Course Description

Sterile Products: Formulation, Manufacture and Quality Assurance

September 23-25, 2019
New Brunswick, NJ

Course Offering 190923NJ0435
Course ID 435

In-Person Course

Who Should Attend?
This intensive 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:

  • 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
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.

Special Demonstration by

Hands-on microscopy demonstrations by The McCrone Group on the use of microscopes involving sterile filters and the examination of particulates.

Course Director
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.

Additional Faculty
James K. (Jamey) Jarman is a Technical Transfer Project Manager for Baxter BioPharma Solutions in Bloomington, Indiana. He has over 20 years of pharmaceutical manufacturing experience, specifically in the area of sterile parenteral manufacturing. Mr. Jarman’s areas of focus have included aseptic filling operations for both vial and syringe products, suspension filling, lyophilized product manufacturing, formulation activities, equipment and component preparation, and capping operations. He also has experience in quality assurance, regulatory auditing, and technical transfer activities.

Mr. Jarman received his BS degree from Indiana State University in 1990.

Ruben Nieblas, currently a technical sales representative for McCrone Microscopes & Accessories.

Venue Information
The Heldrich Hotel
10 Livingston Avenue
New Brunswick , NJ 08901 US
Phone: 732-729-4670
Fax: 732-729-4672
Website: The Heldrich Hotel

PLEASE NOTE: Participants must make their own reservations; the cost of hotel accommodation is not included in the course fee. Final hotel information will be emailed to you in your confirmation package approximately 3 weeks prior to the course start date.