Construct and Manage the Technical File and Design Dossier

David R Dills
Instructor:
David R Dills
Duration:
60 Minutes
Product Id:
500808
Access:
6 months

More Trainings by this Expert

Price Details
$190 Recorded
$390 Corporate Recorded
Price Detail Options
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.

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


Speaker Profile
David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry.

He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM's/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations.

Mr. Dills most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products.

David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk.

He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.


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