URGENT PANDEMIC INFORMATION

In light of the pandemic situation all of our 2021 events are cancelled. We will inform customers directly when the events are rescheduled.    
COVID CANCELLED: Project Management in Human Resources,   Boston MA, Jan 6-8, 2021
COVID CANCELLED: InterDrone, The International Drone Conference,   Cambridge MA, Jan 11-13, 2021
COVID CANCELLED: Supplier Management for Medical Device Manufacturers,   Cambridge MA, Feb 2-4, 2021
COVID CANCELLED: US Immigration Compliance Strategies,   Boston MA, Feb 15-18, 2021
COVID CANCELLED: Project Management Training,   Boston MA, Mar 3-5, 2021
COVID CANCELLED: Internal Audit, Fraud Risk Assessment Workshop,   Boston MA, Mar 22-25, 2021
COVID CANCELLED: Agile / Scrum Training,   Boston MA, Apr 12-14, 2021
COVID CANCELLED: Validation, Verification and Transfer of Analytical Methods,   Boston MA, Apr 19-21, 2021
COVID CANCELLED: Computer System Validation - Reduce Costs and Avoid 483s,   Boston MA, May 10-12, 2021
COVID CANCELLED: SharePoint Technology Conference,   Boston MA, May 26-28, 2021
COVID CANCELLED: Employment Laws Certificate Program,   Boston MA, Jun 7-9, 2021
Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .    
TENTATIVE: 21 CFR Part 11 Compliance,   Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance,   Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation,   Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021,   Boston MA, Dec 7-9, 2021

Boston Professional Events List


Live Webinar Construct and Manage the Technical File and Design Dossier


Date
Jun 14, 2021 - 01:00 PM - Jun 15, 01:00 PM
Organizer
conference Manager
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
FL,
US,
ZIP: 33021
Phone: 347 282-5400

Ticket Price: $179 One Dial-in One Attendee | Corporate Live Recorded $279 One Dial In - Max 10 attendees |Group $695 Multiple locations upto 5 dial in | Recorded $249
This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details everything about your medical device. Understanding how to assemble this information and present the information properly is essential. If you manufacture a Class I device, a less complex CE Marking Technical File may be required. In the case of Class IIa, IIb and Class III devices, a more complex CE Technical File or Design Dossier must be prepared. EU Technical File construction is subject to review by a Notified Body if the medical device is Class I with measuring or sterile function, Class IIa, IIb, and III (Design Dossier).
 

Areas Covered

 

•      Learn the differences between the Tech File and Dossier and why the construction phase is so important
•      Compile the EU Technical File or Design Dossier and ensure Format and Content expectations are addressed appropriately
•      Understand why Design Dossier is viewed as a subset of the Tech Documentation with emphasis on “design”
•      Determine exactly which materials need to be assembled
•      NB must examine the application for examination of the design dossier and, if the product conforms to the relevant provisions of the Directive, issue the application with an EC design-dossier certificate
•      Review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s)
•      Determine applicable standards and address company-specific SOPs for constructing and managing your files
•      European Norms and Standards and other documents supporting Technical Files and Design Dossiers
•      Guidance on Design-Dossier Examination and Report Content

 

Who will Benefit

 

This webinar will provide valuable assistance and guidance to medical device companies responsible for constructing and managing their Technical Files and Design Dossiers. Employees who will benefit include: 

•     All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview; however, it is assumed that customers/attendees have some prior MDD and CE Mark background as applicable
•     Regulatory Affairs/Regulatory Affairs Specialists
•     Clinical Affairs
•     Quality and Compliance
•     Marketing & Sales 
•     Distributors
•     Engineering/Technical Services
•     Consultants



Speaker Details


Speaker Profile


David R. Dills, Global Regulatory Affairs & Compliance Consultant, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts regulatory and compliance assessments. 

Event Categories
Keywords: Education




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