Course description
MDSAP and Regulatory Transitions - The Basics Virtual Training
This course has been reviewed for technical accuracy as of March 2019. All contents are validated to current requirements as of this date. Please note, some references such as transition dates have now passed since the making of this course. However, NSF continues to provide this offering, as the technical content remains accurate and a necessary tool for the medical device industry.
NSF International’s web-based virtual training course provides the basic knowledge to prepare for MDSAP, helps key personnel realize the urgency regarding MDSAP readiness and offers answers to vital questions direct from global Quality Systems expert, Kim Trautman, a former U.S. FDA official and key member of the original MDSAP development team. Kim also authored and led the implementation of the current U.S. FDA Quality System regulation and is a globally-recognized leader of continuing harmonization efforts for ISO 13485.
What You Get
- A 90 minute video presentation from MDSAP recognized expert, Kim Trautman
- Competency assessment certification to add to your company’s training files (2 hours, including exam)
Upcoming start dates
Outcome / Qualification etc.
Certificate
By completing/passing this course, you will attain the certificate Medical Device Certificate
Training Course Content
By the end of this course, you should:
- Understand the new regulatory audit findings/nonconformance grading system and know what grades trigger regulatory follow-up within MDSAP
- Learn the value of the MDSAP audit model
- Be familiar with the premise of the MDSAP audit time calculations
- Be familiar with the basic information to be included in the MDSAP audit report
- Understand the MDSAP timeline and other upcoming regulatory changes
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Expenses
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.