Course Description:
The FDA’s Quality System Regulation (QSR) is the required Quality Management System (QMS) for device manufacturers who market their products in the US, regardless of the manufacturing location in the world.
Understanding the QSR is important for device manufacturers to build an effective and compliant system. The workshop takes you through the regulatory requirements and explains how to implement them. The workshop provides guidance on the regulatory requirements and explains how they support the safe and effective manufacture of medical devices.
In addition, the workshop explains the history of QSR and its relationship to ISO 9001. The workshop explains how FDA Inspectors evaluate an implementation using the FDA’s Quality System Inspection Technique (QSIT). The workshop uses FDA Warning Letters to illustrate the kinds of problems FDA Inspectors uncover.
Areas Covered:
The workshop covers the following areas:
- Laws and regulations in the US
- Medical device risk classes in the US system
- The management structure
- Management responsibility
- Internal quality audits
- Documents and records
- Employee competence
- Design control
- Design inputs
- Design verification and validation
- Design reviews
- Production and process controls
- Automated processes
- Process validation
- Inspection, test, and measuring equipment
- Purchasing
- Acceptance activities
- Corrective Action and Preventive Action
- Implementing corrective action
- Complaint management
- Medical device reporting
- Correction and removals
Who will Benefit:
This seminar is valuable to anybody involved in medical device manufacturing for the US market. The employees who will benefit include:
- Research and development
- Production
- Regulatory affairs
- Quality assurance
- Quality control
- Senior and executive management
Course Outline:
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Meet Your Instructor
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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. |
Register Now
Online using Credit card
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Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.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 @ [email protected]
Payment:
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 $100 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 ($100) 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.
Testimonials
What past attendees say:
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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