Maintaining a Sustainable and Compliant Design Validation System and Using FMEA for Device Manufacturers

It will also include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, must be documented in the company’s Design History File or known as the DHF. Whereas verification is a detailed examination of aspects of a design at various stages in the development, design validation is a cumulative summation of all efforts to assure that the design will conform to user needs and intended use(s), given expected variations in components, materials, manufacturing processes, and the use environment.

Areas Covered in the seminar:

• Learn how to use a design FMEA to support that you did use risk analysis during design and development.
• Design validation is not process validation: did we design the right product?
• Understand the components of validation planning, review, methods and all of the required documentation.
• Why design control does not end with the transfer of a design to production.
• Why it encompasses verification and extends the assessment to address whether your devices produced in accordance with the design actually satisfy user needs and intended uses.
• Why FDA will take a "hard look" at design validation.
• Identify what goes into your design validation procedure to make it bulletproof.
• Understand and apply real life examples of risk analysis or hazards analysis tools such as FMEA.

Who Will Benefit:

This webinar will provide valuable assistance and guidance for medical device companies to ensure they have a well defined, deployed and enforceable design validation program. The employees who will benefit include:

• All levels of Management for all departments and those who desire a better understanding or a "refresh" overview.
• QA/QC/Compliance/Regulatory Affairs
• Marketing & Sales
• Design Engineering/R&D/Technical Services
• Consultants
• Operations and Manufacturing

Instructor Profile:

David R. Dills, Industry Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change within SCOPE (Strategic Compliance & Operational Excellence). 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. Mr. Dills also served as Director of Publications, Regulatory & Compliance for the Institute of Validation Technology. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA, Quality Engineering, Validation, RA/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers in conjunction with marketing and business development responsibilities.

Key areas of focus include product development and commercialization strategies, regulatory classifications, applications and submissions, regulatory and clinical consulting, rapid regulatory crisis response, involved in consent decree/CIA activities, improve and remediate quality management systems and documentation, inspection readiness preparedness for manufacturers and serves in an Expert Witness capacity for a third party. Mr. Dills has prepared and executed effective paths to obtaining approvals, worked effectively across functions for overall corporate compliance, and aligned GxP compliance in a fashion that supports a company’s business strategies and goals.

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, sample accountability, and other related functions and tasks.

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.

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