Seminar on Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices at St Paul, MN

Course "Effective and Efficient Internal and Supplier Quality 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.

Overview:

Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP)

Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections. ISO 13485 auditors do look at internal audits, but are most concerned that you define a process that meets the requirements of the standard and are following your process. Both require that you define Auditor training is required, but this sometimes just requires reading the company's procedure, although most external auditors will look for more than this.

Do you need to train new auditors for yours medical device 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 these, this seminar will provide this training. In addition to auditing skills and hands-on auditing exercises, this seminar will provide an overview of the requirements for Quality Management Systems (QMS) for both the FDA

Location: St Paul, Minnesota Date: June 16th & 17th, 2016 and Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON, St Paul, MN

Price Details:

(Seminar Fee for One Delegate)-Price: $1,295.00  

Until May 15, Early Bird Price: $1,295.00 From May 16 to June 14, Regular Price: $1,495.00

Quick Contact:

NetZealous DBA as MentorHealth

Phone: 1-800-385-1607

Email: support@mentorhealth.com

Website: http://www.mentorhealth.com/

Registration Link - http://www.mentorhealth.com/control/globalseminars/~product_id=200073SEMINAR

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