ISPE CEUs: 1.3
Type: Classroom Training Course
Sterile Product Manufacturing Facilities: Applying the ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation (T12)
This classroom course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities. The Guide provides valuable information on design, while the USFDA's Guidance helps professionals understand the regulatory context and expectations for sterile drug manufacturing.
Using the referenced documents, this course will cover regulatory philosophy, aseptic process and equipment considerations, aseptic clean room design and operation, differential pressure requirements, airlocks, air filtration, HVAC design considerations, and a brief introduction to barrier isolation technology. (Note: parts of Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice that do not focus on facilities and equipment will not be discussed in detail.)
In addition, the course will include an exercise in the layout of an aseptic filling facility. In many cases, when a new facility is required within an existing or new building, the designer will begin by sketching a floor plan. This exercise will demonstrate how to use process flow diagrams and an accommodation schedule to thoroughly define facility requirements before advancing to the floor plan layout stage.
Take Back to Your Job
Attendance Suggested For
Community of Practice (COP)
This training course is of particular interest to existing and future members of the ISPE Sterile Products Processing (COP).
19 May 2020 - 20 May 2020Rosemount, IL United StatesDaily Schedule
Daily Schedule at a Glance 07:00 – 08:30 Registration Open 08:30 – 17:00 Training Course 10:30 – 11:00 Refreshment Break 12:00 – 13:00 Lunch 15:00 – 15:30 Refreshment BreakInstructors
Mail or Fax Registration
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Group Discount Rate
Bring your team to the ISPE 2020 Biopharmaceutical Manufacturing Conference
- 3 - 5 participants - Save 10%
- 6 - or more participants - Save 20%
Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, firstname.lastname@example.org.