OverviewThe ultimate goal of FDA Process Validation is to ensure continual assurance that the process once initially validated (PQ now PPQ) and submitted for FDA/EU approval remains in a state of control by detecting unplanned departures from the initially proven acceptable process to meet Current Good Manufacturing Practice requirementsWhy Should You AttendTo gain a current comprehension of the new PV Guidelines and the determination of how to do the required Statistical Monitoring and Data Analysis to prove the process is consistent and to avoid situations that could cause 483s, Warning Letters and Consent Decrees as well as gaining the capability of avoiding rework and recall expenses.Areas Covered In This WebinarProcess knowledge and understanding is the basis for establishing an approach to process control and related instruction sets in the Batch Record for each unit operation and the process overall.Variation can also be detected by the timely assessment of defect complaints, out-of-specification findings, process deviation reports, process yield variations, batch records, incoming raw material records, and adverse event reports. Production line operators and quality unit staff should be encouraged to provide feedback on process performance. We recommend that the quality unit meet periodically with production staff to evaluate data, discuss possible trends or undesirable process variation, and coordinate any correction or follow-up actions by productionThe goal of the third validation stage is continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems for detecting unplanned departures from the process as designed is essential to accomplish this goal Learning ObjectivesProcess knowledge and understanding is the basis for establishing an approach to process control and related instruction sets in the Batch Record for each critical step of the process operation and the overall process results based on statistical database for each batch of that product code. Strategies for process control and operator activities can be designed to reduce variation, adjust for variation during manufacturing and reduced possibility for operator error, as well as an overall blend to manage critical process parameters (CPPs) as well as the original process limits which typically change after the initial validation as well as the trend analysis for each critical step of the process. Who Will BenefitManufacturing Operations ProfessionalsFormulation ProfessionalsEngineering ProfessionalsQA/QC ProfessionalsProduct and Process Development ProfessionalsRegulatory Affairs ProfessionalsResearch and Development ProfessionalsSterility Assurance ProfessionalsTechnical Operations ProfessionalsValidation Professionals FDA inspectors Internal auditorsLevelBeginner