Course Description

This ten-day comprehensive training program, taught by numerous industry leading experts with over 200 years of combined experience in their respective fields, will give you and your personnel the training and information needed to properly evaluate and improve your aseptic processes to ensure sterile product. This course provides the perfect balance of hands-on laboratory and lecture training, equipping you with tools and actual experience you can bring home and apply immediately to your job.

Two five-day sessions allow for an in-depth look into an expanse of topic areas. These two sessions are scheduled approximately four weeks apart, allowing for intense, comprehensive learning with minimal impact on your job/organization.

The first week will cover the fundamentals of aseptic processing, including facility design, velocity testing and airflow studies, basic microbiology, sanitization techniques, environmental monitoring, isolator technology and proper gowning techniques. You will test what you’ve learned by performing two media fills using equipment at TRI’s state-of-the-art facility.

The second week will incorporate information from the first week with more hands-on experience in evaluating media fills, product formulation, CIP systems, rapid microbiological identification, lyophilization, good documentation practices, environmental trending, endotoxin theory and testing, and root cause analysis. The culmination of the ten-day course is the formulation, filling and release of product.

With over 47 hours of hands-on laboratory training and group project work, in addition to extensive coverage of topics during the lecture sessions, this is the most complete aseptic processing training program.

Early registration is recommended as the Aspect Processing Training Programs tend to sell-out quickly!

Who Should Attend

Department
Manufacturing | QA/QC | Engineering

Job Function
Directors, Managers | Leaders | Supervisors | Technicians/Specialists

Learning Objectives

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

• Relate and incorporate each component of aseptic processing into one operation for overall improved process and final product
• Describe the theory behind personnel gowning and aseptic technique qualification to minimize risk of manual product contamination
• Develop working knowledge of component preparation and sterilization to eliminate inherent product contamination risk
• Use proper environmental monitoring techniques combined with a good cleaning and disinfection program to avoid common sources of contamination in your facility
• Incorporate proper documentation practices into aseptic processing program to facilitate regulatory compliance

Key Topics

• Definition and scope of aseptic processing
• Facility design, HEPA certification, velocity and airflow studies
• Aseptic process simulations (media fills)
• Gowning and personnel qualification and good aseptic technique
• Basic microbiology, environmental monitoring and control systems
• Sanitization techniques and sterilization qualification
• Filtration and liquid filter integrity testing
• Reading and evaluating media fills
• Good documentation practices
• Rapid microbial identifications
• Sterility testing and final product testing
• Product formulation and lyophilization
• Use and control of clean in place (CIP) systems
• Environmental data trending and excursion analysis

Faculty

David Matsuhiro, Cleanroom Management Associates, Inc.
David Matsuhiro is the principal for Cleanroom Compliance, Inc. He has worked as a consultant for Aseptic Solutions and KMI Systems, specializing in water, environmental systems and aseptic processing. He has also worked for Genentech, Inc. in a variety of environmental control positions.  Matsuhiro is a member of several professional associations, including PDA, the American Society of Microbiology and the International Society of Pharmaceutical Engineers. He received BS degrees in Microbiology and Chemical Engineering from San Jose State College.

Location/Lodging Information

The course will be held at the PDA Training and Research Institute:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 22804
USA

Contact

James Wamsley
PDA Training and Research Institute
Manager, Laboratory Education
Tel: +1 (301) 656-5900 x200
Email: wamsley@pda.org