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Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Sterile Process Validation, Microbiology, Steam Sterilization, Aseptic Filling, Rapid Micro Methods
Expert has over 25 years experience in various aseptic of sterile process validation. She has worked for Baxter, Fujisawa (now Astellas), Jordan Pharmaceuticals, Vectech Pharmaceutical Consultants and Excellent Pharma Consulting. This encompasses steam sterilization, aseptic filling, process validation, development of…
Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems – Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation Research Leadership Team – Four successfully launched peptide/protein…
Pharmaceutical and Biopharmaceutical Product Development, Formulation and Stabilization Technology
Expert has fifteen years of experience in product development, formulation development, and drug delivery for pharmaceutical and diagnostic industries. She has thoroughly developed skills in research planning, product formulation, and analytical problem solving. Expert has expertise in the fields of…
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…
Pharmaceutical Solid Dose Forms
He has worked in the development and manufacturing of chewable tablets either for the delivery of locally (oral) acting drugs with a variety of excipients and basic tableting technology and in the development of medicinal candy products enclosing vitamins flavoring…
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 processes. Expert has developed an airflow visualization procedure to assist the…
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 bringing products…