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'SOP' Experts

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Expert in FDA Regulatory Affairs, Compliance and Submissions
Expert is a former FDA reviewer with two decades of industry consulting experience in the following areas: GCP/TMF auditing, SOP writing, regulatory affairs, clinical development, submission preparation for drugs and devices, SAS programming, Part 11 ... See full profile

Maryland (MD), USA

Expert in Anti-Terrorism, Disaster Management, Office Management, FEMA, Security, Emergency Management
He is a military man of 18 years (U.S. Army) and has trained all over the world with various countries in his areas of expertise's. Expert is a U.S. Army veteran of 18 years. Decorated in Desert Storm and Somalia, Expert was a dedicated leader of troops ... See full profile

Arizona (AZ), USA

Expert in Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer's and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic's regulations. See full profile

Quebec, Canada

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 ... See full profile


Expert in Life Sciences, Lab IT Support & Validation
Worked as a group leader as well as R & D Sr.. scientist. Expertise in analytical method development and testing. Worked with NDA and ANDA products with different clients. Directly communicating with clients regarding progress and any problems in ... See full profile

Virginia (VA), USA

Expert in Production and Design of Pharmaceutical Products
Expert Nowaday is working as R&D and QC manager in a pesticides and biopesticides industry. He has 11 years of experience on development and transfer of new pharmaceutical products from R&D into manufacturing. He developed pharmaceutical products as ... See full profile

Mexico City, Mexico

Expert in Chemical Process Engineering
Expert developed expertise in liquid and solid handling while involved in hydraulic and lube oil compounding and processing, in the manufacture of powdered detergent additives, and in pulp processing. See full profile

California (CA), USA

Expert in Facilities Management,Oil & Gas Refinery, Mechanical,Marine,Industrial Engineering, Surveying
Mayraj is a professionally qualified Facilities Management practitioner, Member of Society of Engineer(UK) with over 14 years experience in Total Facilities Management, Property & Asset Management, Project Management, Commercial & Contracts Management, ... See full profile

Dammam, Saudi Arabia

Expert in Process Chemistry: R&D, GC, HPLC, Flash Chromatography, NMR, IR, Mass Spec, & LCMS, Synthetics
He has experience with process research and development, including scale-up to 10- and 15-L reactors. Included in his background is experience with the design, execution, and optimization of multi step organic syntheses aimed at both pharmaceutical ... See full profile

California (CA), USA

Expert in Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals
Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst, an editor ... See full profile

Virginia (VA), USA

Expert in Certified Packaging Professional
Expert is the president of consulting firm that is dedicated to the research, product development, SOP's, protocols, validations and seminars for efficient packaging, medical devices and components that protect products temperature/moisture sensitive ... See full profile

New Jersey (NJ), USA

Expert in Assay Development/Molecular Biology
The expert's private consulting and research company was established to provide innovative solutions to technical problems for researchers in academia and industry. Its charter is to develop strategies and protocols that streamline scientific research in ... See full profile

Indiana (IN), USA

Expert in En Route Air Traffic Control, TRACON Air Traffic Control, Course Manager/Coodinator
This expert has 23 years of experience as an Air Traffic Controller. Working in both the En Route and TRACON specialties he was required to certify on the different types of equipment to safely move traffic through the nation airspace system. See full profile

Kansas (KS), USA

Expert in Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics
PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and ... See full profile

California (CA), USA

Expert in Public Safety Communications and 9-1-1 Center Operations
Expert's areas of expertise include SOP development, training programs, Nex-Gen 9-1-1 implementation, scheduling methods, discipline and management issues. His years of experience in Law Enforcement, Fire, and Medical dispatch centers and 9-1-1 centers can ... See full profile

Florida (FL), USA

Expert in Pharmaceutical Chemical Process R&D, Manufacturing, Disaster Recovery, Software Design
As the IT Manager for a major pharmaceutical company Expert has expertise in selection and validation of document management systems, inventory control, instrument calibration systems, as well as computer software utilized in the pharmaceutical ... See full profile

New York (NY), 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. See full profile

California (CA), USA

Expert in E-beam Imaging Product and Material Development, Laser, FDA Radiation and Product Safety Compliance
Expert is a well-qualified professional with more than 15 years of experience in designing electronic products and materials for high kV electron beam and x-ray imaging applications . He has got extensive knowledge in image processing and ... See full profile

California (CA), 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 of ... See full profile

New Jersey (NJ), USA

Expert in 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 ... See full profile

Tennessee (TN), USA

Expert in Biotechnology, Enzymes, Environmental Bioremediation, Regulatory Compliance
Expert has over 40 years of experience in both basic and applied Biochemistry (biochemical research and enzymology) and Biotechnology. He is very successful in finding flaws in published and spoken materials. His strengths are in the fields of ... See full profile

Illinois (IL), USA

Expert in Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). See full profile

Minnesota (MN), USA

Expert in Plant Biotechnology
Dr. Gaitan-Gaitan has worked in the agriculture biotechnology field, with an ample experience a s a plant breeder and trait development and introgression scientist. He has worked in this field applying modern concepts to combine with the current ... See full profile

Minnesota (MN), USA

Expert in Medical Device Software, Medical Device Software Engineering, FDA Compliance, FDA 501K and PMAs
Expert has wide range of extensive hands on experience developing and manufacturing medical devices. Over the last twenty plus years he has successfully deployed several medical devices in the cardiovascular, opthalmic, and diagnostic industries. See full profile

California (CA), USA

Expert in Brewing
Expert worked in brewing research and quality control for over thirty-one years with Miller Brewing Company. He was a principal research microbiologist for many years with expertise in fermentation, yeast handling, yeast genetics (including genetic ... See full profile

Wisconsin (WI), USA

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