Contamination Control Strategy Evaluation and monitoring of Contamination KPIAseptic Core Monitoring. Execution and Monitoring of Media Fill (Aseptic Process Simulation) .Continuous Process Improvement.Smoke Study (Air Flow Visualization study)Handling of Aseptic Observer ProgramEnsure Right first time / First pass success in Regulatory InspectionsHolistic strategy to maintain facility and systems Anytime Ready for Regulatory Inspections. Risk Assessment across Drug Product manufacturing facilities.Ensure risk prevention, mitigation and control actions are implemented and effectiveness monitored to demonstrate State of Control in the facility.Design continuous improvement programs to identify and implement areas of opportunities to prevent contamination in aseptic processing areas.

Good Manufacturing Practices.GxP ComplianceComputer System Validations21 CFR Part 11 Compliance System ControlsRisk AssessmentCompliance Study of Various Pharmaceutical Technology based software with their applicability in different parameters for regulatory compliances ValidationAudit Trail Electronic Records Record Retention, Electronic Signature Legacy Systems

SOP preparation IPQA Activities, QUALITY ANALYSIS, Quality Assurance, CAPA, CHANGE CONTROL.