Azzur Labs - Events

This four and a half-day class uses lecture, hands-on laboratory work and group activities to provide a review of the facility design, and environmental control requirements of USP Chapter <797> and the NIOSH Alert. The “Engineering Control Performance Verification” section of Chapter <797> is covered in detail. The specific certification procedures outlined in the Controlled Environment Testing Association’s (CETA) CAG-003 are also discussed and utilized for the course’s hands-on workshops. In addition, CAG -001-2005 and CAG-002-2006 will be examined and utilized for the certification of compounding aseptic isolators. Due to the personalized instruction offered, this course is limited in size. Following this class, participants are offered the opportunity to take the CETA Registered Cleanroom Certification Professional Written and Practical exams.

Aseptic Processing and Compliance Tools for USP <797>

September 25th -27th 2012

COURSE DESCRIPTION

The Aseptic Processing and Compliance Tools for USP <797> training modules educate pharmacy and IV managers on how to implement cleanroom principles and practices that comply with USP <797> and industry best practice. Classes are taught in a state-of-the-art facility designed for cleanroom and pharmacy practice demonstration. Topics covered include cleanroom physical design and layout, engineering controls and airflow science, media fill testing, and principles associated with workflow, cleaning, monitoring, validation, staff training and documentation. Attendees completing this program will understand the principles of a USP <797>-compliant facility and how to work in such a facility. Participants will take home sample templates for policies, procedures and documentation that can be customized to their facilities’ needs.