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Process Validation Experts| The following experts are available as process validation consultants and process validation expert witnesses. Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened. | |
| | Definition: Process Validation -
Establishing documented evidence that a process, such as nonaseptic pharmaceutical manufacture or water treatment, does what it is purported to do. Synonyms: process validating |
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Expert Quote | | |  | | Expert in Medical Device Sterilization
Expert is an expert in medical device sterilization. He has advanced technical knowledge in all phases of sterilization, including work with heat, chemical, and irradiation sterilization processes. He is especially adept with the irradiation ... See full profile | | South Carolina (SC), 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 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 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 Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management
Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, ... See full profile | | Maharashtra, India | | | |  | | 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 FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action in a ... See full profile | | Michigan (MI), 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 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 Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. See full profile | | Pennsylvania (PA), 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 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 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 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 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 Medical Device, Biotech, Pharma R&D, Tech Transfer, Mfg, Compliance, IP Valuation, Process Improvement
Expert has an impressive and verifiable record of significant product, process and business improvements since 1980. These include: Time to market, new product development system improvement; Reengineering; Business unit performance and profitability ... See full profile | | New Jersey (NJ), USA | | | |  | | Expert in Biopharmaceutical Processes
Expert has a BSc. in biotechnology from London (Imperial College) & a Ph.D in cell physiology from Liverpool (UK). Expert has over 20 years experience gained in a wide range of companies in the pharmaceutical and biopharmaceutical fields. See full profile | | CO. Kildare, Ireland | | | |  | | 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 FDA Regulations, Labeling and Compliance; Medical Devices, Medical Products Liability
Expert has over 35 years medical device industry experience actively involved in the design, development, manufacture, FDA regulation compliance, labeling, and quality control of medical devices. His expertise includes implementation of corporate ... See full profile | | Minnesota (MN), 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 Internal Medicine, Critical Care Medicine, Medical Devices, ICU, Medical Informatics, Startups
Expert is a Pulmonary-Critical Care Medicine physician with experience directly providing patient care in the ICU setting. He has also been an Emergency Physician. Expert was Medical Director of the Medical ICU at The Methodist Hospital in Houston ... See full profile | | Texas (TX), USA | | | |  | | Expert in Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market
She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. See full profile | | Netherlands | | | |  | | Expert in FDA Medical Device Regulation, Expert Testimony
Expert initiately was a FDA field office investigator (drug manufacturing specialist) and compliance officer in the then FDA Bureau of Drugs. During his 17-year career in the FDA Center for Devices and Radiological Health Expert helped to initiate ... See full profile | | North Carolina (NC), USA | | | |  | | Expert in Medical Device Quick Prototyping/CAD Design/Concepting
Expert has designed and developed a cast base for biometric scanning. This base resulted in stable dimensions and functionality when subjected to change in temperature. Scans were used for both hand and finger ... See full profile | | Minnesota (MN), USA | | | |  | | Expert in Manufacturing Automation, Statistical Process Control
Expert has more than thirty years of experience in the analysis of process and manufacturing data aimed at improving product quality and manufacturing process yield. While at DuPont he developed a technology to uncover latent ... See full profile | | Delaware (DE), USA | | |  | | >> Next 25 Experts
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