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Process Validation in the Pharmaceutical Industry

Understand the planning and practical application of tools used in process validation. Learn by doing!

This course provides an in-depth look at the entire validation cycle in the pharmaceutical industry: planning, execution, and reporting of process validation activities. You will learn how to interpret the regulations, standards, and guidance documents; correctly apply the principles of risk management; and identify statistical methods and tools for implementing and maintaining process validation activities. You will practice identifying critical quality attributes, determining key operating parameters, writing qualification protocols, and identifying data analysis strategies.
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Course Detail

What You Will Learn

At the end of this workshop, you will be able to:

  • Explain the purpose, benefits, and objectives of process validation as it relates to assuring drug quality
  • Identify and interpret FDA and ICH requirements for process validation
  • Design and develop a strategy for process control and execution
  • Plan, execute, and report on process validation activities
  • Describe the requirements for process performance qualification (PPQ) and create associated protocols
  • Evaluate risks, consequences, and impacts of validation activities on customers, suppliers, and other interested parties
  • Identify, select, and utilize valid statistical techniques and methods for analyzing data

Who Should Attend

Any quality, regulatory, engineering, manufacturing, and other technical professionals in the pharmaceutical industry who plan, execute, report, maintain, review, or manage process validation activities, and who have basic knowledge of statistics or statistical tools

  • Virtual Half-Days

    5
  • In-Person Full-Days

    3
  • CEUs

    2.4

Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Online Training Schedule

  • This training is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Standard Time.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

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Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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