+Title: AccuReg® - Serving Developers and Manufacturers of Quality Pharmaceuticals, Biologics, Medical Devices, and Diagnostics Since
Description: Not available
Keywords:Food and Drug Administration, FDA, regulatory affairs, engineering, compliance, medical device, pharmaceutical, prescription drug, over-the-counter, OTC, IVD, Good Manufacturing Practices, GMPs, Quality System Regulation, QS Regulation, QSR, Good Clinical Practices, GCPs, Good Laboratory Practices, GLPs, business process re-engineering, BPR, production equipment, qualification, process analysis,
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methods improvement, automated process, process control, GMP audit, clinical audit, design control audit, Quality System audit, QSIT, feasibility, due diligence, product development, regulatory strategy, 483 response, Form FDA 483, Warning Letter, consent decree, injunction, recall, MDR, FDA submission, FDA approval, marketing, pre-approval inspection, PAI, preclinical studies, pharmacovigilence, clinical research, clinical study, clinical protocol, statistics, data management, Investigators Meeting, Investigational New Drug, New Drug Application, Abbreviated New Drug Application, Investigational Device Exemption, Pre-market Approval, Pre-market Notification, Master File, IND, IDE, NDA, ANDA, DMF, 510k, PMA, CMC, registration, listing, complaint handling, adverse event, adverse drug reporting, medical device reporting, CAPA, Standard Operating Procedure, SOP, Master Batch Record, Device Master Record, design history file, requirements management, software requirements, software design, design plan, PDP, software validation, change control, verification and validation, software testing, traceability, SRS, electronic records, electronic signatures, ERES, 21 CFR Part 11, 21 CFR Part 820(View Less)
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