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Expert ID: 728217 Maryland, USA

Expert in QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing

Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. Microbiology Release Testing-Bioburden, Sterility Test, Growth Promotion, Materials Control, Microbial Identification, Bacteria Endotoxin, Biological Indicators Testing,…

Expert ID: 726016 New Jersey, USA

Expert in Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization

His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition…

Expert ID: 725858 India

Expert in Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management

Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, projects,…

Expert ID: 724481 United Kingdom

Expert in Pharmaceutical Development, CMC, Project Management, Intellectual Property

Expert has developed modified release products throughout his career. Most recently he led the development of proprietary oral modified release systems at Phoqus Pharmaceuticals. These included zero-order, increasing-rate, pulsatile, delayed-release, chronotherapeutic and fast-release formulations. Prior to that he was responsible…

Expert ID: 724181 Michigan, USA

Expert in FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation

Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action…

Expert ID: 723891 India

Expert in Pharmaceutical Quality Assurance

He possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP’s/ Change controls/ Deviations) as per various regulatory agencies. He had actively participated in various international regulatory inspections (USFDA…

Expert ID: 722341 New Jersey, USA

Expert in Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation

Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the…

Expert ID: 107610 Pennsylvania, USA

Expert in Pharmaceutical Development & Validation

Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in bringing products…

Expert ID: 719293 California, USA

Expert in High Purity Process Engineering

Expert specializes in providing independent technical services to critical process industries such as manufacturing of pharmaceutical products and other specialty chemicals where high levels of purity must be maintained. WATER-TREATMENT FILTRATION PROCESS; CONTAMINATION CONTROL. Expert provides support in process development,…

Expert ID: 734901 Georgia, USA

Expert in Pharmaceuticals

During Expert’s 30 years in Pharmaceutical Research and Development, he developed extensive expertise in novel drug delivery systems and assessing external drug delivery companies while at Parke-Davis/Warner-Lambert, Pfizer and SCD Pharma Consulting. He also managed a team of scientist developing…

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