Course Description

Course "Medical Device Quality Systems, CAPA and European Medical Device regulations" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Day 1 - ISO 13485:2003 (includes comparison to ISO 9001:2008), Thursday, May 3, 2012

ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. ISO 13485 is also a critical system to assist with compliance to Canadian Medical Device regulations, European Medical Device (MDD) and IVD Directives, Japanese PAL requirements, and many other international regulatory requirements. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA’s Quality System Requirements under 21CFR 820.

This seminar includes an overview of the ISO 13485 standard to understand the requirements as well as practical methods to implement a successful quality management system. This course will also include discussions comparing ISO 13485 to ISO 9001, FDA, and European requirements.

Day 2 - MDD 93/42/EEC and CAPA (includes FMEA, Risk Management & Warning Letters), Friday, May 4, 2012

Corrective and Preventive Action (CAPA) is a requirement under international standards such as ISO 13485:2003, ISO 9001:2008 and FDA under 21CFR 820.

This seminar will define and explain Corrective Action and Preventive Action requirements as found in ISO 13485 and FDA requirements. The course includes discussions on root cause analysis, quality system trending, corrective action effectiveness, and how CAPA is critical to be linked to other parts of the quality system including customer complaints, manufacturing nonconformities, customer feedback, supplier performance, etc. Lastly, this course will include the consequences of poor adherence to these principles.

Compliance with the Medical Device Directive 93/42/EEC is a requirement to market medical device in the European Union.

Who will Benefit

This seminar will benefit medical device companies interested in understanding and implementing a quality management system that is universally accepted by regulatory authorities.

Employees who will benefit include:

  • Quality & Regulatory Professionals
  • Quality System Auditors
  • Manufacturing & Design Engineers
  • Marketing Product Managers

Areas Covered

Thursday, May 3, 2012

Friday, May 4, 2012

  • Principles of ISO 13485:2003
  • ISO 9001 & ISO 13485 Differences
  • Risk Management & ISO 14971
  • FDA’s MDR’s & EU Vigilance
  • Design Control
  • Requirements
  • Correction vs. Correction Action
  • CAPA & Risk Management
  • Determining Root Cause
  • Corrective Action Effectiveness
  • Quality System Trending
  • Linking CAPA to other parts of the quality system including customer complaints, customer feedback, supplier performance, and manufacturing non-conformities.
  • MDD 93/42/EEC & Essential Requirements

Meet Your Instructor

John Chapman
Principal at Chapman Consulting LLC

John Chapman , has over 35 years medical device regulatory experience and over 15 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. RAB Accredited Lead Auditor Course Certificate 1996. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.

Joseph Azary
Director Regulatory and Quality at Sekisui American Diagnostica

Joseph Azary , more than 20 years in the healthcare/medical device industry experience in all phases of regulatory affairs and quality assurance. Expertise in FDA compliance, regulatory and quality related to the healthcare industry. Worked with a variety of medical devices and with over 180 companies on various projects. Specializes in FDA 510(k) submissions, auditing, training, quality system development, adverse event reporting, complaint handling, ISO 9001 / 13485 preparation, device listing, technical writing, mock FDA audits, recall coordination, and regulatory strategic planning.

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The RAPS Regulatory Affairs Certificate Program offers unique curricula to round out your regulatory knowledge and professional skills with a focus on medical devices and/or pharmaceuticals. Whether you are looking to gain a better understanding of the regulated health product industry or bolster your credibility and resume or curriculum vitae, the Regulatory Affairs Certificate Program is a valuable resource in your pursuit of professional advancement.

After completion of course "Medical Device Quality Systems, CAPA and European Medical Device regulations" RAPS certificate will be issued to attendee.

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