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Current Good Manufacturing Practice Experts| The following experts are available as Current Good Manufacturing Practice consultants and Current Good Manufacturing Practice expert witnesses. Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened. | |
| | Definition: Current Good Manufacturing Practice -
Good Manufacturing Practice implemented in 1976 for the manufacture of products that are under FDA jurisdiction, including pharmaceuticals, biological products and medical devices. Current Good Manufacturing Practice ensures that finished products have the correct identity, strength, quality and purity characteristics they are represented to have, and have not been altered during processing, packaging, or handling. It requires extensive use of documentation and strict reconciliation of inventory. Synonyms: cGMP, Current GMP |
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Expert Quote | | |  | | 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 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 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 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 OTC Drugs, Generic Drugs, New Drugs and General Drug Regulations and FDA Requirements
During his tenure with FDA since 1991, Expert served in the Policy and Guidance Branch of the Center for Drug Evaluation and Research (CDER) with responsibility for the development and interpretation of the Current Good Manufacturing Practice ... See full profile | | Virginia (VA), 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 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 Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems ... See full profile | | California (CA), 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 Consulting
Expert served with the FDA for 20 years. He provided advice and assistance on FDA operations and regulatory policy. Other duties included Warning Letter and FDA-483 reviews and advice, Regulatory Application reviews, advice and drafting; ... 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 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 Pharmaceutical Process Validation & FDA Compliance
Expert is an expert in industrial pharmacy and pharmaceutical process validation. He understands the technology of transferring laboratory pharmaceutical formulations into successful pilot production processes, and high volume production ... See full profile | | New Jersey (NJ), 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 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 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 Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. See full profile | | California (CA), 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 | | | |  | | Expert in Pharmaceutical/Biotech Clinical Trials, Regulatory, R&D, Mergers & Acquisitions, Trends, Outsourcing
Expert is Director of Regulatory Affairs and Clinical Trials managing $3.6 billion at at a pharmaceutical company in New York, NY. His expertise is in managing and deploying outsource/insource teams worldwide for multiple clinical trials and ... See full profile | | Michigan (MI), USA | | | |  | | Expert in Chemistry R&D and cGMP Manufacturing, Pharmaceutical Development
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of ... See full profile | | Massachusetts (MA), 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 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 International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance
Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. See full profile | | Wisconsin (WI), USA | | |  | | >> Next 25 Experts
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