Available Courses:

• Mycoplasma in the Biotech and Pharmaceutical Industries
  February 9, 2009
  This course will introduce the participants to Mycoplasma organisms and how they are a concern in industry.
  
  
• Process Validation for Biopharmaceuticals
  February 9, 2009
  This course is designed to provide an in-depth look at process validation guidelines and best practices. This course will introduce the attendees to critical issues that we face during validation of biopharmaceutical processes.
  
  
• Preparing for an FDA Pre-approval Inspection
  February 9-10, 2009
  This course presents a brief review of FDA inspections that are conducted in accordance with the FDA preapproval inspection program and highlights certain activities that are normally carried out well in advance of the PAI inspection.
  
  
• The Quality System: Design, Implementation, Evaluation and Management of Processes
  February 9-10, 2009
  This course will discuss the characteristics of good process design; the challenges of implementing a new process design, this being the most difficult step, and the culture that facilitates change; how to audit/evaluate processes; and how to manage processes as an integrated system.
  
  
• Achieving cGMP Compliance during Development of a Biotechnology Product
  February 10, 2008
  This participant-interactive lecture is designed to provide attendees guidance on how cGMP regulations and principles should be interpreted and applied from product development through the final stages of biotechnology drug manufacture and approval (preclinical through phase III and validation lots).
  
  
• Bioassay Development and Validation
  February 10-11, 2009
  This course covers the fundamental concepts needed to understand bioassay, bioassay development and validation of bioassays, and reviews the statistical issues and concepts in calibration.
  
  
• Biosystems Fundamentals: Bioreactors, Fermentation and Cell Culture - Theory & Practice
  February 11, 2009
  This course will cover the basic principles of biologics production through the application of fermentation, cell culture, separations and purification techniques.
  
  
• Fundamentals in Biopharmaceutical Microbiology
  February 11, 2009
  The course will provide a general description of the major microbial contaminants - bacteria, yeast, and mold, mycoplasma and bacterial endotoxins of biopharmaceutical products, a survey of microbial monitoring methods used in the industry, and will discuss the role of microbiology in the preparation and maintenance of master/working cell banks, inocula preparation (upstream processing), cell culture/fermentation (upstream processing), isolation, purification, and concentration (downstream processing), bulk preparation, storage, transportation, aseptic filling and isolation (aseptic processing).