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Mine Safety, MSHA Part 46/48 Training, Audits, Risk Assessment, Accident Investigation
Expert began his mining career in 1966 at a large Arizona underground copper mine. He is a professional mine safety and health consultant with approximately 40 years combined MSHA and industry experience. He owns RMB Consulting Services, Inc., which primarily…
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 Product Development, Dosage Forms, Controlled Release, QC/QA, GMP, China
Expert has worked in the pharmaceutical industry as a research scientist, QC/QA director, vice president of product development, and has been involved in product development from pre-clinical through Phase 1 production. Expert has experience in setting up a cGMP manufacturing…
Manufacturing, Process Development, Machining, Cutting Tools, Innovation, Training
Expert has extensive knowledge and experience in the applications of metal cutting and cutting tools and in research in manufacturing technologies. He has worked and taught for more than 38 years on R&D projects including topics such as: manufacturing process…
Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…
Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…
Life Science, Biotech, Pharmaceuticals: Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization
Expert has over 20 years of experience in strategic innovation, system building, and delivering value solutions for global markets. His focus is on building infrastructure synergies between science, technology, and finance. As a Strategic Advisor, he has experience with: •…
Plumbing System Design; Water Fittings Design; UK Water Regulations; Legionella
Expert has been involved for in Expert Witness work for 30 years. He has been a member of the U.K National Expert Witness Agency. He is a long-standing Member and a Fellow of the Chartered Institute of Plumbing and Heating…
Chemical and Pharmaceutical Development – Comprehensive CMC
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 reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral…
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 industry as a whole. He has…