Resources Section

• What Every Biotech Startup Needs to Know about CMC Compliance
  October 1, 2010 This course will provide insights and practical guidance for a biotech startup to develop an acceptable CMC regulatory compliance strategy for the early clinical stage development (Phase 1 and Phase 2) of their first biopharmaceutical product.
  
  
• Risk Management for Aseptic Processing
  1.5 Day Course, September 30 - October 1, 2010 This interactive course will utilize the PDA Technical Report No. 44 Quality Risk Management of Aseptic Processes methodology to identify, assess, manage, and use risk to make informed decisions in aseptic processing.
  
  
• Integration of Risk Management into Quality Systems
  1.5 Day Course, September 30 - October 1, 2010 This workshop will focus on methods to imbed risk management concepts into elements of the quality systems and utilize current quality data to develop a closed-loop and “living” risk management program.