Internal Auditing Using the MDSAP Model - Webinar CD/Transcript

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Internal Auditing Using the MDSAP Model

Do you want to be one step closer to getting your product on the international market?

Consider implementing the Medical Device Single Audit Program — MDSAP.

It’s a single audit of your quality management system and satisfies the medical device regulatory authorities. And it doesn’t matter if you have full-time or part-time auditors.

Susan Reilly will teach you how to build and implement a highly effective, independent internal audit program including:

  • How to conduct an audit covering the standards and regulations addressed under the MDSAP model
  • How to identify and understand the requirements as interpreted by the various regulatory authorities
  • How to determine gaps in your current documentation
  • How to “score" your current quality system

Order today and get your MDSAP up and running.

  • Medical device manufacturing and executives
  • Auditing and compliance officers
  • QA/QC managers and directors
  • Production managers
  • Production supervisors
  • Process development staff
  • Auditing and compliance officers
  • Training managers
  • Regulatory affairs professionals
  • Executive management
  • General/corporate counsel
  • Personnel new to the industry

Susan Reilly, President & Principal Consultant, Reilly Associates LLC
Susan Reilly has more than 25 years of quality system, quality engineering, and regulatory compliance experience in the medical device area. Her company provides practical and cost-effective quality and regulatory consulting services to ensure conformance with FDA regulations, EU requirements, Canadian requirements, and ISO Standards.