The 15th Annual Discovery on Target drew record attendance this September 25-29, 2017 with more than 1,300 international participants from 25 countries networking and discussing current and emerging ‘hot’ drug targets for the pharmaceutical industry.
If you are interested in speaking or would like to suggest topics to be covered, please contact Nicole Lyscom, Ph. “This conference provides very deep and broad scientific presentations, roundtable discussions, and excellent networking opportunities for scientists, managers/directors, CROs, vendors and consultants.” - Senior Group Leader, Pfizer “The Immunogenicity and Bioassay Summit covers up-to-date research and regulatory advances on all aspects of immunogenicity.It’s a very good meeting for experts and newcomers to the field.” - Senior Director, Head, Bioanalytical and Biomarker Development, Research & Nonclinical Development, Shire “Program and participants first class.” - Associate Director, Novo Nordisk “Great to get regulatory perspectives on challenges and expectations.The higher level strategic discussions were very informative.” - Beth Arnold, Director, Biologics & Vaccine Bioanalytics, Merck “Breakout interaction with FDA experts was very valuable.” - Associate Director, Alexion Pharmaceuticals Inc.This August in Washington, DC, Cambridge Healthtech Institute’s Ninth Annual Next Generation Dx Summit delivered an inspiring week of updates and collaborative discussion.For many years software development teams have been using Agile Software Development methods, but Agile is not just for software.
Agile’s Lean Product Development principles also apply to the development of hardware-based products and systems.
Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation Post-Course Test.
This optional, one-hour, self-assessment tests your mastery of the course materials and your ability to correctly interpret the Quality System regulation.
This course builds on the concepts in AAMI TIR12, This 3-day course offers participants a comprehensive overview to human factors as it relates to medical devices.
It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device.
Case studies on traceability analysis, requirements writing, test designs, and validation planning give examples and possible solutions to validation activities.