Certification of Sterile Compounding Facilities and Aseptic Isolators
October 21-25, 2019 | Totowa, NJ
This four and a half-day class uses lecture, hands-on workshops 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 USP <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.
Who Is This Course For?
Certifiers, Cleanroom Designers, Cleanroom Contractors and anyone designing or building cleanrooms for sterile compounding.
The lead instructor for this course is Jim Wagner, Principal, Controlled Environment Consulting.
Other instructors include:
- Abby Roth, Clinical IQ, LLC
- Mark St. Marie, Prinicpal Consultant, Progeny Consulting Group, LLC
- Jeff Smith, Sr. Manager, Training & Technical Svcs., Controlled Environment Services Inc.| Life Sciences, A Subsidiary of STERIS Corporation
Tuition of $2495 must be paid in full to guarantee a space in the class. Tuition includes: course manual, lunch each day, an Eagleson Institute certificate and a special class reception and dinner with plenty of time to network with peers and instructors.