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    Webinar-Anticipation and Expectations of a Medical OEM Design Control Audit

    View: 117

    Website https://compliance2go.com/product/?pid=CP2014-361 | Want to Edit it Edit Freely

    Category Medical Device

    Deadline: October 15, 2014 | Date: October 15, 2014

    Venue/Country: Houston, U.S.A

    Updated: 2014-09-29 16:14:21 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    This webinar on a Design Control Audit by the FDA and other bodies will provide an understanding of what a medical OEM should anticipate during an audit during a design control audit. All medical device companies that are in need of examining their design control process should be aware of what to expect.

    Why Should You Attend?

    The FDA and other authorizing bodies have become more stringent in their examination of medical OEM procedures, process, and data. Many medical industry companies have not completed all their testing and design reviews before commercialising products properly or brought their mature product lines up to current FDA standards and are not in total compliance. This webinar shows the process to be followed for developing a standard procedure to identify what is expected for design control.

    For example, companies should be compliant to 21 CFR 820, ISO 13485:2003, ISO 14971:2007, etc. Design History Files and validations need to be up to date to meet current standards. The FDA and other authorising bodies expect continuous improvement and risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product and updated validations for product and processes. It should describe the risk acceptance criteria as well as roles and responsibilities of each member on the team.

    In this webinar, we will discuss practical steps you can follow to make sure your product design control and quality files are ready for an audit. It will also give the attendee guidelines on how to deal with the authorising bodies.

    Areas Covered in the Seminar:

    Champion/Multi-functional team approach/responsibility

    Dealing with the FDA and other authorizing bodies

    Phase by phase design process check list

    Design input/output

    Design verification/validation

    Design changes

    Design review

    Design History File (DHF)

    Due-diligence

    Gap analysis ? data gathering for the design history files

    Risk assessment

    Design changes

    Planning to be prepared

    Who will benefit:

    This webinar will provide valuable assistance and give a process to all medical device and regulated companies that need to prepare for an FDA or authorizing bodies audit in the future. The employees who will benefit include:

    End-users responsible for design control and technical files

    R&D and product development

    Process engineers and managers

    Operations and plant management

    Validation engineers

    Remediation teams

    QA, Regulatory Affairs

    QC and Corporate Auditors

    All team members who contribute to design history files, clinical, verifications/validations, risk management or technical files

    Consultants

    Project managers

    Supplier management

    Product transfer engineers

    All Contract Manufacturers working in the medical industry

    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.