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PV Detailed Outline


Auditing Biopharma APIs
API GMPs Training
Process Validation
Compliance: Analytical Labs
Compliance: Proc. Development
Part 11 Compliance
Intro to GMPs
API GMPs Overview
Process Val Overview

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Compliance for Biopharmaceutical API Process Validation

Detailed Outline


bulletIntroduction: Regulatory Requirements and Compliance Overview
bulletRegulatory Documents
bulletCompliance Philosophy
bulletProduct Development
bulletTypes of Validation
bulletProcess Validation Program Documentation
bulletProcess Validation Master Plan
bulletConformance Lots
bulletDevelopment Report(s)
bulletStep Reports for each Unit Operation
bulletProcess Change History
bulletFormulation Development
bulletAnalytical Methods History
bulletProcess Validation Support Studies
bulletProcess Validation and Product Approval


bulletEvaluating Critical and Non-critical Process Parameters
bulletCapturing Data
bulletData Evaluation General
bulletCampaign Summaries
bulletDetermining Critical Parameters
bulletProcess Characterization
bulletSetting Ranges


bulletCase Study: FMEA (Failure Mode and Effect Analysis)


bulletQuality by Design: Lab Bench to Market Production
bulletConsiderations for Process Development
bulletCompliance in Process Development Labs
bulletUse of scaled Down Models
bulletExample Process Validation Documents
bulletRaw Material Issues
bulletScale-up Issues
bulletConsiderations for Analytical Laboratories
bulletGeneral Considerations
bulletTesting to Support Process Development
bulletTesting to Support Clinical Manufacturing
bulletAssay Qualification/Validation
bulletTolerances and Uncertainties
bulletTechnology Transfer
bulletQuality Assurance Involvement


bulletCase Study: Evaluating Data to Finalize Parameter Acceptable Ranges and Master Batch Production Records


bulletProcess Validation Support Studies
bulletGenetic Stability
bulletAPI & In-Process Impurity Profile
bulletDNA and Host-Cell Protein Removal
bulletClearance of Process Additives
bulletViral Clearance/Inactivation
bulletProcess Pool Hold Time Studies
bulletBuffer Hold Studies
bulletChromatography Cleaning, Storage & Reuse Studies
bulletMembrane Cleaning, Storage & Reuse Studies
bulletFinal Filter Validation
bulletFinal Bulk Container Validation
bulletShipping Validation


bulletCurrent FDA Issues and Hot Topics
bulletCleaning as a Process
bulletMatrix Approaches
bulletMaintaining the Validated State
bulletDesign Qualification


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Did you know?

If Process Validation program deficiencies are found during FDA's product review or PreApproval Inspection, it typically results in approximately a one year delay to approval of a new product.


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