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pre-approval inspection


'PAI' Experts

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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 Industrial Chemicals, Plastics, and Building Materials
Expert specializes in fluoropolymers (PTFE, FEP, PVDF, ECTFE), high performance polyamides (PAMXD6, PA46, PA4T, PA6T, PA9T, PA10T, and amorphous HPPAs), liquid crystal polymers, polyaryletherketones (PEEK, PEK, PEKK, PEKKEK, PEEK/PBI, PEEK/PPSU), ... See full profile

Massachusetts (MA), 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 Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product ... See full profile

Florida (FL), USA

Expert in Welding, Fabrication, Piping, Pressure Vessels, Shipbuilding, Brazing, Heat / Flame Straightening
He has successfully qualified hundreds of welding procedure qualifications for seam welding. Most notably he has worked with pipe manufacturers in Mexico to implement a 4 wire SAW process for piping longseams. He has been involved with all types of seam ... See full profile

New York (NY), 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 Organic Chemistry, Polymer Chemistry, Photoresists, Photoresist strippers, Sustainability
Expert has over 20 years of experience in developing semi-aqueous strippers/ and cleaners for post-etched wafer substrates. He has developed strippers/cleaners for various metal substrates (such as aluminum, copper, etc.). These strippers were designed to ... See full profile

Pennsylvania (PA), USA

Expert in Facades, Building Envelopes, Glazed Roofs, Glass Structures, Design, QC, Building Commisioning
Expert has almost 40 years of experience in the facade industry and design. His expertise goes from the early stages of the facade design (teaming up with architects for competitions) up the the forensic analysis of existing facades. See full profile

Buenos Aires, Argentina

Expert in Personality-Based Organizational Effectiveness & Development
Expert is a Licensed Clinical Psychologist with a wide range of professional experience in private practice, healthcare, forensic, academic and corporate settings. He is a specialist in psychological assessment and the science of personality, and is ... See full profile

Connecticut (CT), USA

Expert in Drug Delivery, Nutrigenomics/Epigenetics, Molecular Cancer Biology, Mouse Models, Cell Based Assays
Expert completed her PhD in molecular nutrition and cancer biology in the University of Texas at Austin.Throughout her graduate training, she showed initiative and creativity in launching original research projects and her doctoral dissertation was funded ... See full profile

Texas (TX), USA

Expert in Pharma/Biotech Development, Life-Cycle Management, 505(b)(2), Chemical Development, CRO Services
Expert is a Pharmaceutical development leader with ~25 years drug development and manufacturing experience with large Pharma, large Biotech, and a highly successful small start-up. Managed large groups (from three different countries), teams and budgets. See full profile

Illinois (IL), 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 Occupational Safety, Industrial Hygiene, and Ergonomics
Twenty years of experience enables Expert to address the widest variety of occupational safety program issues. He is familiar with the federal regulations as well as the requirements in each of the dozen or so states which mandate written occupational ... See full profile

California (CA), USA

Expert in Pharma Analytical Development, Stability, and QC Lab operations
Extensive use of various analytical techniques for qualitative and quantitative evaluation of small and large molecule compounds. Written many procedures describing in detail how the technique works and how it is to be used with various sample matrices. See full profile

Illinois (IL), 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


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