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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.

Preparing Your Company for the Medical Device Single Audit Program (MDSAP)

Geetha Rao (CEO, Springborne Life Sciences)

Location: 210D

Date: Tuesday, February 5

Time: 4:45pm - 5:30pm

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

The MDSAP auditing program has recently seen major spikes in the total number of participating manufacturer sites, which could be explained by Health Canada’s requirement that companies now be compliant. This requirement led to some scrambling among device makers to schedule audits in time, and despite the many tweaks implemented over the past year to facilitate the transition, many issues facing small to medium-size firms remain. This session will shed some light on the pilot program and explain how manufacturers can use it to their advantage.

Topics covered include:
  • Status of MDSAP and findings from the program’s three-year pilot
  • Best practices from companies that have gone through an MDSAP audit
  • How key requirements, like audit preparation, are being addressed
  • Effectively standardizing activities within the quality system to address different requirements