A B M Khalid H.

• Providing Quality/Regulatory compliance validation consultancy services to the Pharmaceutical, Medical Device, Clinical Trial CRO, Biomedical, Food & Beverage, Cosmetics, and other Life Science industries. • Quality/Regulatory validation requirement analysis, change control, risk-impact analysis, document control, audit assistance, training, and other QMS documentation services like Quality policy, quality manual, standard operating procedure (SOP), etc. • Validation protocol creation (IQ, OQ, PQ, DQ, URS, FDS, RA, VP, VR, RM, TM, etc.), execution, periodic revalidation, and revalidation after a change using GAMP® 5 risk-based approach on FDA 21 CFR Part 11, Part 21, Part 820, EU Annex 11, GDPR, ISO 13485, 9001, 14001, 45001, etc. for the GxP/cGxP critical facilities. • Computerized system validation (CSV), Test Method Validation (TMV), Industrial/Robotic Process Validation, and FAT/SAT/UAT testing and qualification for prospective, retrospective, and concurrent validation. • DMR/DHF documentation for PROD/DEV environments of Class I and Class II medical devices.