Introduction: Regulatory Requirements and Compliance Overview Regulatory Documents Compliance Philosophy Definitions Product Development Types of Validation Process Validation Program Documentation Process Validation Master Plan Conformance Lots Development Report(s) Step Reports for each Unit Operation Process Change History Formulation Development Analytical Methods History Process Validation Support Studies Process Validation and Product Approval
	Evaluating Critical and Non-critical Process Parameters Capturing Data Database Data Evaluation General Campaign Summaries Determining Critical Parameters Process Characterization Setting Ranges
	Case Study: FMEA (Failure Mode and Effect Analysis)

Quality by Design: Lab Bench to Market Production Introduction Considerations for Process Development Compliance in Process Development Labs Use of scaled Down Models Example Process Validation Documents Protocols Reports Raw Material Issues Scale-up Issues Considerations for Analytical Laboratories General Considerations Testing to Support Process Development Testing to Support Clinical Manufacturing Assay Qualification/Validation Tolerances and Uncertainties Technology Transfer Quality Assurance Involvement

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

	Process Validation Support Studies Genetic Stability API & In-Process Impurity Profile DNA and Host-Cell Protein Removal Clearance of Process Additives Viral Clearance/Inactivation Process Pool Hold Time Studies Buffer Hold Studies Chromatography Cleaning, Storage & Reuse Studies Membrane Cleaning, Storage & Reuse Studies Final Filter Validation Final Bulk Container Validation Shipping Validation
	Current FDA Issues and Hot Topics Cleaning as a Process Matrix Approaches Maintaining the Validated State Design Qualification

 

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