Course Description:

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

Implementing an effective system for corrective action and preventive action can be a major challenge. FDA illustrates the point in its published information on Warning Letters. FDA cited the CAPA subsystem in 81 of 89, 91%, of Warning Letters issued in 2010, the most recently available data. The CAPA subsystem includes nonconforming material, corrective and preventive action, and complaints (820.90, 820.100, 820.198). The trend continues in recent warning letters.

This interactive two-day course provides the tools you need to develop and implement an effective medical device CAPA system. In addition to FDA QSR, the course covers the corresponding requirements in ISO 13485 as well as the linkage to risk management in ISO 14971. Corrective action requirements extend beyond the basic QMS to include field actions, so the course includes adverse event reporting, Corrections & Removals, Field Safety Corrective Actions, and Field Safety Notices.

CAPA does not stand alone; it is most effective when it is an integral part of the Quality Management System and influences all of the other subsystems. The overarching objective of the course helps the participants develop the tools and methods. The course utilizes a broad variety of available material including FDA guidance documents, Global Harmonization Task Force (GHTF) guidance documents, ISO guidance documents, and European Union medical device guidance documents (MEDDEV).

Learning Objectives:

  • Develop the tools and methods to create an integrated CAPA system.
  • Explain the difference between correction, corrective action, and preventive action and understand why they are different.
  • Gain knowledge of the medical device CAPA regulatory requirements including FDA QSR and ISO 13485.
  • Evaluate common problem solving and improvement methodologies, explain the quality tools, and apply them to the CAPA system.
  • Understand “appropriate statistical methodology” to analyze data and identify existing and potential causes of quality problems.
  • Identify the linkages between complaints, corrective action, and risk management.
  • Understand the regulatory requirements for corrective actions in the field for both the US and the EU.

Who will Benefit:

While the course is specific for medical device companies, any company can benefit from an effective CAPA system. It is ideal for:

  • Quality Managers
  • Quality Engineers
  • Regulatory professionals
  • Operations Managers
  • Manufacturing Engineers
  • Risk Managers
  • Complaint system team members
  • CAPA team members

Course Outline:

Day One – The Regulatory Framework

Day Two – Tools for an Effective System

  • Understanding corrections, corrective action, and preventive action
  • Principles of FDA’s Quality System Regulation (QSR)
  • Principles of ISO 13485:2003
  • Contrasting QSR and ISO 13485
  • Requirements for the CAPA subsystems
  • Using the GHTF guidance document
  • Complaints and corrective action
  • FDA MDRs and EU Vigilance
  • FDA Corrections and Removals
  • EU Field Safety Corrective Action and Field Safety Notices
  • Understanding MEDDEV 2.12-1 Rev 7
  • What CAPA does
  • Using the FDA guidance documents
  • Metrics for a CAPA system
  • Metrics for the impact of CAPA on other subsystems
  • Investigation and problem solving methods as CA
  • Improvement methods as PA
  • Quality tools for CAPA
  • Interactive exercises using quality tools
  • Concepts of data analysis
  • Sources of quality data
  • Statistical tools for CAPA
  • Interactive exercises using statistical tools

Meet Your Instructor

Dan O'Leary
President at Ombu Enterprises, LLC

Dan O'Leary has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.

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With the simple approach take by Dan, anyone can learn how to complete a successful MDD implementation.
- Quality Specialist, Rochester Medica

Dan OLeary displayed complete and total Mastery of the subject in this presentation, and in his answers to the questions asked from him.
- Quality Manager, Parker Hannifin Corp

I enjoyed Dan's course very much. The Instructor and materials were excellent and the information he taught will be very helpful to my Company.
- Compliance Coordinator, Diagnostica Stago, Inc.

The MDD subject matter was well illustrated by Den by flow chart and graphics. Please keep offering this subject matter.
- Senior Quality Assurance Engineer, NDI Medical LLC

I have attended webinars from ComplianceOnline but this "Live" one was incredible. This seminar was excellent.
- Quality Engineering Manager, ConvaTec Inc.

I like the medical device directive and topic regarding standards. The design of the presentations was appropriate.
- Director of Research and Development, Metrex Research,LLC

It was well organized event by ComplianceOnline. Communication was good. Presenter was very knowledgeable. Practical application of directives, standards, regulations are very helpful.
- Manager, Quality Assurance, Instrumentation Laboratory

It was well organized event by ComplianceOnline with good subject matter and knowledgeable instructor.
- Director of Operations and Quality, NDI Medical LLC

I appreciate the knowledge given at this seminar. Speaker is very experienced and I found good talent here. I am very happy with first class reference sheet.
- Sr. CAPA Specialist, Johnson & Johnson Vision Care Inc

Knowledgeable speaker with great real life examples and discussions.
- Quality Director, Lifecore Biomedical

It was a well organized seminar. It provides trainees a good understanding about the CA-PA process that complies with regulatory standards.
- QA/RA Representative, ResMed Corp

It was my first conference with ComplianceOnline and experience was good. Love the reference material and flash key.
- Quality Assurance, Beckman Coulter

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