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Good Manufacturing Practice Experts| The following experts are available as Good Manufacturing Practice consultants and Good Manufacturing Practice expert witnesses. Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened. | |
| | Definition: Good Manufacturing Practice -
A collection of regulations published by the FDA that express accomplishment objectives and requirements in design and utilization of facilities and equipment, training and supervision of personnel, storage and control of materials, processing and packaging of products, and maintaining of records of all manufacturing and control activities to assure the manufacture of safe, sanitary, effective or wholesome, and truthfully labeled and packaged products. Synonyms: GMP |
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Expert Quote | | |  | | Expert in GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
I am a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; I acquired more than 21 years' experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects ... See full profile | | Québec, Canada  | | | |  | | Expert in Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant ... See full profile | | Illinois (IL), USA | | | |  | | Expert in Medical Device Software, Medical Device Software Engineering, FDA Compliance
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 FDA Compliance, Pharmaceutical New Products, Management Training, Seminars, Inspections, Audits
During his employment with the Food and Drug Administration, Expert received five grade promotions, with his last position being that of Director of the Science Branch of the Philadelphia District. Expert's area of responsibility included all the ... See full profile | | Georgia (GA), USA | | | |  | | 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 | | India | | | |  | | Expert in Pharmaceutical Technology, Scale-up, Wet granulation end-point, Tableting, Compaction
Expert has 25 years experience in pharmaceutical process scale-up, wet granulation end-point determination, compaction and tableting. He has published many articles on these topics, edited "Pharmaceutical Process Scale-up" handbook, and wrote chapters ... See full profile | | New Jersey (NJ), 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 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 to the ... See full profile | | Germany | | | |  | | Expert in Hatch-Waxman patent litigation, CMC Pharma Dev Issues, Preformulation/Formulation, Regulat-Reports
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal ... See full profile | | Florida (FL), USA | | | |  | | Expert in GMPs for Drugs, Devices, Biologics
The primary focus of Expert's career has been to establish documentation systems that support the quality assurance requirements of GMP and ISO regulations for product development and commercial manufacturing. See full profile | | Minnesota (MN), USA | | | |  | | Expert in Manufacturing and Distribution in Food, Beverage and Nutitional Supplement Industries
Expert has extensive expertise in the Food, Beverage and Nutritional Supplement industries in the areas of manufacturing, suppy chain, planning, packaging, warehousing, distribution and custmer service from the floor level through Executive Management. See full profile | | South Carolina (SC), USA | | | |  | | Expert in In-Process Analytical, cGMP Auditing, Polymer Characterization, Analytical Lab Design and Management
Expert has 32 years of industrial analytical chemistry experience. For the last 24 years of that period, he headed the analytical R&D organization of International Specialty Products, a $1.7B specialty chemical company (as of 2007). See full profile | | New Jersey (NJ), 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 ... See full profile | | New Jersey (NJ), USA | | | |  | | Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, ... See full profile | | California (CA), USA | | | |  | | Expert in OTC, Generic, and New Drugs, Medical Device Regulations
Expert now consults clients on matters pertaining to OTC drugs, generic drugs, new drugs and devices regulations and performs inspections of manufacturing facilities for compliance with current Good Manufacturing Practice Regulations. See full profile | | Virginia (VA), USA | | | |  | | Expert in Product Approval and GMP Compliance to Medical Device Regulations
As compliance officer with the CDRH's Office of Compliance, expert was responsible for evaluating results of foreign and domestic inspections conducted by the agency based on current Good Manufacturing Practice Regulations. His experience with the FDA has ... See full profile | | Virginia (VA), USA | | | |  | | Expert in Pharmaceutical Product Development and Good Manufacturing Practices (cGMP, IQ/OQ, CMC, FDA, etc.)
Expert is a consultant to the pharmaceutical and allied industries. His background includes 28 years with DuPont and DuPont Merck in a variety of positions. In his last assignment at DuPont Merck, he was Senior Director of Technology and Engineering in ... See full profile | | New Mexico (NM), USA | | | |  | | Expert in Quality Assurance, Regulatory Affairs, Marketing and Business Strategy for Life Sciences Industry
He has performed compliance audits to 21 CFR Part 11. He has developed qualification protocols to test systems compliant with 21 CFR Part 11. He has developed advertising campaigns, written copy for advertisements and managed the creative development of ... See full profile | | Montana (MT), USA | | | |  | | Expert in FDA Audit, FDA Regulation, GMP
Expert has more than 41 years of inspection experience to offer. He served 32 years with FDA and another 9 years conducting audits and serving as a consultant of FDA regulated industries throughout the United States for AAC/Kendle before joining EAS as a ... See full profile | | Virginia (VA), USA | | | |  | | Expert in Regulatory Compliance Auditing, Training; FDA NDA/ANDA and DEA QA and Drug Inspections, Approvals
Expert is an internationally recognized authority on GMP and ISO auditing. In 1984 he authored the GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers. In use by over 8000 companies worldwide, and translated into ... See full profile | | Illinois (IL), USA | | | |  | | Expert in Biomedical Device Engineering
Biomedical product development; medical device product development; new product development. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. See full profile | | South Africa | | | |  | | Expert in FDA Medical Device Quality Systems, Governmental Registration Process, International Business, GMP
As an ex-FDA official for over 21 years (not only as a experienced investigator/analyst, but also when he acted as field and HQ compliance officers during details to these offices), Expert is highly familiar with FDA compliance. He retains this knowledge ... See full profile | | Pennsylvania (PA), USA | | | |  | | Expert in Medical Device Design Control and Software Validation
Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product ... See full profile | | New Jersey (NJ), USA | | | |  | | Expert in Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and ... See full profile | | Illinois (IL), USA | | | |  | | Expert in Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet ... See full profile | | Massachusetts (MA), USA | | |  | | >> Next 25 Experts
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