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Food and Drug Administration drug packaging regulation


Food and Drug Administration regulation


package regulation


Food and Drug Administration compliance


non-hermetic packaging


hermetic packaging


aseptic packaging process


Drug Information Association


Food and Drug Administration drug registration


active pharmaceutical ingredient


Food and Drug Administration National Drug Code


drug labeling requirement


packaging evaluation


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medical product packaging process


packaging equipment


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.  ORC 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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Experts in Food and Drug Administration Drug Packaging Regulation
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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 Food Processing, Packaging, Quality, Business Development, Cost Reduction, Warehousing and Material
Expert is a Food Processing and Packaging Consultant with active membership in the IOPP Packaging Consultants Council, SPE Consultants Circle, and Food and Beverage Industry Executive Advisory Panel Member. He has over 40 years of product, process, and ... See full profile

Florida (FL), 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 GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He 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 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 Flexible Packaging Industry
He has 24 years experience in the expenditure preparation, price negotiation, start up & commissioning of flexible packaging machinery such as extruders, rotogravure and flexography printing, solvent-less and solvent base laminators, slitters, and bag ... See full profile

Alexandria, Egypt

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 Food Science & Technology
Expert is currently a Food Science & Technology Consultant and employed in the private food sector in Jordan. He is an active member in many technical committees for food in JFDA, JISM and Ministry of Environment, and the Ministry of Agriculture. See full profile


Expert in Regulated and Hazardous Materials Auditing, Compliance, Programs, Processes and Training
Expert has utilized his scientific and logistics experience to analyze and consult regarding materials that were thought to be difficult or "impossible" to produce or ship in normal modes commerce. With an intimate knowledge of material and production ... See full profile

South Carolina (SC), 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 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 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 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 FDA, FTC, regulatory, fraud and abuse, e-discovery, OTC, pharma, sunshine act, social media
Expert currently serves as Regulatory Counsel for Allergan, providing proactive legal support to senior management, product brand teams, and client groups across organization, advising and educating on regulations pertaining to pharmaceutical products. 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 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

Florida (FL), 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

Expert in Food Processing and Packaging
During the past 14 years, Expert has had an active research program in aseptic processing and packaging. This program has included university and industry research into package/product interactions, aseptic processing equipment, ... See full profile

Virginia (VA), USA

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