MENU
JUL 19, 2017 7:00 AM PDT

Data Integrity and the FDA Guidance

Speaker
  • Senior Marketing Manager, Beckman Coulter
    Biography
      Tony held the Convenorship of the ISO Working Group revising ISO 14698-1 & -2 for microbial control in cleanrooms and was the UK subject matter expert to the ISO Working Group who issued the 2015 revised versions of the ISO 14644-1 & -2 documents for cleanroom classification at the heart of the aseptic manufacturing chapters of both the European GMP and the USA cGMP documents. Tony was joint editor on the ISPE Guide to Ozone Sanitization of Pharmaceutical Water Systems and was also chief editor of the PHSS Best Practice Guide for Cleanroom Monitoring. Tony is employed by Beckman Coulter Life Sciences as a Senior Manager.

    Abstract

    DATE: July 19, 2017
    TIME: 7:00am PT, 10:00am ET, 4:00pm CET

    According to a recent report, 79% of FDA 483 Warning Letters issued in 2016 cited data integrity. In their guidance on data integrity and compliance with CGMP, the FDA issued their ALCOA definition of data integrity. This seminar will discuss ALCOA using cleanroom environmental monitoring data collection in the pharmaceutical industry as an example.


    Show Resources
    You May Also Like
    MAY 11, 2021 10:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    MAY 11, 2021 10:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    Date: May 11, 2021 Time: 10:00zm PDT Your samples are some of the most valuable assets in the laboratory. After spending countless hours on extraction and preparation, your conclusions could...
    DEC 02, 2020 8:00 AM PST
    C.E. CREDITS
    DEC 02, 2020 8:00 AM PST
    DATE: December 2nd, 2020 TIME: 08:00am PDT, 11:00pm EDT Bioreactors and shakers are used to cultivate microorganisms, plant, insect, and mammalian cells in different volumes. Upscaling of pr...
    APR 21, 2021 10:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    APR 21, 2021 10:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    Date: April 21, 2021 Time: 10:00am (PDT), 1:00pm (EDT) Serological testing for SARS-CoV-2 has been steadily adopted into clinical practice over the course of this pandemic. In this webinar,...
    JUN 09, 2021 7:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    JUN 09, 2021 7:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    Date: June 9, 2021 Time: 09 June 2021, 7am PDT, 10am EDT, 4pm CEST cells with dramatic implications on the validity of past cell culture related research. The fact that at least 509 cell lin...
    JAN 21, 2021 8:00 AM PST
    JAN 21, 2021 8:00 AM PST
    Date: January 21, 2021 Time: 8:00am (PST), 11:00am (EST) Today, critical reagent characterization is a key component in the overall workflow to establish robust ligand binding assays (e.g.,...
    DEC 16, 2020 8:00 AM PST
    C.E. CREDITS
    DEC 16, 2020 8:00 AM PST
    Date: December 16, 2020 Time: 8:00am (PST), 11:00am (EST) Molecular imaging of living specimens offers a means to draw upon the growing body of high-throughput molecular data to better under...
    JUL 19, 2017 7:00 AM PDT

    Data Integrity and the FDA Guidance


    Specialty

    Biotechnology

    Laboratory Testing

    Molecular Biology

    Clinical Diagnostics

    Immunology

    Cancer Research

    Infectious Disease

    Clinical Research

    Molecular Diagnostics

    Microbiology

    Genetics

    Biomarkers

    Drug Discovery

    Cell Biology

    Clinical Chemistry

    Geography

    North America55%

    Europe24%

    Asia11%

    South America3%

    Africa1%

    Registration Source

    Website Visitors100%

    Job Title

    Scientist15%

    Executive14%

    Facility/Department Manager12%

    QC/QA11%

    Research Scientist8%

    Lab Management6%

    Medical Laboratory Technician6%

    Medical Doctor/Specialist4%

    Educator/Faculty4%

    Consultant3%

    Clinical Laboratory Scientist3%

    Chemist3%

    Marketing/Sales3%

    Post Doc2%

    Student2%

    Engineer2%

    Microbiologist2%

    Organization

    Biotech Company8%

    Clinical Laboratory6%

    Academic Institution5%

    Pharmaceutical Company5%

    Hospital4%

    Research Institute3%

    Contract Research Organization (Cro)2%

    Life Science Company2%

    Government2%

    Industrial Company2%

    Medical Device Company2%

    Consultant2%

    Medical School2%

    Ambulatory Care1%

    Other4%


    Show Resources
    Loading Comments...
    Show Resources
    Attendees
    • See more