Course Description

Sterile Products: Formulation, Manufacture and Quality Assurance

June 14-17, 2021 | Daily from 7:30am-12:30pm EDT / 13:30-18:30 CEST
Virtual Course

Course Offering 210614VT435
Course ID 435

In-Person Course

Who Should Attend?
This intensive course is intended for those new to the topics of parenteral product development and aseptic manufacturing and those needing a refresher on the topics as well as those seeking confirmation of acceptability of existing practices. It will be of particular value to those in:
• Research
• Development
• Production
• 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.

Course Description
Parenteral product development and aseptic manufacturing can be intimidating to people new to the topics. The approach to formulation and process development is substantially different than for oral and topical medications. Product development and manufacturing must consider how all of the manufacturing processes align to ensure chemical, physical, and microbiological stability with particular attention to proper aseptic technique.

This 18-hour course introduces participants to aseptically manufactured products, routes of administration, and how routes of administration and other requirements affect product development. Interactive discussions are encouraged to ensure questions about the manufacturing processes are raised and different experiences are shared. Demonstrations and practice are offered for gowning, reconstitution of a freeze-dried solid, and preparation of an infusion using proper aseptic technique.

Course Director
Dr. Gregory A. Sacha, Senior Research Scientist for Baxter BioPharma Solutions

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.

ADDITIONAL FACULTY:
James K. (Jamey) Jarman is a Manger of Technical Services for Baxter BioPharma Solutions in Bloomington, Indiana. He has over 25 years of pharmaceutical manufacturing experience, specifically in sterile parenteral manufacturing. Mr. Jarman's background includes aseptic filling operations for vial, syringe, and cartridge products; suspension filling, lyophilized product manufacturing, formulation activities, equipment, and component preparation, and capping related operations. He also has experience in quality assurance, regulatory auditing, technical transfer, and process validation activities. Mr. Jarman received his BS degree from Indiana State University in 1990.

Dr. Jayasree M. Srinivasan is a Research Scientist in the R&D laboratory at Baxter BioPharma Solutions in Bloomington, IN. She received her BSc from University of Madras (India), MS in Synthetic Organic Chemistry from University of Houston, and PhD in Synthetic Organic Chemistry from Indiana University. Her areas of focus at Baxter include formulation (both solution and freeze dried) and process development of sterile products.

Venue Information
Your Computer