For safety, every new drug must pass rigorous tests in controlled preclinical or non-clinical studies. Good Laboratory Practices (GLPs) ensure stringent integrity of resulting data, and can determine whether a new chemical entity will enjoy further development or cast aside. COBBLESTONE courses can prepare you to design, develop, structure, source, execute, and analyze studies during this critical discovery phase to give your novel molecule the best chance of success.
To get to market, every new drug must also be shown safe and effective in humans. These controlled clinical studies must be administered in accordance with strict, previously-approved protocols. COBBLESTONE training can help you effectively develop and execute such studies during Phase 1, Phase 2, and Phase 3 drug development for highly successful studies instead of costly failures.
Sterilization Professionals Certification Program
In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of… Continue reading Sterilization Professionals Certification Program
Read MoreEsther Sadler-Williams
Ms. Esther Sadler-Williams is currently the Managing Director of her own clinical supply training and consultancy company, SimplyESW, an organisation that supports clients in enhancing team skills as well as conducting improvement projects to optimize clinical supply chain delivery. Prior to this, Ms. Sadler-Williams was Senior Director of Strategic Alliance Development and Innovation for Catalent… Continue reading Esther Sadler-Williams
Read MoreDavid Long
David Long worked for Rhône Poulenc Health Division (now Sanofi-Aventis) in Quality Assurance (QA) for over twenty years, where he gained considerable experience in all three Good Practice disciplines: GLP, GCP, and GMP. When he left Rhône-Poulenc, he was Senior Director of R&D worldwide for Quality and Process Improvement. Mr. Long has since worked for… Continue reading David Long
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