ComplianceOnline Announces Seminar on CAPA Systems for Medical Device Manufacturers

Top Quote ComplianceOnline, the leading GRC advisory network, and renowned regulatory affairs expert Dan O'Leary will conduct a two day seminar on CAPA Systems for Medical Device Manufacturers. End Quote
  • (1888PressRelease) November 13, 2012 - Palo Alto, CA, USA - ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced a seminar on CAPA Systems for Medical Device Manufacturers. The two day long seminar by respected regulatory affairs expert Dan O'Leary will be held on December 6 and 7, 2012 in Boston, MA.

    The lack of a proper CAPA system is one of the most cited violations in FDA Form 483s and Warning Letters issued to medical device manufacturers. This interactive two-day course provides the tools needed to develop and implement an effective medical device CAPA system.

    For more information or to register for the seminar, please click here.

    Seminar instructor 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. His professional experience relates to quality, regulatory, reliability, and operations management. Mr. O'Leary is a regular speaker at international conferences including ASQ, ISM, and RAMS. He teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management.

    During the two day interactive seminar, Mr. O'Leary will focus on how to develop the tools and methods to create an integrated CAPA system. He will discuss how to conceptualize and implement medical device corrective action and preventive action once faults have been found and analyzed. He will also explain how to evaluate common problem solving and improvement methodologies, the quality tools, and apply them to the CAPA system. He will also explain how to understand the regulatory requirements for corrective actions in the field for both the US and the EU.

    In addition to FDA QSR, the course covers ISO 13485 requirements as well as the linkage to risk management in ISO 14971. Corrective action requirements extend beyond the basic Quality Management System (QMS) to include field actions, so the course includes adverse event reporting, corrections & removals, field safety corrective actions, and field safety notices. The course will utilize a broad variety of available material including FDA guidance documents, Global Harmonization Task Force (GHTF) guidance documents, ISO guidance documents, and European Union (EU) medical device guidance documents (MEDDEV).

    The seminar will be valuable for quality managers, quality engineers, regulatory professionals, risk managers, CAPA team members, operations managers and manufacturing engineers. While the course is specific for medical device companies, any company can benefit from an effective CAPA system.

    Date: Thursday, December 06 and Friday, December 07, 2012, 9AM- 5 PM EDT
    Venue & Location: Boston Marriott Copley Place
    Boston, MA
    Registration Cost: $1,499.00 per registration
    Early bird discounts: For discounts on early registrations, please click here.
    Register by phone: Please call our customer service specialists at +1-650-620-3937 or email to customercare ( @ ) complianceonline dot com

    For more information on ComplianceOnline or to browse through our trainings, please visit our website

    About ComplianceOnline
    ComplianceOnline is a leading provider of regulatory/compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 20,000 professionals from 3,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at

    For more information please contact:
    A Reuben Bernard
    Manager of Program Marketing
    2600 E Bayshore Rd
    Palo Alto CA USA 94303
    650-620-3937 phone
    650-963-2530 fax
    reuben ( @ ) complianceonline dot com

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