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Medical Device Auditing Course: ISO 19011:2011 Framework

  January 24, 2018  
CfPIE - The Center for Professional Innovation & Education, Malvern, PA USA
November 5 - 7, 2018

Medical Device Auditing Training Course

Course Description – Course runs 9:00 to 5:00 on the first and second day; 9:00 - 12:00 p.m. on the third day

This medical device course covers current auditing compliance requirements with respect to managing a medical device quality system. This course is continually updated to stay current with modern compliance requirements.

Among the topics to be discussed are: ISO 19011, Types of Audits, Methods used in Audits, the Audit Process, Audit Follow-up, and Changes in Auditing based on Industry Dynamics, among others.

Who Should Attend?

Personnel involved in quality assurance, compliance or regulatory affairs who do not have an in-depth knowledge of the audit process and planning will benefit from this course. Additionally, this program can be customized and delivered on-site for more-experienced personnel (including middle and upper management) to update and broaden their knowledge of the audit process.This 2.5-day course will be most valuable to medical device quality assurance professionals involved in the evaluation of compliance of their quality systems and independent auditors needing an understanding of the types of auditing and auditing process. The course provides context for meeting the auditing requirements of ISO 19011:2011 with specific focus on the applicability to the transition to ISO 13485:2016.

Organized by: Center for Professional Innovation & Education
Invited Speakers:

Jim Rosa

Specialties: Medical Devices, Regulatory

Jim Rosa provides quality engineering guidance to companies for the development, management and operation of quality systems for devices.  He has 40 years of experience leading R&D and quality functions within regulated industries.  With roots in research and development and conversion to quality systems oversight later in his career, Jim provides a solid understanding and perspective from engineering and quality in bringing products to market in the medical device and IVD industries.  The blend of working with research & development and quality system function, in the EU and US, in startups and large companies provides a unique insight into the practical application of design control for medical devices.  Jim also has four patents related to medical device safety system implementations.  Jim has worked for Gambro, Intel, Reglera, Dohmen and a number of start-ups such as CeMines (IVD) and FibroTx(IVD).

Jim’s recent focus has been on Systems & Software within the medical device market, driving strategy and implementation efforts for traditional electromechanical, mobile applications, wireless applications, infrastructure software devices, and software as a device.  Additionally, Jim has taught Design Controls, V&V, and Risk Management at the University level.

Mr. Rosa has earned degrees from Colorado State University (MBA) and the Radford University (BSCS).

Other Courses:

Deadline for Abstracts: N/A
Registration: https://www.cfpie.com/ProductDetails.aspx?ProductID=304
E-mail: info@cfpie.com
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