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 holds a Bachelor's Degree in Electrical & Electronic Engineering and is employed by Beckman Coulter Life Sciences as a Senior Marketing Manager.

      Experienced in water system TOC, conductivity and ozone analysis and cleanroom environmental monitoring as well as particle characterisation, Tony has spent the last fifteen years in applied metrology for the pharmaceutical and healthcare manufacturing industries. Prior to that, he worked for companies providing process control automation solutions for manufacturing industries.

      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 a well-known international speaker and has provided educational seminars on TOC, liquid particle counting, ozone sanitization for water systems and cleanroom monitoring in UK, France, Italy, India, Malaysia, China, USA, Scandinavia, Ireland, Hungary, Switzerland, Indonesia, Belgium, Greece, Switzerland, Turkey, Egypt, Denmark, Poland, Italy and most recently South Africa and Columbia.

    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
    APR 07, 2020 8:00 AM PDT
    C.E. CREDITS
    APR 07, 2020 8:00 AM PDT
    DATE: April 7, 2020 TIME: 8:00am PT, 11:00am ET This webinar sets out to establish why quality control is key to robust, reliable, reproducible science. We will look at best practice criteri...
    JAN 23, 2020 9:00 AM PST
    C.E. CREDITS
    JAN 23, 2020 9:00 AM PST
    DATE: January 23, 2020 TIME: 9:00am PST, 12:00pm EST...
    JUN 30, 2020 9:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    JUN 30, 2020 9:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    DATE: June 30, 2020 TIME: 9:00am PDT, 12:00pm EDT QC laboratories perform a critical role in demonstrating pharmaceutical products are consistently manufactured, safe, potent, and pure. At t...
    MAY 12, 2020 9:00 AM PDT
    C.E. CREDITS
    MAY 12, 2020 9:00 AM PDT
    NEW DATE: Date: May 12, 2020 Time: 9:00am PDT, 12:00pm EDT...
    JUN 09, 2020 10:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    JUN 09, 2020 10:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    DATE: June 9, 2020 TIME: 10:00am PT, 1:00pm ET The presentation will first discuss sepsis as a disease and then explain the importance of performing diagnostic tests in the clinical labora...
    FEB 19, 2020 11:00 AM PST
    C.E. CREDITS
    FEB 19, 2020 11:00 AM PST
    DATE: February 19, 2020TIME: 11:00am PST, 2:00pm EST...
    Loading Comments...
    Show Resources
    Attendees
    • See more