpectations for Applicant's part and ASM Restricted Part of the EDMF Who will benefit: This webinar will provide valuable assistance and guidance to manufacturers who must prepare and submit the Drug Master File (Active Substance Master File) to European Competent Authorities.

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 EDMF process and expectationsRegulatory 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.com Link : Follow us - Like us - Like us -


161 Mission Falls Lane,
Suite 216

Organizer Details

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

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