Process Validation in the Pharmaceutical Industry

Get an in-depth look at the entire validation cycle in the pharmaceutical industry, writing protocols, determining key operating parameters, establishing ranges for critical quality attributes, and identifying data analysis strategies. You will learn how to interpret the regulations, standards, and guidance documents; correctly apply the principles of risk management; create qualification protocols (IQ, OQ, PQ, PPQ); and identify statistical methods and tools for implementing and maintaining process validation activities.

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Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

Location	Start Date	Days	Cost	Public Course	Private
VIRTUAL DELIVERY (Eastern Time)	09/26/2022	5	$3295.00	Add to Cart	CONTACT US
VIRTUAL DELIVERY (Eastern Time)	12/05/2022	5	$3295.00	Add to Cart	CONTACT US

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

Coming Soon

Virtual Half-Days: 5
In-Person Full-Days: 3
CEUs: 2.4

Related Courses

Coming Soon

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:

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