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Course Description: This ​five-day ​course ​provides ​the ​skills ​and ​knowledge ​that ​have ​taken ​many ​experienced ​auditors ​decades ​to ​develop. ​During ​the ​course, ​you ​will ​plan ​and ​prepare ​audits ​based ​upon ​case ​studies ​that ​simulate ​both ​supplier ​and ​third-party ​audits ​utilizing ​the ​MDSAP ​audit ​requirements. ​Throughout ​the ​course, ​you ​will ​participate ​in ​simulated ​auditing ​exercises ​that ​include ​planning, ​preparation ​and ​evaluation ​of ​audit ​evidence. ​You ​will ​also ​practice ​the ​application ​of ​ISO ​13485:2016 ​and ​the ​MDSAP ​requirements. ​ Course Location: DoubleTree by Hilton Hotel London - Docklands Riverside- 265A Rotherhithe St, Rotherhithe, London SE16 5HW, United Kingdom Dates: Monday, May 11th to Friday, May 15th The 5-day event consists of 4 days of different interactive sessions about auditing followed by a 2-hour written examination on the 5th day.  Our course requires that you work together with your tutors for 40 hours before the examination. That means you will have four long 10-hour days together. After the 9:00am start on the first day, you will start at 8:30am on the next three days and will not finish until about 6:30pm every day (except for Friday where you will done around noon.)  To help us understand your needs and focus, there are two mandatory documents that are available once full payment is received. These will need to be completed and returned to (nwright@nsf.org) by the date indicated upon download.   Read More

  This course includes six modules, the first five modules cover the U.S. Quality Systems Regulation (21 CFR 820) and the sixth module covers the Combination Products Regulation (21 CFR Part 4.) Each module includes an approximately one-hour video instructional presentation by Kimberly Trautman, Executive Vice President, Medical Device International Services at NSF International, followed by an assessment on the information covered in the video. Kimberly Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. She led international initiatives for the U.S. FDA including conceiving, developing and launching the international Medical Device Single Audit Program. She wrote the current U.S. FDA Medical Device Quality System (QS) regulation, 21 CFR 820, and led the implementation associated with the QS regulation. She also led the harmonization efforts for ISO 13485 since its inception in 1994, serving as international delegate to ISO/TC 210 and the U.S. Technical Advisory Group co-chair for ISO/TC 210. Read More

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