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An Interactive Workshop on Auditing and FDA Quality Management System (QMS) For Medical Devices Including In Vitro Diagnostic Medical Devices | Day 3

By:
David Lim, Ph.D., RAC, ASQ-CAQ
Coming soon.. Please contact customer care for new schedule

Course Description:

Course "An Interactive Workshop on Auditing and FDA Quality Management System (QMS) For Medical Devices Including In Vitro Diagnostic Medical Devices" has been pre-approved by RAPS as eligible for up to 6 credits towards a participant's RAC recertification upon full completion.

At this workshop, Dr. David Lim will walk you through to get familiar with the following subject areas.

Auditing and FDA Quality Management System for Medical Devices Including In Vitro Diagnostic Medical Devices

This workshop is intended to provide guidance on establishing and following auditing and quality management system for medical devices including in vitro diagnostic devices.

During this workshop (November 2, 2012), we will discuss how to establish and follow auditing and FDA compliant quality management system for medical devices including in vitro diagnostic devices.


Why Should You Attend:

Developing, implementing and following auditing and FDA-compliant QMS can significantly improve various processes in an organization and further expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.

At this workshop, you will get familiar with auditing and QMS pertaining to medical devices, active implantable medical devices and in vitro diagnostic medical devices.


The following key areas will be discussed during workshop:

  • Auditing
  • FDA Quality Management System
  • ISO 14155
  • ISO 14971
  • Various FDA, GHTF and MEDDEV Guidance Documents



Who will Benefit:

This seminar will be valuable for anyone in the FDA-regulated industry, including, but not limited to, medical devices, active implantable medical devices, in vitro diagnostic medical devices or combination products. This seminar will be particularly useful for those who are involved in quality, clinical and regulatory affairs and compliance.

This workshop is a must for those directly or indirectly involved in quality, clinical and regulatory affairs and compliance. In addition, this workshop will also be very beneficial to those preparing for and handling conformity assessment applications for CE marking purposes.

The following employees who will benefit include:

  • Regulatory affairs (associates, specialists, managers, and directors)
  • Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
  • Research and development (associates, scientists, managers, directors and VPs)
  • Product and development (associates, scientists, managers, directors and VPs)
  • Contract research organization (associates, scientists, managers, directors and VPs)
  • Site managers, and consultants
  • Senior and executive management (VPs, SVPs, Presidents and CEOs)
  • Contractors and subcontractors
  • Anyone interested!



Course Outline:

Schedule for Day 3, 9:00 AM - 4:00 PM | (Audit & QMS)
Morning  
9:00 AM - 10:30 AM
[Audit(ing)]
  • Auditing
  • Definitions, principles and procedures
  • Defining, documenting and implementing audit(ing)
  • Maintaining and improving audit(ing)
10:30 AM - 10:40 AM Short Break
10:40 AM - 12:00 Noon
[Quality Management System; QMS]
  • FDA Quality management system
  • ISO 14971
  • ISO 14155
  • FDA guidance documents including GHTF and MEDDEV documents
12:00 Noon - 1:00 PM Lunch
Afternoon  
1:00 PM - 2:30 PM
[Quality Management System; QMS]
  • Quality manual
  • Quality requirements, procedures, and processes
2:30 PM - 2:40 PM Short Break
2:40 PM - 4:00 PM
[Quality Management System; QMS]
  • Defining, documenting and implementing QMS
  • Maintaining and improving QMS
  • Lessons learned



Meet Your Instructor

Dr. David Lim
Ph.D., RAC, ASQ-CAQ

Dr. David Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com/davidlim), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Currently, Dr. Lim is serving as a faculty at the Regulatory Affairs Professional Society (RAPS) and is an advisor to the Presidents and CEOs of FDA-regulated industry.




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Bring this seminar to your organization;
Call +1-650-284-1699 for more details.
or email to p.shetty@complianceonline.com

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Yes, I want to attend "An Interactive Workshop on Auditing and FDA Quality Management System (QMS) For Medical Devices Including In Vitro Diagnostic Medical Devices | Day 3".

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Suite 200
Palo Alto, CA 94303
USA

Group Registrations

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.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

Register by Wire Transfer




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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 @ editor@complianceonline.com

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.

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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.

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Testimonials

I think the material and instructor were very knowledgeable and material was excellent. The subject was well chosen and the design of presentation was most appropriate.
- QC, Regulatory affair

My colleague referred me to this event and It was good value for the price. Excellent friendly presenter and coordinator. The amount of interaction between the participants and presenters was ideal. I would also like to recommend this seminar to others.
- Regulatory Manager

I think the instructor were very knowledgeable and material was excellent. Example and templates of PMA & 510k submissions were very useful because it set the framework of how to submit a quality 510k.
- Regulatory Manager

I had very focused reason to attend this seminar: learning more about 510k, classes and requirements. The program was well organized and coordinated by ComplianceOnline.
- Quality Analyst

Dr. Lim is very knowledgeable. The amount of interaction between the participant and presenter was ideal. I would like to refer his trainings to my colleagues.
- QC, Regulatory Affairs

All the topics were well chosen and the design of the presentation was most appropriate. I like the topic “Template for Submission” most. David Lim is an excellent friendly presenter. Overall it was good value for the price with ComplianceOnline.
- Managing Director

ComplianceOnline Seminar offered a lot of valuable and relevant information. Thanks for organizing it very well and professionally. I would like to attend next seminar with in depth classification of medical device.
- Manufacturing Engineer

Speaker was great. The event was well organized and coordinated by ComplianceOnline. I would recommend this to others. Thanks!
- Attorney (Patent)





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  • 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.

 



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