CfPA-The Center for Professional Advancement, Burlingame, CA
October 15-17, 2014
Who Should Attend
This overview course is intended for those having specific responsibilities in the areas of sterile drug product science and technology. It will be of particular value to those in:
• Quality Assurance and Control
Those who wish to broaden their appreciation of these technologies and review the latest developments, as well as managers who have responsibility for a broader base of activities will find the course of interest.
RAPS - Regulatory Affairs Professional Society
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion.
This comprehensive course provides an appreciation and general understanding of the overall contemporary state of science and technology associated with the design, development and manufacturing of sterile drug dosage forms. Emphasis will be oriented toward formulation development and product manufacture of quality sterile dosage forms that meet or exceed expected good manufacturing practice requirements.
||Dr. Gregory A. Sacha; Senior Research Scientist
Dr. Gregory A. Sacha, is a Senior Research Scientist for Baxter BioPharma Solutions in Bloomington, IN. He received a BS in Pharmacy from Butler University in 1993 and earned a PhD in Industrial and Physical Pharmacy from Purdue University in 1999. Dr. Sacha specializes in the formulation of sterile solutions and lyophilized solids for large and small molecules. His research includes thermal characterization of pharmaceutical solutions, development and optimization of lyophilization cycles, and identification of particles through microscopic and spectroscopic methods. Dr. Sacha is experienced in technology transfer, scale-up and process improvement for solid oral and parenteral manufacturing processes and has presented lectures for this course since 2005 in Europe and the United States.