• NCBioNetwork Fundamentals of Validation

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    Name: NCBioNetwork Fundamentals of Validation
    Date: April 12, 2019
    Time: 8:00 AM - 5:00 PM EDT
    Event Description:

    This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical product validation. A brief historical overview of regulatory requirements is followed by current requirements, user needs, process design and control, qualification, process validation, and cleaning validation activities. Hands-on activities are utlized to enhance understanding.

    Topics Include

    • Factors precipitating FDA’s validation concept and approach.
    • Design, installation, operational, and performance qualification.
    • Foundational concepts and approaches established by FDA’s 1987 “Guideline on General Principles of Process Validation.”
    • The “Design Control” approach to medical device validation.
    • The influence and impact of CGMPs on validation
    • Validation principles updated by the 2011 FDA Guidance to Industry “Process Validation: General Principles and Practices.”
    • The regulatory basis for drug and medical device validation requirements.

    Learning Objectives

    • Gain an understanding of the motivation and purpose of medical product validation.
    • Differentiate between the qualification and validation practices.
    • Be orientated to requirements of the 2011 FDA Guidance to Industry "Process Validation: General Principles and Practices" and EudraLex Vol. 4 Annex 15 "Qualification and Validation."

    Audience

    • Technicians in pharmaceutical manufacturing.
    • Quality control personnel.
    • Engineering/maintenance personnel.
    • Quality assurance and regulatory affairs.
    Location:
    BTEC, Room 120
    850 Oval Drive

    Raleigh, NC 27695

     
    Date/Time Information:
    April 12
    8:00 a.m. - 5:00 p.m.
    Fees/Admission:
    Register here, $150
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