Medical Device Single Audit Program (MDSAP) - A New Face of Audit
Duration : 60 Minutes
Parul Chansoria, RAC,
Parul is a Medical Device Professional with successful experience in initiation & implementation of Quality & Regulatory activities for different phases of a medical product life cycle (Design – Validation & Verification – Clinical & Non-Clinical testing – Regulatory approval & Clearance Read more
MDSAP is a new step towards audit harmonization for quality systems compliance of companies looking for marketing authorizations in Australia, Brazil, Canada, Japan, and the United States.
Course Objectives:
• What is MDSAP?
• MDSAP Audit Model -
Audit structure/plan
Differences between the current and MDSAP audit Model
Unannounced Audits
Witness audits
• Non-conformities grading under MDSAP
• Closing non-conformities with regulators in MDSAP
• Submitting reports to the regulators and their role in MDSAP
• Project plan for successful MDSAP completion
• Important timelines
• Case study
Why Should You Attend:
During this session we will cover:
• An excellent understanding of the MDSAP program
• Knowing how it might impact your company
• A clear understanding of your potential next steps
• Practical tips and guidance for actual implementation
Course Outline:
• What is MDSAP?
• Scope of MDSAP
• MDSAP a mandatory requirement for Canadian Market?
• MDSAP Audit Model
• Harmonization for quality systems compliance
• How to prepare for the MDSAP audit?
• Important timelines
• Case study
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
Anyone and everyone involved in ensuring regulatory compliance like VP, Director, Regulatory Affairs Manager, Quality Assurance Professional or Consultant. After attending this webinar you can make an informed decision about the MDSAP and how to prepare for it.
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
