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    HEALTHCARE 2020 - 6-Hour Virtual Seminar on Medical Device Single Audit Program

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    Website https://www.globalcompliancepanel.com/virtual-seminar/-10423LIVE?channel=ourglocal-May_2020_SEO | Want to Edit it Edit Freely

    Category HEALTHCARE 2020

    Deadline: May 13, 2020 | Date: May 13, 2020

    Venue/Country: Online Event, U.S.A

    Updated: 2020-03-13 21:17:49 (GMT+9)

    Call For Papers - CFP

    Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable.

    One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan. Health Canada has now made the MDSAP process mandatory for all licensed products in Canada.

    Why you should attend

    This 6 hrs. webinar is focused on understanding the Medical Device Single Audit Program, the scope of the program, how to apply, the Authorized Organizations, the rating system developed and what you can expect when signing onto the program. The webinar will discuss how such audits are organized, what to expect during a MDSAP audit, how does this differ from a typical certified body audit, along with document movement and timeline expectations in receiving the facility’s certificate.

    Highlights of the key Regulatory Requirements for Medical Devices will also be covered for the participating MDSAP Countries of: U.S., Canada, Brazil, Australia and Japan.

    Learning Objectives:

    The Medical Device Single Audit Program (MDSAP)

    Device Classification

    Licensing Pathways

    Medical Device GMP

    Inspections

    Device Labeling

    License Holder Responsibilities

    Timelines and Fees

    Country Specific Cultural Considerations and Challenges

    Adverse Event Reporting

    Who Will Benefit

    Regulatory Affairs

    Quality Assurance, Quality control, and Quality systems

    Product Development Personnel

    Contract Research Organizations

    Business Management

    Site Managers

    Senior and Executive Management

    Contractors and Subcontractors

    Distributors

    Consultants

    https://www.globalcompliancepanel.com/virtual-seminar/-10423LIVE?channel=ourglocal-May_2020_SEO


    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.