2-day In-person Seminar: CAPA Systems for Medical Device Manufacturers
Dan O'Leary, President at Ombu Enterprises, LLC
Coming soon.. Please contact customer care for new schedule
||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).
- 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
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
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.
Register by P.O. / Check
Yes, I want to attend "2-day In-person Seminar: CAPA Systems for Medical Device Manufacturers".
Click here to download P.O. form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
Send your team for maximum benefit.
Get your team up to speed!
Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.
||Get 10% off
|3 to 6 Attendees
||Get 20% off
|7 to 10 Attendees
||Get 25% off
||Get 30% off
Call toll free on +1-888-717-2436 if you have any queries.
Register by Wire Transfer
If you wish to pay by wire transfer, please call us toll free on +1-888-717-2436
Terms & Conditions to register for the Seminar/Conference/Event
Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ firstname.lastname@example.org
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.
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
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.
Regulatory Affairs Certificate Program (By Regulatory Affairs Professionals Society RAPS)
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.
How to get RAPS certificate?
After completion of course "CAPA Systems for Medical Device Manufacturers" RAPS certificate will be issued to attendee.
If you wish to partner with us for this event
contact us: email@example.com
call us: 1-888-717-2436.
Media Partner Benefits
- Logo and company data on the event website.
- Logo on the conference material distributed during the conference.
- Media Partner’s brochure distributed along with conference material.
- Logo on all the mailings before and after the event.
- 10% discount to media partner's subscribers.
Media Partner to do
- Banner (min 728x90 or 468x60) on the Media Partner website.
- Insertion of the event in the event calendar, both printed and/or online.
- Announcement article of the conference on the Magazine and/or Website.
- Dedicated email blast to all subscribers of Media Partner.
- Article on the Magazine and/or Website after the conference.
If you wish to sponsor this event
contact Ben Hobbs: firstname.lastname@example.org
call us: (650) 620-2941
Boston Public Garden
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.
Boston Public Library
The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.
Museum of Fine Arts
Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.
Museum of Science
The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.
This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.
Old North Church
The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.