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Related Expert Areas

  

process validation

  

validation

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aseptic pharmaceutical process validation

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nonaseptic pharmaceutical process validation

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medical device process validation

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cleaning validation

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pharmaceutical water treatment system validation

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active pharmaceutical ingredient

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pre-approval inspection

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pharmaceutical manufacturing

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Food and Drug Administration validation

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medical device inspection

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medical device soldering

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Medical Device Reporting regulation

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medical device reporting

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medical product manufacturing

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pharmaceutical manufacturing facility auditing

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drug validation

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sterile

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process modeling

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sterility

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process hazard analysis

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computer-system validation

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hazard analysis critical control point

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process

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medical equipment

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Process Validation Experts

The following experts are available as process validation consultants and process validation expert witnesses.  ORC 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 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 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 Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain
Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields ... See full profile

Massachusetts (MA), USA

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. He has significant experience in ... See full profile

Pennsylvania (PA), USA

Expert in Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, ... See full profile

Washington (WA), 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 Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)
After receiving a PhD in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and ... 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 in ... See full profile

New Jersey (NJ), 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 Pharmacy/Pharmaceuticals, Healthcare Management, and Hospital Pharmacy Management/Clinical
Expert is an experienced PharmD, Director of Pharmacy and Assistant Clinical Professor with 6 years of experience at small, medium, large, level 1 trauma academic, acute care and long-term acute care hospitals. She has deep experience in pharmacy ... See full profile

California (CA), 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, and 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 and ... 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 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

Expert in Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. See full profile

Oklahoma (OK), USA

Expert in High Purity Process Engineering
Expert specializes in providing independent technical services to critical process industries such as manufacturing of pharmaceutical products and other specialty chemicals where high levels of purity must be maintained. See full profile

California (CA), USA

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