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    Verification vs Validation-Product, Equipment and QMS Software

    View: 142

    Website http://www.compliance4all.com/control/w_product/~product_id=502001LIVE?channel=ourglocal_Aug_2018_SE | Want to Edit it Edit Freely

    Category QMS Software, Validation-Product, software quality assurance, iso 9001 software, quality system software, best quality management software, Compliance Solutions

    Deadline: August 13, 2018 | Date: August 15, 2018

    Venue/Country: Online, U.S.A

    Updated: 2018-06-07 14:33:24 (GMT+9)

    Call For Papers - CFP

    Overview:

    You will learn What do the U.S. FDA and EU Expect for Verification

    and Validation, Actions and documentation to meet U.S. FDA

    CGMP, ICH Q-series, and ISO 13485 expectations and

    requirements, ISO 14971 and IEC 62366 considerations, as

    appropriate.

    Why should you Attend:

    The FDA / ICH Q-series provide valuable insights for all regulated

    industries, not just pharma. Why "working definitions"? What's a

    field proven approach. Requirements to qualifications to test cases

    to the validation.

    Areas Covered in the Session:

    Verification or Validation Recent regulatory expectations

    The Validation Master Plan and its structure

    Product Validation - how it differs from process / equipment V&V

    Process / Equipment / Facility Validation including

    FDA's recent guidance

    Who Will Benefit:

    Senior management in Drugs, Devices, Biologics, Dietary

    Supplements

    QA

    RA

    R&D

    Engineering

    Production

    Operations

    Speaker Profile:

    John E. Lincoln is a medical device and regulatory affairs

    consultant. He has helped companies to implement or modify their

    GMP systems and procedures, product risk management, U.S. FDA

    responses. In addition, he has successfully designed, written and

    run all types of process, equipment and software

    qualifications/validations, which have passed FDA audit or

    submission scrutiny, and described in peer-reviewed technical

    articles, and workshops, world wide.

    Event Fee: One Dial-in One Attendee Price: US $290.00

    Contact Detail:

    Compliance4All DBA NetZealous,

    Phone: +1-800-447-9407

    Email: supportatcompliance4All.com


    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.