QDOT ASSOCIATES

Qdot Associates endeavor's to implement its collective experience and expertise spanning over four decades to deliver 'sustainable improvements' by moving beyond services and deliverables through the principles of 'design for compliance. This endeavor is achieved through a holistic life cycle approach for the systems, integrating the processes and aligning the personnel, leading to a desirable state of 'compliance by design. Services: Remediation: • Audit observation • US FDA Form 483 • Warning Letter • Audit Response • Import Alert • Product Recall Investigations: • Root Cause Investigation / Root Cause Analysis • Hypothesis • Interview • Immediate Correction • Corrective Action Preventive Action • Trending • Effectiveness • Complaints • Deviations Data Integrity • ALCOA / ALCOA++ • Attributable - Legible - Contemporaneous - Original - Accurate - Complete - Consistent - Enduring - Available • Data Reliability Training • Analyst Qualification • Technical Training • cGMP Training • Competency Assessment / Building Automation • Training / Learning Management System • Sample Management system • Backup and Archival Management System • Validation & Qualifications • Equipment / Instrument Qualification • Calibration • GAMP • Computer System Validation QbD • Control Strategy • Quality Risk Management • QTPP (Quality Target Product Profile) • CQA (Critical Quality Assurance) • CMA (Critical Material Attributes) • CPP (Critical Process Parameters) • Process Development Report • Product Development • Method Development • Analytical Target Profile • Established Conditions • Design of Experiments • Process robustness Due Diligence (Systems, Facilities, Products) • Pharmacopoeia • Risk-based approach • Gap Assessment