Raphy Bar, BR Consulting, Pharma & Bio Pharma
Roni Cohen, Head of the Microbiology and Chemistry Department, HyLabs
|As we are all expecting an upcoming revision of EU GMP Annex 1, quality control and assurance personnel, regulatory affairs personnel, production personnel and microbiologists exhibit an increasing interest in pharmaceutical microbiology and in monitoring controlled rooms. This seminar will present a mixture of new advances with traditional practices, all related to the controlled environments for production of drug products and medical devices.
After presenting the new changes in the revised ISO 14644 standard for classification of cleanrooms, the new paradigm of USP <1116> of assessing the microbiological quality of controlled rooms will be discussed and compared with the traditional regulatory limits. The novel technique of a continuous real-time monitoring of bio-particles in air will be presented as a potential substitute for the traditional growth-based counting of microbes. Finally, this seminar with present a case study on the practice of monitoring controlled rooms in a sterile product manufacturing facility and will review a systematic investigation of environmental monitoring excursions.
Note: the program and speakers are tentative and subject to change without prior notice.
Microbiologists, production managers, quality control managers, senior management, practitioners of environmental monitoring, QA personnel, RA personnel, and those involved in the preparation of the annual product review will benefit from attending this seminar.
PDA members - 650 NIS
Non members - 850 NIS
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