FDA Guidance, Regulatory Expectations, and Practical Compliance

Process validation is no longer a one-time regulatory requirement-it is a lifecycle-based, science-driven discipline that sits at the core of FDA compliance for drugs and biologics. With increasing regulatory scrutiny, evolving manufacturing technologies, and heightened expectations for data integrity and process control, organizations must demonstrate that their manufacturing processes are consistently capable of delivering products that meet predefined quality standards.

This expert-led webinar is designed to provide a clear, practical, and regulatory-focused understanding of the FDA’s Process Validation: General Principles and Practices guidance. Participants will gain insight into how FDA evaluates process validation during inspections and submissions, and how to design, execute, and maintain a compliant validation program across the product lifecycle-from development through commercial manufacturing.

Whether you are working with small-molecule drugs, APIs, or complex biologics, this session will help you bridge regulatory theory with real-world implementation.

Why Should You Attend?

• Understand FDA’s current expectations for process validation under cGMP
• Learn how to apply the three-stage lifecycle approach effectively
• Avoid common validation gaps that lead to Form 483 observations and warning letters
• Strengthen your regulatory inspection readiness
• Gain practical clarity on validation documentation, protocols, and ongoing monitoring

This webinar goes beyond definitions and provides actionable insights that can be immediately applied to your manufacturing and quality systems.

Topics Covered in the Session

• Regulatory overview of Process Validation under FDA cGMP requirements
• FDA’s Three-Stage Lifecycle Model: Stage 1: Process Design Stage 2: Process Qualification (PPQ), and Stage 3: Continued Process Verification (CPV)
• Identification and control of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
• Designing effective Process Performance Qualification (PPQ) studies
• Risk-based approaches to process validation and change management
• Validation considerations specific to biologics and complex manufacturing processes
• Common FDA inspection findings related to process validation-and how to avoid them
• Documentation expectations, data analysis, and lifecycle maintenance of validated processes

Who Will Benefit from This Webinar?

This webinar is ideal for professionals involved in pharmaceutical and biologics manufacturing, including:

• Quality Assurance (QA) and Quality Control (QC) professionals
• Manufacturing and Process Engineers
• Validation and Compliance specialists
• Regulatory Affairs professionals
• Biotech and pharmaceutical management teams
• Contract manufacturers (CMOs/CDMOs)
• Organizations preparing for FDA inspections or regulatory submissions

Whether you are developing a new product, scaling up manufacturing, transferring technology, or maintaining commercial production, this session will provide valuable regulatory and operational guidance.

Register now to gain clarity, reduce regulatory risk, and strengthen your process validation strategy for drugs and biologics.