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    FDA Regulations for Analytical Instrument Qualification and Validation Processes

    View: 114

    Website | Edit Freely

    Category Management, Production, Quality Management /Assurance, Regulatory

    Deadline: January 28, 2020 | Date: January 28, 2020

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

    Updated: 2020-01-04 15:28:26 (GMT+9)

    Call For Papers - CFP

    The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility?

    This 90 minute webinar will provide attendees the regulatory background and guidance through the complete process from planning and writing requirement specifications to vendor assessment, installation and operational qualification and ongoing testing during routine use. This webinar will help attendees understand the instrument qualification and system validation processes.

    Session Highlights:

    • Requirements and approaches for Analytical Instrument Qualification

    • Risk based validation approach

    • Going through the qualification phases

    • User requirements, writing the specifications

    • Testing and deviation handling

    • Proper documentation

    • Type and extend of qualification for USP Instrument Categories

    • Periodic review and revalidation analytical instruments and equipment

    • Wrap up - Final questions and answers

    Instructor Profile:

    Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing.

    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.