COURSE ID 435

Sterile Products: Formulation, Manufacture and Quality Assurance

AVAILABLE On-demand
18 Hours

On-Demand

Offering Price
$ 2800
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Team Training

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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

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 3-day 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.

Great course. Practical detail was given by instructors. Class size allowed for very engaging lecture. All questions were addressed.  D.E., Piedmont Animal Health

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 instructor

Dr. Gregory A. Sacha
Associate Director of R&D for Baxter BioPharma Solutions

Dr. Gregory A. Sacha’s Courses
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.