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Pharmaceutical Process Validation Training

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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Brief Overview of This Pharma Process Validation Class

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEU)

2.4

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Training Classes on Pharmaceutical Process Validation

SkillsLab $3295

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive Pharma Validation Class 

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. 

Course Overview
SkillsLab Class

Introduction to Process Validation

  • Process validation requirements: FDA and EMA
  • Process validation guidance: FDA, EMA, and ICH
  • Process validation life cycle

Designing the Process

  • Process validation team
  • Validation master plan
  • Quality target product profile (QTPP)
  • Critical quality attributes (CQAs)
  • Critical process parameters (CPP); Design of Experiments
  • Process design deliverables
Case Study! Introduction to Tablet Coating
Case Study! Determine Attribute Criticality for Tablet Coating
Case Study! Tablet Coating Process Parameters

Risk Analysis

  • Risk management process
  • Sources of risk
  • FMEA
Case Study! Tablet Coating FMEA

Process Qualification I

  • Design qualification
  • Design of a facility
  • Installation qualification
  • IQ protocol, requirements, and steps
  • Operational qualification (OQ)
  • OQ protocol, requirements, and steps
  • Process qualification deliverables
Case Study! IQ Protocol
Exercise! OQ Protocol

Process Performance Qualification (PPQ)

  • Process performance qualification (PPQ)
  • PPQ protocol, requirements, and steps
  • Risk-based statistical methods for data analysis
  • Process stability and capability measures
  • Process performance qualification deliverables
Case Study! PPQ Protocol

Continued Process Verification

  • Process management
  • Control systems to prevent defects
  • Ongoing monitoring
  • Mistake-proofing and automation to eliminate human error
  • Investigations and improvements
Case Study! Summary Report
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

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 the risk, 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 and information

Who Should Attend

Who Should Attend

Recommended for quality, regulatory, engineering, manufacturing, and other technical professionals who plan, execute, report, maintain, review, or manage process validation activities, and who have basic knowledge of statistics or statistical tools. 

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