Agenda: Day One
I. Examine the Fundamentals of Process Validation
• Define key terminology and common acronyms
• Explain what, when, how and why we validate and qualify processes
• Determine the key components of process validation and the validation Lifecycle
II. Comply with Regulatory Requirements for Process Validation
• Review GxPs as related to production and process controls
• Clarify the different levels of validation required by FDA
• Determine the implications of not performing validation and qualification
• Assess latest regulatory trends and identify validation red flagsExercise: Critique Sample 483s and Warning Letters
III. Conduct Process Validation and Equipment Qualification
•Write IQ/OQ/PQ protocols for production processes and equipment
• Perform equipment qualification activities
• Use validation guides, templates and worksheets to collect data
• Learn different methodologies for qualifying equipment and determiningcritical process parameters
IV. Develop and Maintain Adequate Documentation Systems
• Analyze documentation requirements for validation projects
• Examine the Big Three: Validation Master Plan, Validation SOP andValidation Protocol/Summary ReportExercise: Examine and Evaluate a Sample Validation Master Plan
V. Determine the Format and Function of a Validation Protocol
• Outline the parameters and criteria for validation protocols
• Determine the objectives of validation and qualification studies
• Develop and execute various protocols
• Set appropriate acceptance criteria and specifications
• Assess the importance of statistics and quality tools and their relationshipto process validationExercise: Review Sample Validation Protocols
Agenda: Day Two
VI. Develop an Accurate Validation Summary Report
• Determine what to include in the validation report
• Build an appropriate timeline for validation report completion
• Ensure results meet acceptance criteria and testing objectives
• Learn what FDA investigators are looking for when assessing yourvalidation documentationExercise:
Assess Validation Needs by Conducting a GAP Analysis
VII. Establish Effective Validation Programs
• Explain in detail the FDA’s current systems-based inspection strategy
Implement current industry best practices for developing and deployingvalidation programs
• Explain how to perform process validation with emphasis on the validationlifecycleExercise: Analyze Case Studies to Define Requirements for Validation
VIII. Apply Risk Analysis to Process Validation
• Determine the benefits of applying risk analysis in your validation plan
• Review the FDA’s risk-based approach as it relates to validation activities
• Define current industry standard
• Apply risk management principles when selecting validation targetsIX. Monitor and Control Your Validated Processes
• Differentiate between prospective, concurrent and retrospectivevalidation and qualification
• Clarify the difference between revalidation and post-validation monitoringactivities
• Determine what changes should be validated and/or verified
• Comply with FDA expectations for annual product reviews, design