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Webinar On Key Regulatory Documents

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier

Description : This 90 minute webinar will examine the existing and proposed requirements for the U.S. FDA's DHF and the EU MDD's TF/DD. This webinar will provide valuable assistance to all regulated device companies that need to ensure their DHFs, TFs/DDs and associated and derivative documentation meet their respective requirements. It also addresses current requirements as well as some changes on the horizon.Areas Covered in the Session :How to meet and document their differing requirements.Required and desirable contents.Areas requiring frequent re-evaluation / update.Similiarities and differences, and future convergences and trends.Typical DHF contents.Typical Technical File or Design Dossier contents.The importance and usefulness of the "Essential Requirements".Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed.Parallel approaches to development.Where the Device Master Record / Device History Record "tie in".Differing approaches to records audits by the U.S. FDA and an EU Notified Body.Who Will Benefit:The employees who will benefit include:Senior managementMiddle managementR&DEngineeringSoftwareQA / RAManufacturingOperationsConsultantscGMP instructorsAll personnel especially involved in device development, regulatory compliance and documentation.Price Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458 


24 Feb 2015 @ 01:00 pm

24 Feb 2015 @ 02:30 pm

Duration: 1 hours, 30 minutes

Timezone: GMT -5:00


Online Webinar

Organised by

Compliance Trainings (deactivated)

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