Course Description

Sterile Products: Formulation, Manufacture and Quality Assurance

15-17 June 2015
Amsterdam, The Netherlands

Course Offering 1506-302
Course ID 435

In-Person Course

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:

  • 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.

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.

Venue Information
venue
Renaissance Amsterdam Hotel
Kattengat 1
Amsterdam 1012 SZ NL
Phone: + 31 20 621 2223
Fax: + 31 20 627 5245
Website: Renaissance Amsterdam 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.