Gmp Iso Expert Services

GMP ISO Experts have been involved with the following services as Retainers, Advisers, Consultants to U.S. and international clients in the Pharmaceutical, Biotechnology, IVD, Dietary Supplement/Food, and Medical Device industries: 1. Performing Gap Analysis of the Quality System against FDA (21 CFR Parts 210, 211, and 820)/ISO regulations or standards and remediation of the Quality System. Preparing site/s for FDA/ISO inspections/audits. Helping clients to write responses to FDA warning letters. Assisting clients with closure of CAPA/Complaints, and Nonconformances. Assisting clients implementing Risk Management (ISO 14971), and creating relevant SOPs. Helping to establish Quality Systems and provide enhancement from ISO 9001 to ISO 13485 to increase profitability for suppliers. Helping to perform audits and manage global supplier performance using a risk-based approach to meet regulatory requirements. Using Lean and Six Sigma methodologies to streamline work processes to improve efficiencies and achieve desired results. Providing ASQ certifications training – Six Sigma Green Belt (CSSGB), Quality Inspector (CQI), Biomedical Auditor (CBA), training. Helping clients with professional staffing services by placing Quality Engineering, Quality Assurance, Quality Control, Manufacturing, and Laboratory candidates in full-time and temporary opportunities.