Presented as a virtual conference via a web cast.  


About the Conference

Deficiencies in process validation and other aspects of production and process control earn more FDA enforcement actions than any other quality function except CAPA.  This two-day workshop addresses key issues in process validation, including risk-based determination of processes to be validated, FDA and 13485:2016 requirements, key process validation elements and best practices, statistical and other tools, maintaining the validated state, and documentation.

Who should attend:

  • Quality managers and engineers
  • Manufacturing managers and engineers
  • Validation engineers
  • Regulatory affairs
  • Compliance officers
  • QMS auditors

Topics will include:

  • FDA and global validation requirements and guidance documents
  • Risk management and process validation
  • Defining process key elements and parameters
  • Creating a validation master plan
  • Types of process validation
  • The use of equivalency in process validation
  • Statistical tools and methods
  • Maintaining the validated state
  • Evaluating and managing changes
  • Human factors validation
  • Inspections, audits, and typical process validation observations

Previous speakers at MedTech Intelligence programs on this topic include:

  • Kim Colasanti – Quality Assurance Manager, Welch Allyn
  • Anura Fernando – Principal Engineer – eHealth – Medical Systems Interoperability & Mobile Health, UL
  • Roberta Goode – President, Goode Compliance International
  • Eric Horowitz – Quality Systems Working Group Lead, Office of Compliance, CDRH
  • Jeremy Jensen – Principal Compliance Analyst, Boston Scientific
  • Christopher Kotsopulos – Consultant, Quality Systems & Regulatory Affairs
  • Yuan Li, PhD – Orthopedic Product Specialist / Auditor, Medical & Health Services, TÜV SÜD
  • George Omae – Senior Therapy Delivery Engineering Manager, Medtronic
  • Development, BD
  • Geoff Pascoe – Consultant, Health IT and Medical Device Interoperability and Security
  • Robert Ruppenthal – President, RTEmd
  • Donna-Bea Tillman – Senior Consultant, Biologics Consulting Group, former Director, Office of Device Evaluation, FDA
  • David Vogel – President, Intertech Engineering Associates
  • Steve Wilcox – Principal, Design Science

Attendees at previous conferences on this topic include:

  • DePuy Synthes – Sr. Quality Manager
  • ZOLL Medical – VP, Quality, Service, Regulatory Affairs
  • BD – Director, Quality & Regulatory Compliance
  • Intuitive Surgical – Clinical Development Engineer
  • Intuitive Surgical – Product Quality
  • Smiths Medical – R&D Engineer
  • Edwards Lifesciences – Director of Quality
  • CR Bard – Manufacturing Engineer
  • Varian Medical Systems – Program Manager for RA/QA
  • DePuy Synthes – Sr. Research Engineer
  • Medtronic Diabetes – Engineering Manager
  • Philips Healthcare – Sr Manager, Verification & Validation
  • HeartWare Medtronic – Principal Electromechanical Engineer
  • bioMérieux – Sr Director, Global Quality Systems
  • Terumo Medical – Regulatory Affairs Manager
  • Medtronic – Sr Principal Test Engineer
  • Baxter Healthcare – Sr. Principal Engineer
  • Flextronics – VP, Global Quality & Compliance

CEU Information

Attendees can earn CEUs. 1 hour of the conference = 1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.

Details

  • When

  • Tuesday, January 29, 2019 - Wednesday, January 30, 2019
    10:00 AM - 4:00 PM

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