BEGIN:VCALENDAR PRODID:NingEventWidget-v1 VERSION:2.0 METHOD:PUBLISH BEGIN:VTIMEZONE TZID:America/New_York X-LIC-LOCATION:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:19700308T020000 RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:19701101T020000 RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU END:STANDARD END:VTIMEZONE BEGIN:VEVENT UID:2140535:Event:69903 DTSTAMP:20260520T161844Z SUMMARY:Seminar on Effective and Efficient Internal and Supplier Quali ty System Auditing for Medical Devices at St Paul, MN DESCRIPTION:Course \"Effective and Efficient Internal and Supplier Qu ality System Auditing for Medical Devices\" has been pre-approved by  RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.\n \nOverview:\n \nDo you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but a lso add value to your company? Are you confused by all the requirement s and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they cont ain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This cours e will provide you with an easy to understand presentation on the audi ting process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP)\nBoth FDA Quali ty System Regulation (QSR) and ISO 13485 require that companies do int ernal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effec tiveness of their internal audit system from the FDA during FDA Inspec tions. ISO 13485 auditors do look at internal audits, but are most con cerned that you define a process that meets the requirements of the st andard and are following your process. Both require that you define Au ditor training is required, but this sometimes just requires reading t he company's procedure, although most external auditors will look for more than this.\nDo you need to train new auditors for yours medical d evice quality management system or to audit your suppliers? Or do you need to improve the training of your internal and supplier auditors so that they add value to these audits? If you need to do either of thes e, this seminar will provide this training. In addition to auditing sk ills and hands-on auditing exercises, this seminar will provide an ove rview of the requirements for Quality Management Systems (QMS) for bot h the FDA\n\nLocation: St Paul, Minnesota Date: June 16th & 17th, 201 6 and Time: 9:00 AM to 6:00 PM\n \nVenue: WILL BE ANNOUNCED SOON, St Paul, MN\n \nPrice Details:\n \n(Seminar Fee for One Delegate)-Price : $1,295.00  \nUntil May 15, Early Bird Price: $1,295.00 From May 16 to June 14, Regular Price: $1,495.00\n \nQuick Contact:\n \nNetZeal ous DBA as MentorHealth\nPhone: 1-800-385-1607\nEmail: support@mentorh ealth.com\nWebsite: http://www.mentorhealth.com/\nRegistration Link - http://www.mentorhealth.com/control/globalseminars/~product_id=200073S EMINAR\n \nFollows us:\n \nTwitter: https://twitter.com/MentorHealth 1\nLinkedIn: https://www.linkedin.com/company/mentorhealth\n \n \n  \n \n\nFor more information visit https://medtechiq.ning.com/events/s eminar-on-effective-and-efficient-internal-and-supplier-quality DTSTART;TZID=America/New_York:20160616T090000 DTEND;TZID=America/New_York:20160617T180000 CATEGORIES:seminar LOCATION:St Paul, MN WEBSITE:http://www.mentorhealth.com/control/globalseminars/~product_id =200073SEMINAR URL:http://www.mentorhealth.com/control/globalseminars/~product_id=200 073SEMINAR CONTACT:8003851607 ORGANIZER:Netzealous -MentorHealth ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562013960?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Roger St even":https://medtechiq.ning.com/profile/RogerSteven END:VEVENT END:VCALENDAR