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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,…
Electron Beam Equiment for Sterilizing Medical Devices, and Irradiating Foods, Polymers and Wastes
Expert is one of two partners in a consulting firm. He is the former General Manager of AECL Accelerators. He planned and led the team that developed Atomic Energy of Canada's high energy, high power electron beam technology. He set…
Eye Care, Ophthalmology, Eye Surgery, External Disease, Cornea, Refractive Surgery, Cataract
Expert is an ophthalmologist, with subspecialty training in cornea, refractive surgery, and cornea & external disease. He performs Cataract removal with lens implantation, LASIK laser refractive surgery, Corneal Transplants, Laser surgery and PRELEX multifocal lens implantation for those with bifocal…
Hydrogel Science and Technology for Drug Delivery, Medical Devices and Consumer Products
Expert’s major contributions are in microbial control of wide range of medical devices and pharmaceuticals. He has a background in chemical engineering and polymer science. He has decades of experience from numerous companies- large device and pharmaceutical companies to startups…
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…
Biopharmaceutical Processes
Expert has a BSc. in biotechnology from London (Imperial College) & a Ph.D in cell physiology from Liverpool (UK). Expert has over 20 years experience gained in a wide range of companies in the pharmaceutical and biopharmaceutical fields. He has…
Microbial Contamination Issues
Expert is an expert microbial investigator. He has 10 years of experience as a professional microbiology consultant in the commercial, residential and manufacturing sectors. His lab and team can perform diagnostics with microbial contaminates and manufacturing facilities. He served as…
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,…
Drug Delivery, Formulation Development of NCE\’s, Pre-formulation, Stability, and Clinical Manufacturing
She has been involved in contract manufacturing of pharmaceuticals for the drugs and devices. Contract manufacturing for drugs have included identification, evaluation, screening and selection of CRO's and CMO's in the area of sterile solution and oral solids. For the…
Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles…