Bethesda, Md. - Producing sterile products using aseptic processing technology is challenging and the FDA is aware of these challenges. Therefore the agency places a major emphasis on this area as part of its oversight responsibility.
One way to better produce sterile products is through training in aseptic processing, which is one of the cornerstones of the program offered through PDA’s Training and Research Institute.
In November and December 2013, the PDA Training and Research Institute will offer three courses in aseptic processing – including a new one designed especially for managers.
Quality Systems for Aseptic Processing (November 18 – 22)
This five-day comprehensive training program will give your personnel the tools necessary to optimize your Quality Systems associated with Aseptic Processing. Major topics covered include risk management, sterility by design, troubleshooting and solving sterile filtration issues, investigations and CAPA, and how to effectively implement change within a structured regulated environment.
Management of Aseptic Processing (December 4 – 6)
This course is intended for those in a management role with the responsibility for making business decisions related to aseptically produced products. The course will provide participants with the tools needed to make the difficult business decisions related to aseptic processing. They’ll come away with an understanding of the real costs of aseptic processing (running, maintenance, and compliance costs), what the alternatives are and what the future holds. The course will also provide the students with the knowledge needed to make informed, risk-based decisions.
Fundamentals of Aseptic Processing (December 16 – 20)
This course is intended to provide individuals with an understanding of the fundamental principles governing aseptic processing. It covers the systems associated with aseptic processing and how they work together to help ensure a sterile product. This course is ideal for those who are either new to the industry or new to aseptic processing. Mechanics, HVAC technicians, cleaning and disinfection personnel, and microbiology technicians will also benefit from this course even if they are minimally involved in the aseptic manufacture of drugs, but need to understand the systems associated with it.