Sterilization in the Pharmaceutical Industry
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Who Should Attend
This course is designed for pharmaceutical and related
industry personnel who participate in acquiring and preparing
data related to the sterilization technology section of
regulatory filings to the FDA. It is best suited for supervisors,
managers, and directors in many disciplines including:-
Quality Assurance
- Engineering
- Production
- Regulatory Affairs
- Microbiology
This course may also be useful to management personnel
that wish to understand the requirements of sterilization
process validation documentation essential to regulatory
agencies
Description
This course will include discussion on topics such as
container/closure integrity testing, product stability studies,
engineering heat penetration and distribution studies,
container thermal mapping, and environment control
programs. In addition to an overview of moist heat
sterilization, and FDA requirements, the attendees will
participate in the resolution of proposed case studies, and
perform data calculations and graphing exercises to assure
a practical understanding of the sterilization principles and
procedures that will be discussed. Discussions on how moist
heat sterilization is employed during aseptic processing, and
the requirements for moist heat sterilization of aseptic
processing equipment and product components will also be
presented. Emerging regulatory positions in the USA, and
Europe regarding moist heat sterilization will be summarized.
On the final day, the course allows for interactive time to
clarify issues, topics, or offer suggestions regarding actual
situations that the attendees may be encountering.