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Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

How Smaller Companies Can Use FDA’s Case for Quality to Reduce Costs & Inefficiencies

Stephanie Fossat-Dominguez (Vice President, Operation, CeloNova BioSciences, Inc.)

Allison Komiyama (Principal Consultant, AcKnowledge RS, LLC)

Location: 210D

Date: Wednesday, February 6

Time: 2:00pm - 3:00pm

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

Medical device manufacturers can reduce costs and increase profits by focusing on quality measures during medical device design and production. This quality improvement approach pays dividends in customer satisfaction and provides significant competitive advantages. The Case for Quality program helps FDA and manufacturers reduce certain widespread or common manufacturing risks that impact product quality. In this session, experts will discuss the Case for Quality program, insights from pilot program participants for smaller companies, and how it can be used to manufacturers’ advantage.

Topics covered include:
  • How the program benefits practices ranging from design improvements to controlling production errors while increasing speed of detection for quality issues
  • What is the process for getting involved in the program and what are the required resources?
  • The Quality Program Pilot Framework and how its modifications can increase a quick review for the 30-day notice of change
  • Identifying risk and mitigation strategies that are easily implemented
  • Case examples demonstrating quality improvements realized through the program

Presentation Files

How_Smaller_Companies_Can_Use_FDAs_Case_for_Quality_to_Reduce_Costs__Inefficiencies_.pptx
How_Smaller_Companies_Can_Use_FDAs_Case_for_Quality_to_Reduce_Costs__Inefficiencies_2.pptx