Two-Day Process Validation Training

An effective process validation program is critical in ensuring that manufacturing processes will consistently produce acceptable products and are appropriately controlled. Such a program would ensure that:

1. Manufacturing processes are well-understood
2. Control strategies are implemented to account for all identified sources of variability
3. Each step of the manufacturing process is sufficiently controlled to ensure that the finished product consistently meets the requirements

The application of Process Validation is becoming an increasingly important activity for pharmaceutical and biotech organizations given the critical role validated processes have in ensuring product conformance. To assist industry professionals, several guidelines have been developed by regulatory agencies (FDA, Health Canada, and EMA) in the last few years that define the requirements and best practices for the effective implementation of process validation. Organizations that fail to develop an effective process validation system will face significant regulatory consequences including For Cause audits by regulators, recalls or plant closure. However, the application of process validation is not limited to the manufacturer; it also extends to include suppliers. Regulations have been established which direct organizations to assess the adequacy of process validation activities at their suppliers. For example, regulators expect organizations to begin process validation activities before new equipment is installed.

What You Will Learn

Participants will learn how to develop rigorous protocols and reports, as well as create monitoring programs to ensure that defined critical parameters remain in control. The course will also review validation requirements for systems that generate electronic signatures and records as most new processes have this capability. This training will focus on the practical application of the lifecycle approach to all stages of PV to:

• Understand the importance of product and process understanding and patient requirements.
• Know how to apply QRM tools for PV.
• Recognize opportunities to leverage process design information to establish a process validation strategy and a process performance and product quality monitoring program.
• Understand the challenges to the application of an entirely science- and risk-based approach.
• Understand a variety of approaches to applying specific expectations of the lifecycle approach to PV, including sampling, acceptance criteria, and determining the number of batches for PPQ/PV.
• Understand the differences in expectations among various major world markets.
• Learn various approaches for deciding which attributes and parameters should be evaluated at a heightened level during PV stage 3.
• Understand new expectations for routine process monitoring.
• Understand the process validation lifecycle and the importance of maintaining an effective pharmaceutical quality system.
• Apply process performance and product quality monitoring system elements to identify opportunities for continual improvement.
• Minimize the chance of validation failures by learning about adequate preparation in process understanding and ancillary systems.
• Acquire tools to prepare for a smooth validation execution.
• Understand the implications of validation deviations.
• Maximize and be able to apply your understanding of ICH terminology including the principles of a science- and risk-based approach to the process validation lifecycle.
• Recognize the value of the requirements of management’s responsibilities within the PQS.

Course Content

Overview of Stage 1: Process Development

• Regulatory Climate and Surrounding Changes in Process Validation
• Review of Warning Letters
• Process Validation Basics US and EU
• Similarities and differences between US and EU
• QRM Applied to PV
• FMEA
• Developing Understanding of QbD to Develop Robust Control Strategies (PV Stage 1)

Stage 2: Performance Qualification / Process Validation

• Equipment and Qualification
• Critical Aspects/ Large Molecule
• Statistics for PV
• Control Charting Basics
• Readiness for Process Performance Qualification (PPQ) / PV
• Design of PPQ PV Study Protocol
• Acceptance Criteria, Number of Batches, Sampling Plan
• Acceptance Criteria and Sampling Plans for PPQ
• Acceptance Criteria Sampling Plan

Stage 3: Continued Process Verification / Ongoing Process Verification

• Process Validation / PPQ Execution
• Analyzing Data
• Continued Process Verification (CPV) / Ongoing Process Verification (OPV)
• CPV and OPV Planning
• CPV / OPV for Existing Products
• Comprehensive Case Study

Who should attend

Individuals involved in process validation of products and processes in all sectors of the pharmaceutical industry: Development, manufacturing, engineering, quality, validation compliance, and scientific professionals with intermediate level experience in development, manufacturing, engineering, validation, quality, technology transfer, and those wishing to understand the concept of process validation as a lifecycle.

Education approach

• Lecture sessions are illustrated with examples based on case studies
• Practical exercises include examples and discussions

Speaker

Kossi Molley, Chemist, LSSBB, PMP, Certified Trainer