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.

Target Audience

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

Training Materials

• Presentation slides
• Handouts with key concepts and definitions
• Case studies
• Sample PPQ protocols and reports
• Relevant regulatory guidelines

Speaker

Kossi Molley, PMP, LSSBB, Chemist, Certified Trainer