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    Process Validation - overview of Why and How

    View: 319

    Website https://compliance2go.com/product/?pid=CP2014-418 | Want to Edit it Edit Freely

    Category Medical Device

    Deadline: March 17, 2015 | Date: March 17, 2015

    Venue/Country: Online, U.S.A

    Updated: 2015-02-27 17:34:53 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    In this presentation will cover the requirements for process validation from FDA cGMP and ISO 13485. It will also cover when process validation and revalidation are necessary or desirable. An outline of equipment qualification necessary for some equipment and equipment in some processes will be given. An overview of what is required for process validation will be covered. Guidelines will be provided for attendees as well as information about where to get additional information.

    Why you should attend:

    Do you need to understand the fundamentals of Process Validation? If so this presentation will cover the FDA and ISO requirements and give an overview of how to meet them. Process validation is a requirement but knowing when to validate or revalidate a process is essential. If you do not validate you risk enforcement actions such as fines or recalls, but too much validation is costly in both time and money. This presentation will cover the basics of this important topic for those who are new to quality or new to process validation.

    Areas Covered In the Seminar:

    What is Process Validation

    Why is Process Validation necessary

    Process Validation Guidelines

    How to determine if a process requires Validation

    What processes should be validated

    Process Validation Outline

    IQ ? Installation Qualification

    OQ ? Operational Qualification

    PQ ? Performance Qualification

    Process Monitoring

    Who will benefit:

    This webinar will provide valuable assistance to all personnel in:

    Quality Engineering

    Manufacturing engineers

    Internal auditing

    Compliance

    Others in Quality

    Quality Managers new to medical devices or process validation

    Operations/Manufacturing Managers new to medical devices or process validation

    Medical device consultants new to process validation

    Free documents

    Process Validation Decision Tree Chart

    Process Validation guidelines

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    Copy of PowerPoint slides (PDF print only)

    60 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.