Process Performance Qualification

Process Performance Qualification

This one-day process validation training session is designed to provide an overview of the latest concepts in Process Validation. The US FDA and EMA have different approaches to Process Validation. Understanding these approaches will provide the best opportunity to develop and implement compliant validation approaches and manufacture or deliver safe products. This comprehensive training program will cover the critical aspects of Process Performance Qualification (PPQ) in the pharmaceutical industry. It will delve into the regulatory requirements, scientific principles, and practical application of PPQ, ensuring participants understand how to effectively plan, execute, and document PPQ studies. The training will utilize a blended learning approach incorporating presentations, case studies, interactive discussions, and Q&A sessions.

Who should attend

This training is designed for individuals involved in pharmaceutical manufacturing, quality assurance, quality control, research and development, and regulatory affairs. This includes, but is not limited to:

Production personnel
Quality assurance personnel
Validation specialists
Process engineers
Regulatory affairs personnel
Laboratory personnel

Key Objectives

Upon completion of this training, participants will be able to:

Understand the regulatory framework governing PPQ (e.g., FDA, EMA guidelines).
Define PPQ and differentiate it from other validation activities (e.g., PQ, PV).
Explain the importance of PPQ in ensuring consistent product quality.
Describe the key elements of a PPQ study design, including process characterization, critical process parameters (CPPs), and acceptance criteria.
Develop a robust PPQ protocol and report.
Understand the statistical approaches used in PPQ data analysis.
Effectively manage deviations and investigations during PPQ execution.
Apply risk management principles to PPQ.
Understand the lifecycle approach to PPQ, including continued process verification (CPV).
Be able to use AI tools to automate PPQ activities.

Training Schedule

Introduction to Validation and PPQ
PPQ Planning and Preparation
PPQ Study Design and Protocol Development
Statistical Approaches in PPQ
PPQ Execution and Documentation
Continued Process Verification (CPV)
Risk Management in PPQ
Case Studies and Q&A

Education approach

Lecture sessions are illustrated with examples based on case studies
Practical exercises include examples and discussions
Throughout the training, participation in discussions and exercises will be assessed.
A short quiz at the end of the training will evaluate the participants’ understanding of the key concepts.