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Pharmaceutical Manufacturing & Packaging: Sterile Pharmaceuticals, Blow Fill Seal, Liquid Filling, Solids Filling, Facilities & Equipment
Pharmaceutical Industry Expert with over 35 years of experience in all aspects of pharma manufacturing and packaging. He is a leader in manufacturing facilities and equipment, with in-depth knowledge of design, construction, start-up, validation, operations, and maintenance. He is an…
Systems Engineer & Mechanical Engineer
Expert is a proud Systems Engineer, Mechanical Engineer, and research associate with over 15 years of experience performing ground breaking research, analyzing business operations, and supporting business solutions. His aim is to utilize his research, engineering, project management, IT proficiency,…
Sterile Processing Technology
Expert’s formal training and industrial experience have provided him a solid foundation to design optimal heat sterilization processes for foods, pharmaceuticals, devices, biologics, and equipment. His activities in this field include low-acid canned foods, in-container or terminal heat sterilization of…
Sterile Compounding, USP 797/795/800, Home Infusion, TJC/ACHC/BOP Regulations, Healthcare/Change/Project Management, Acute/Hospital Pharmacy Management, Pharmacy Automation, Mail Order Pharmacy, DME
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 operations, finance,…
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…
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. Microbiology Release Testing-Bioburden, Sterility Test, Growth Promotion, Materials Control, Microbial Identification, Bacteria Endotoxin, Biological Indicators Testing,…
Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles…
Validation of Sterilization Processes and USP/AAMI Microbiology, Cleanroom Practices, Aseptics, etc.
Expert has years of experience in validating EO sterilization systems per ISO 11135, Gamma sterilization systems per ISO 11137, and Steam sterilization systems per ISO 11134/17665. This would also include troubleshooting and cycle development issues. He has worked with large…
Aseptic Processing, Aseptic Packaging
Expert has over 35 years of experience in the food-packaging field. His particular expertise is in aseptic packaging. He has consulted with the largest food processors in the world, technically advising on many aspects of aseptic processing and packaging systems.…
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…