Always4excellence Tm

Expertise in quality control, quality assurance and regulatory affairs, medical products businesses, chemistry, manufacturing and controls (CMC) section of drug master files, DMFs, analytical methods and process plans, protocols and reports, form FDA 483 and warning letter responses, corrective and preventive action plans, CAPA, deviations, out of spec, OOS, deviation investigations, root cause analysis, trend analysis, systemic issues, significant investigations, fda inspections, fda replies, fda communications, fda responses, quality systems, batch records, end of life decisions, product recall, product withdraw, risk assessment, risk management, FMEA, audits, mock inspections, gap analysis, remediation, training, general cGMP, general validation, and test method validation, negotiations with regulatory agencies, test method characterization and validation, test method validation document evaluation, NDA pre-approval inspections, corrective actions, responses and re-inspection, chemical manufacturing processes, good manufacturing practice (cGMP), total quality management and ISO 9001 registration processes, in vitro diagnostic reagent, instrument design control and quality control. Expertise in drugs, ointments, creams, tablets, aseptic processing, powders, dissolution rate, deformulation, remediation, significant investigations, variances, protocol deviations, preventative actions, corrective actions; quality by design, quality function deployment, design controls, system/component impact assessment, critical process parameters, critical quality attributes, deviation investigation, corrective action and preventative action (CAPAs), quality risk assessment, quality risk management, PMA, 510K and IDE