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  • freeCodeCamp - Channel

    • 740 videos
    We're an open source community of busy people who learn to code and build projects for nonprofits.
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  • Analyzing the FDA Process Validation Guidance - Duration: 3 minutes, 29 seconds.

    • 4 years ago
    • 2,528 views
    The US Food and Drug Administration's "Process Validation: General Principles and Practices" is now over three years old. Thus, it is shocking how many pharmaceutical and medical device manufacture...
  • The FDA Perspective on CAPA - Duration: 7 minutes, 20 seconds.

    • 4 years ago
    • 2,507 views
    At IVT's 12th Annual Change Control, Joseph Zec outlined the US Food and Drug Administration's expectations for a company's corrective and preventive action (CAPA), as outlined in Code of Federal R...
  • Understanding the Three Stages of Process Validation - Duration: 5 minutes, 40 seconds.

    • 4 years ago
    • 8,111 views
    While most professionals know there are three stages of the process validation lifecycle, many are unaware of the activities dictated by each stage. As part of IVT's pre-Validation Week webinar, Pa...
  • Post-Validation Change Control and Maintaing the Validated State - Duration: 5 minutes, 15 seconds.

    • 4 years ago
    • 502 views
    "You need to be able to control changes just as much, with as much discipline and robustness as you did the original validation," Joe Zec says during a presentation from IVT's 11th Annual Change Co...
  • Cleaning Validation SOPs - Duration: 10 minutes.

    • 4 years ago
    • 10,751 views
    During a session at IVT's 17th Annual Validation Week, Dawn Tavalsky explained the proper execution of standard operating procedures (SOPs) for cleaning validation. Tavalsky discussed the training ...
  • The Timing of Change Control - Duration: 10 minutes.

    • 4 years ago
    • 480 views
    When to implement change control during the validation lifecycle can be a controversial issue for manufacturers Joe Zec explained during a 2013 presentation at IVT's 11th Annual Change Control conf...
  • Change Control Definitions - Duration: 6 minutes, 44 seconds.

    • 4 years ago
    • 1,109 views
    In the beginning of a presentation entitled "Implement Change Control Procedures During and After Validation," Joe Zec clarifies common change control misconceptions. Quoting the definition of conf...
  • Cleaning Validation Change Control - Duration: 4 minutes, 25 seconds.

    • 4 years ago
    • 233 views
    In the conclusion of a presentation given at IVT's 17th Annual Validation Week, Dawn Tavalsky explained the role of change control in cleaning validation lifecycle. Tavalsky discusses how change co...
  • Writing Validation Requests and Validation Plans - Duration: 14 minutes.

    • 4 years ago
    • 4,775 views
    At IVT's 4th Annual Validation Week EU, Paul Pluta, Ph.D., explains the process of connecting Stage 1 and Stage 2 of process validation through properly written and well formed validation requests ...
  • The Quality System and Implementing Process Validation - Duration: 5 minutes, 50 seconds.

    • 4 years ago
    • 900 views
    In a presentation at IVT's 17th Annual Validation Week, Dawn Tavalsky discusses the true nature of the quality system in respects to validation and clarifies common quality sytem misconceptions. Th...
  • Soil Grouping in Cleaning Validation - Duration: 25 minutes.

    • 4 years ago
    • 265 views
    In this session from IVT's 17th Annual Validation Week, Dawn Tavalsky presented on the basics of soil grouping for cleaning validation. In this comprehensive discussion, Tavalsky explains the diffe...
  • Scope of Cleaning Validation Program - Duration: 7 minutes, 4 seconds.

    • 4 years ago
    • 768 views
    At IVT's 17th Annual Validation Week, Dawn Tavalsky gives a must-see presentation for any organization looking to implement or reimplement a cleaning validation program from scratch. At the beginni...
  • Equipment Grouping for Cleaning Validation - Duration: 8 minutes, 35 seconds.

    • 4 years ago
    • 1,355 views
    "Know and understand the equipment you must clean, its not enough just to know the soils," Dawn Tavalsky expounds in this presentation from IVT's 17th Annual Validation Week. Similar to frying pans...
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