FEB 21, 2018 8:00 AM PST

WEBINAR: Automating Biopharma Quality Control to Reduce Costs and Improve Compliance

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: February 21, 2018
    TIME: 8:00AM PST, 11:00AM EST

    One report suggests that an average pharmaceutical manufacturing plant spends around €40M per year on quality control1. At the same time another report states that 79% of all 483 Warning Letters issued by the FDA in 2016 cited 21CFR part 11 data integrity issues2. Whilst re-training is a common response to an FDA 483 Warning Letter, this may be only part of the solution: was the problem simply that the worker(s) didn’t understand the SOP correctly, or was it really that the SOP is not robust enough to prevent future recurrences of the problem? Any process that automates the quality control SOP can potentially both reduce the impact of human error on data integrity issues and also bring welcome savings by reducing the time technicians need to devote to carrying out the SOP. This presentation takes a look at some common quality control procedures and how automation can help improve data integrity by reducing opportunities for human error, whilst at the same time potentially reducing operating costs.

    Learning Objectives:

    • Learn how automating quality control testing can reduce costs

    • Learn how 21CFR part 11 compliance can be improved by automating quality control testing

    • Learn how re-training is only part of a CAPA response to a regulatory inspection finding


    Show Resources
    You May Also Like
    NOV 18, 2020 8:00 AM PST
    C.E. CREDITS
    NOV 18, 2020 8:00 AM PST
    DATE: November 18, 2020 TIME: 08:00am PDT We develop and implement technologies to solve some of the major bottlenecks in biomedical research. In particular, we establish new imaging approac...
    OCT 29, 2020 6:00 AM PDT
    C.E. CREDITS
    OCT 29, 2020 6:00 AM PDT
    Date: October 29, 2020 Time: 6:00am (PDT), 9:00am (EDT), Chronic inflammation can occur as a result of a combination of genetic predispositions and environmental factors. Epigenetic modifica...
    NOV 16, 2020 8:00 AM PST
    C.E. CREDITS
    NOV 16, 2020 8:00 AM PST
    Date: November 16, 2020 Time: 8:00am (PST), 11:00am (EST) CRISPR screening has become the prime discovery tool in modern biomedical research and drug discovery. At the same time, most screen...
    SEP 10, 2020 9:00 AM PDT
    C.E. CREDITS
    SEP 10, 2020 9:00 AM PDT
    Date: September 10, 2020 Time: 9:00am (PDT), 12:00pm (EDT) Osmolality testing is relevant throughout the entire bioprocessing workflow. As customers look to refine mAb and gene therapy workf...
    APR 01, 2021 8:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    APR 01, 2021 8:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    Date: April 01, 2021 Time: 8:00am (PST), 11:00am (EST) Generating therapeutic antibodies is far more challenging than obtaining antibodies that merely recognize their targets. Engineering po...
    APR 08, 2021 11:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    APR 08, 2021 11:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    Date: April 8, 2021 Time: 11:00am (PDT), 3:00pm (EDT) Pneumonia is a deadly condition with clinical outcomes highly dependent on prompt and appropriate therapy. Diagnosis of pneumonia is cha...
    FEB 21, 2018 8:00 AM PST

    WEBINAR: Automating Biopharma Quality Control to Reduce Costs and Improve Compliance


    Specialty

    Biotechnology

    Laboratory Testing

    Immunology

    Cancer Research

    Clinical Chemistry

    Molecular Biology

    Cell Biology

    Cancer Diagnostics

    Clinical Diagnostics

    Microbiology

    Cell Culture

    Biochemistry

    Molecular Diagnostics

    Clinical Research

    Genetics

    Geography

    North America48%

    Europe31%

    Asia11%

    South America4%

    Africa4%

    Oceania1%

    Registration Source

    Website Visitors60%

    Email Promotions19%

    WAVE Newsletter Promotion16%

    Social Media Promotions3%

    Website Banners1%

    Client/Sponsor Promotions1%

    Job Title

    QC/QA13%

    Facility/Department Manager13%

    Student11%

    Medical Laboratory Technician9%

    Scientist8%

    Research Scientist8%

    Executive8%

    Lab Management6%

    Educator/Faculty5%

    Medical Doctor/Specialist3%

    Engineer3%

    Marketing/Sales2%

    Post Doc2%

    Consultant2%

    Clinical Laboratory Scientist2%

    Biologist2%

    Veterinarian1%

    Organization

    Clinical Laboratory11%

    Academic Institution9%

    Biotech Company9%

    Research Institute7%

    Hospital6%

    Life Science Company5%

    Pharmaceutical Company3%

    Medical Device Company2%

    Ambulatory Care2%

    Consultant2%

    Industrial Company2%

    Medical Center1%

    Distribution/sales1%

    Non-Profit Organization1%

    Other4%


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