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  • Audit Trail Generation and Review 2019

    Audit Trail Generation and Review 2019

    Other Services Fremont (California) February 22, 2019 150.00 Dollar US$

    Overview: These electronic records must be maintained according to regulatory requirements contained within FDA's 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions. Why should you Attend: Attendees will learn how...

  • Turn a Culture of Quality Into a Competitive Advantage

    Turn a Culture of Quality Into a Competitive Advantage

    Other Services Fremont (California) February 22, 2019 150.00 Dollar US$

    Overview: A culture of quality is a powerful tool for creating an effective and efficient Quality Management System. A culture of quality is not accidental but can be purposefully nurtured and developed. Why should you Attend: Every organization has ...

  • OOS Test Results and Completing [Robust] Investigations

    OOS Test Results and Completing [Robust] Investigations

    Other Services Fremont (California) September 12, 2018 150.00 Dollar US$

    Overview: This training program will describe when a full investigation should be triggered and the frequency for re-testing and re-sampling. Attendees will also learn how to implement corrective and preventive action plans (CAPA). Why should you Att...

  • Mastering Excel [Pivot Tables] in Advanced Technology

    Mastering Excel [Pivot Tables] in Advanced Technology

    Other Services Fremont (California) September 12, 2018 190.00 Dollar US$

    Overview: You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques. Why should you Attend: The PivotTable feature is perhaps Excel's best analytical tool and in ad...

  • Data Integrity in Clinical Trials in [Latest methods]

    Data Integrity in Clinical Trials in [Latest methods]

    Other Services Fremont (California) September 12, 2018 290.00 Dollar US$

    Overview: The clinical data recording process, however, as inspected/audited by inspectors/auditors is initiated with the recorded data, either in the Case Report Form, or in some other system, or in an electronic database. Why should you Attend: Thi...

  • Virtual Seminar on Phase I GMPs

    Virtual Seminar on Phase I GMPs

    Other Services Fremont (California) January 21, 2019 545.00 Dollar US$

    Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. I...

  • Compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR

    Compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR

    Other Services San Diego (California) October 25, 2018 1295.00 Dollar US$

    Description: • This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. • It det...

  • 2-day In-person Seminar Applied Statistics for FDA Process Validation

    2-day In-person Seminar Applied Statistics for FDA Process Validation

    Other Services Philadelphia (Philadelphia, PA) August 8, 2019 2000.00 Dollar US$

    In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates...