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    Medical Device Quality and Regulatory Compliance Concepts- Part 1

    View: 340

    Website 0777WestheimerSuite1100,Houston,Texas,USA | Want to Edit it Edit Freely

    Category Houston

    Deadline: July 28, 2016 | Date: July 28, 2016

    Venue/Country: Online, U.S.A

    Updated: 2016-07-02 18:02:49 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    This 3-hr webinar (split into two 90-minute sessions- Parts 1 and 2) will help you understand the basics of medical device quality and regulatory compliance concepts. You will also learn the purpose and scope of medical device laws, regulations, directives, standards, and guidance, the types of medical devices, quality and administrative requirements, the similarities and differences between FDA and Notified Body medical device requirements, and what is expected before, during, and after an external auditing body examines your quality system procedures and documentation.

    Why should you attend :

    Most industry personnel are overwhelmed by national and international quality system laws, directives, regulations, standards, and guidance documents. As such, they believe if they obtain quality system certification from a European Notified Body that they will automatically pass an FDA audit. However, this is not the case, especially in the quality system areas of management controls, design controls, CAPA system, and production and process controls. FDA warning letter after Warning Letter prove otherwise…True that Europe’s quality management system standard (ISO 13485) and U.S.A’s quality system regulation (21 CFR Part 820) are very similar in nature; however, your quality system is viewed totally different by the FDA than by the European Union. Not only is it required under law to have quality system procedures and records, however the FDA requires you to also have a sound quality system with linkages to other medical device laws and regulations (such as pertaining to medical device registration and listing, market submissions, adverse events, and corrections and removals); whereas the Notified Bodies do not. If top management do not initiate an effective quality system, not only may regulatory compliance sanctions against the company occur, but the company may also loose its competitive advantage, have customer lawsuits, perform unnecessary recalls, and be known as a company with non-quality products and services. Additionally, just because the FDA investigator is not allowed to address certain administrative violations (such as pertaining to registration and listing, or market submissions) in FDA 483s (Objectionable Findings List), it does not mean that the compliance officer, who issues Warning Letters and other enforcement actions, will not address these findings. By understanding medical device quality and regulatory compliance concepts, you can prevent or minimize FDA enforcement actions.

    Areas Covered in the Session:

    This 1 part webinar will provide valuable assistance to all medical device companies in developing a sound quality system, The focus will be a basic understanding of medical device quality and regulatory compliance without confusing everyone with regulatory compliance jargon. The webinar will include the following:

    1) Basic quality concepts;

    2) The differences between quality control, quality assurance, and GMPs; and

    3) Quality system concepts;

    Who will benefit: (Titles)

    The employees who will benefit most include:

    Senior management,

    Regulatory Affairs, Regulatory Compliance, Quality Assurance, and Quality Control personnel,

    Quality, Manufacturing, and Design engineers,

    Sales and Marketing, Maintenance, and Operational personnel, and

    Anyone else who manages, assesses, or performs any medical device quality work.

    However, if you are already familiar with the basic medical device quality and regulatory compliance, you may recommend this webinar to anyone in your company that has questions about the medical device compliance.

    Webinar includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    90 Minutes Live Presentation

    Certificate of attendance


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.