COURSE ID 435

Sterile Products

Formulation, Manufacture and Quality Assurance

AVAILABLE ON-DEMAND
Duration: 18 Hours
Course Instructor

Dr. Gregory A. Sacha

James K. (Jamey) Jarman

Price
$ 2800
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

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 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

Upon completion of this course, you will be able to:

  • Define the unique characteristics of sterile dosage forms, how these characteristics are achieved and maintained
  • Examine approaches to formulation and process development for parenteral products that include small and large molecules
  • Describe the aseptic manufacturing processes and all unit operations involved in sterile product manufacturing and control, including sterilization, filtration and lyophilization
  • Outline the facility, personnel, and microbial control requirements, fostering an appreciation of the distinctive requirements of sterile products and acquaintance with quality control procedures and international regulations
  • Define the factors affecting aseptic technique and demonstrate the technique
Register Now

You will be redirected to our secure system.

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

James K. (Jamey) Jarman

Manager of Technical Services for Baxter BioPharma Solutions

James K. (Jamey) Jarman’s Courses

Accreditation

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

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.

Learn more

We’ve rebranded! CfPA is now COBBLESTONE