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Experts in Food and Drug Administration Drug Packaging Regulation| The following experts are available as Food and Drug Administration drug packaging regulation consultants and Food and Drug Administration drug packaging regulation expert witnesses. Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened. | |
| | Definition: Food and Drug Administration Drug Packaging Regulation -
A Food and Drug Administration regulation for the packaging of a drug. Synonyms: FDA drug packaging regulation |
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Expert Quote | | |  | | 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 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 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 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 Medical Products Packaging: FDA Package Validation, Development Standards, Test Methods, ISO 11607
Expert has expertise in the field of medical device packaging for both single use disposable devices and for long-term implantable medical devices. His primary involvement has been in the design, development, and qualification of device ... See full profile | | Minnesota (MN), USA | | | |  | | Expert in Project Management and engineering services for the pharmaceutical and biotech industry.
Expert is a professional in the pharmaceutical and biotech industry with over twenty five years of experience in project management, engineering, construction, and manufacturing operations. His background includes working in the medical device, ... See full profile | | Pennsylvania (PA), USA | | | |  | | Expert in Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due ... See full profile | | Virginia (VA), USA | | | |  | | Expert in Pharmaceutical Regulatory Affairs and Quality Compliance
Expert provides regulatory consulting services to the pharmaceutical, biologics, medical device and food industry to assure compliance with U.S. Food and Drug Administration (FDA) Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs), ... See full profile | | Indiana (IN), USA | | | |  | | Expert in Food Packaging, Retail Products Packaging, Foodservice Packaging, Packaging Materials and Processes
Expert has shown the ability to identify and implement packaging cost savings throughout his career. He reduced the material usage of a cupped pudding product by reducing the plastic cup material thickness while maintaining production line speeds and ... See full profile | | California (CA), 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 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 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 Custom Market Research, Pharmaceutical Industry
With more than 10 years of research experience, the expert has particular expertise in the pharmaceutical industry including Rx and OTC products. Expert has broad experience in FDA-related research as well such as label comprehension research in ... See full profile | | New York (NY), USA | | | |  | | Expert in Flexible Packaging Processes: Rotogravure Printing, Extrusion Coating/Lamianting, Dry Bond
He has experience developing flexible packaging materials utilizing cold seals as sealants. His primary experience is in candy wrappers. He developed simplistic methods for assuring cold seal registration during production runs. He has developed flexible ... See full profile | | North Carolina (NC), USA | | | |  | | Expert in HIPAA, Sunshine Act, Medical, Advisory Board, Brand, Generic, Commercial Pharmaceuticals
Expert is currently Associate Senior Counsel in the U.S. Legal Department of a top-20 pharmaceutical company, where he has worked since 2008. He provides proactive legal support to product teams and client groups across the organization and ... See full profile | | New Jersey (NJ), USA | | | |  | | 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, ... See full profile | | Kent, United Kingdom | | | |  | | 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 Statistics and Data Management; Pharmaceutical Industry
Expert has vast experience in the field of pharmaceutical development. He has been responsible for managing all quality laboratories, and product quality assessment and release to market. He has also evaluated process and product data for 54 drug ... See full profile | | Illinois (IL), USA | | | |  | | Expert in Pharmaceutical Development, Analytical Methods, Method Validation and GMP/Part 11 Compliance
Expert has been involved with cGMPs since their re-release in March 1979. For 7 years during his tenure at Roche he was Compliance and Training Officer for the Technical Development and Kilo Lab Departments, and developed schemes by which the Pilot Plant ... 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 Product Development for Glass & Plastic Packaging for the Cosmetic and Pharmaceutical Industries
He has been involved in package design for the Personal care and Pharmaceutical industry for over 35 years. This involves material choice for product compatibility. Graphics and decorating processes. Packaging line suggestions for modifications for the ... See full profile | | Florida (FL), USA | | | |  | | Expert in Software Quality & Life Cycle, ISO 9000 Standards, Software Regulatory Issues, etc.
Ms. D. Expert has extensive expertise with the maintenance, re-engineering, and reuse of computer software. She has maintained large telecommunications systems and established processes that resulted in effective provision of ... See full profile | | New York (NY), USA | | | |  | | Expert in Pharmaceutical Product Development, Dosage Forms, Controlled Release, QC/QA, GMP, China
Expert has worked in the pharmaceutical industry as a research scientist, QC/QA director, vice president of product development, and has been involved in product development from pre-clinical through Phase 1 production. Expert has experience in setting up ... See full profile | | Oklahoma (OK), USA | | | |  | | Expert in Membranes, Filters, Separations, Validation, Extractables, Leachables
Expert was responsible for building a new manufacturing facility for hollow-fiber thin film composite membranes for industrial gas and liquid. He helped design the equipment, created the plant layout, hired staff, and led the trouble-shooting phase. See full profile | | Oregon (OR), USA | | | |  | | Expert in Packaging Development for Household and Personal Care Products
Expert worked on the development of in-house capability to produce blister card packaging for cosmetic and skin care products. He determined the cause of some blisters with thin skins, while other blisters on the same sheet had "webs;" he also developed ... See full profile | | New York (NY), USA | | |  | | >> Next 25 Experts
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