Who Should Attend
This is a two-day course for people who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot or commercial setting. The course is ideally suited to industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries.
Learning Objectives
During and upon completion of this course, you will:
- Understand fundamental aseptic facility design principles
- Appreciate what the Food and Drug Administration (FDA) expects of an aseptic filling operation including key differences in other regulated markets
- Better understand aseptic container-closure systems and leak testing
- Know how to properly check equipment and systems in preparation for processing via process simulations - media fills
- Learn the difference between aseptic processing and terminal sterilization
- Learn about the importance of an environmental monitoring program
- Understand the technical fundamentals behind filter sterilization
- Begin to apply risk management strategies to aseptic operations
- Be in a better position to manage your clean room operations
- Appreciate the difference between isolators and barriers
- Know more about lesser-used techniques in aseptic processing
- Understand autoclave cycles and microbiological lethality
- Know about dry heat sterilization and depyrogenation
- Understand gamma and beta radiation sterilization
- Learn about ethylene oxide sterilization
- Know the basics of lyophilization - freeze drying
- Be introduced to radiopharmaceuticals
- Learn where cleaning validation fits in
- Learn about the various types of pharmaceutical water, including water for injection; pure steam generators
- Understand how validation concepts are inter-woven
- Receive practical tips on how to manage your aseptic operations
Course Description
Whether for biopharmaceutical or pharmaceutical applications, this course presents the technical basics that govern aseptic processing and provides practical advice for attendees to troubleshoot and manage their aseptic operations. Although, the course emphasizes industrial microbiology, various types of sterilization, and facility design fundamentals, these subjects are presented in the context of regulatory compliance, Good Manufacturing Practice, and FDA/international current thinking.
Please be aware that this course is designed to address aseptic filling common to biotech and pharmaceutical products. It does not address formulation development, cell culture, fermentation, preparative separations, or similar upstream or downstream processes.
View Course Agenda
Past Participants' Comments
“The instructor was well organized, good flow of material. A lot of good information in the hand-outs and good use of case studies to back up information being presented.”
Kevin M., Project Manager, Commissioning Agents
"Good technical overview given without going into too much detail – questions were encouraged and answered satisfactorily if extra detail was required by attendees.”
Brian O., QA Validation Specialist, Pfizer
"The course notes were very detailed and the instructor very knowledgeable. The material covered will be of immediate use to me when I return to work.”
David I., QA Associate, J&J
"The instructor was energetic and engaging! The material was more relevant than I had expected – an excellent training course for aseptic processing!”
Kent V., Sr. Validation Specialist, Genentech
“The instructor knows the material very well, is up-to-date on FDA regulatory issues with Aseptic Processing and presented very well!”
Mark G., Senior Manager, Pfizer
"The course and Director were excellent. The binder was useful and will be a great reference in the future!”
Gil E., Quality Systems Manager, Biomimetics Therapeutics
"The Course Director was very knowledgeable and used a number of real like examples. He was also very good in encouraging team discussions. The case studies were also very useful. This is the best Aseptic Processing training course I have ever taken!”
Arun S., Engineering Supervisor, Emergent Biosolutions
“Excellent training! The trainer has a deep understanding of the topic and did a great job. The use of training aids was awesome. Overall it was a great training session. One of my friends referred me, and I came from the west coast to attend the course. I am glad that all of my expectations were met!”
Vivek V., Manager, Hollister Stier
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