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Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel

 
  November 03, 2010  
     
 
GlobalCompliancePanel, Online Training
2010-12-02


Overview: 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). Once placed on the market, national Competent Authorities have the right to review EU Technical Files regardless of classification at any time. An incomplete or improperly completed Technical File may result in unexpected delays or even prevent market entry. Whereas the expression "Technical File" is usually associated with Class I, IIa and IIb, and "Design Dossier" for class III products., the files are retained on the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body. Dossiers have to be submitted to the Notified Body for review prior CE-Marking of your product. It is not necessary to include all documents in the design dossier which have already been subject to an ISO/MDD type Audit by the Notified Body. Examples of documents not necessary to be included are Quality Manuals and related lower-level documents. A brief summary of manufacturing processes (flow chart including inspection and preventive monitoring steps) and validation of sterilization processes should be included in the design dossier. Be prepared to review all elements that comprise these documents and address recommended best practices.

Areas covered in the session:
  • 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
 
 
Organized by: GlobalCompliancePanel
Invited Speakers: David R. Dills, Indpendent Regulatory & Compliance Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change. Prior to joining the consultancy Mr. Dills has provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA/Quality Systems, Regulatory Affairs/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers.

Mr. Dills areas of interest and expertise include executing process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW Validation/IT Network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI Inspections, product registration, J-STED/Ninsho activities, and training.

Mr. Dills currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He serves on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.

Mr. Dills academic degrees include Environmental Science and Biology. He currently serves as Advisor for the ASQ's Section 1506 and as a former Chair and Co-Chair and is an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.
 
Deadline for Abstracts: 2010-12-02
 
Registration:
Thursday, December 2, 2010  
10:00 AM PST | 01:00 PM EST
Live live online training only for one participant
Price: $245.00
 
 
 
Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care)
Price: $995.00
 

Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Price: $295.00
 
E-mail: webinars@globalcompliancepanel.com
 
   
 
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