Basics of Designing a USP 797 Compliant Compounding Pharmacy 

This course is available as a custom location training option for your facility.
 
With the recent Drug Quality and Security Act, now is the time to become proactive with FDA inspections. Stop contamination before it starts. Implementing a sterile compounding pharmacy begins with designing a compliant cleanroom. In this course you will learn the basic considerations for the design and environmental control of a compounding pharmacy that is in compliance with USP 797 requirements.

Course outline     Who should attend?     Course materials     Instructor     Next date and location     Registration


Course outline

 

  1. Facility layout and dimensions
  2. Facility materials and sealing
  3. Environmental controls
  4. HEPA/Return locations
  5. Temperature, pressure, and humidity monitoring
  6. HVAC system types
  7. Floors, walls, doors, sinks, and other  considerations
  8. Design for testing compliance rational
  9. Operation and maintenance
  10. FDA inspections of pharmacies and what needs to be done to comply with their inspection recommendations
  11. Questions and answers


Who should attend?

I need to learn how to design a cleanroom that is USP 797 compliant because:

 

 

  • I am an architect designing a new cleanroom
  • I am a pharmacy owner, hospital manager, or building manager
  • I am interested in learning the fundamentals of cleanroom design and construction
  • I am a certifier or manager of a certification company who wants to learn how cleanrooms are built.


Course materials

 

 

  • Copy of IEST-RP-CC012.2: Considerations in Cleanroom Design
  • Copy of PowerPoint presentation in a course binder
  • Certificate of course attendance with completion of CEUs

 

This Recommended Practice (RP), IEST-RP-CC012.2, makes recommendations regarding factors to consider in the design of cleanroom facilities. The RP is intended to provide users with a means to establish performance criteria for cleanrooms. This discussion focuses on those environmental conditions that typically confront cleanroom designers and users. The document includes a sample cleanroom construction protocol.

Continuing Education Units: .6 CEUs

Instructor

Rick Meyer
Mr. Meyer has over 35 years of construction, design, installation, consulting, repair, certification, and maintenance of laboratories, clean rooms, and filtration systems. He has currently been employed with Superior Laboratory Services, Inc. for the last 16 years. He has designed, built, consulted, and certified over 100 USP-797 facilities since 2004, and has tested/certified over 2000 clean rooms, designed/built over 900 clean rooms, and certified over 75,000 hoods to date. He is on IEST Working Groups related to HEPA leak testing, nano facility design, nano- safety, and USP-797 facility design. He is currently a member of the USA, ISO-14644 TAG team that performs reviews and comment on those standards prior to them becoming world wide standards.

Next scheduled date and location

TBA

Registration information

Group discount available. Register three participants from one company and receive a complimentary fourth registration. Don't miss this staff training opportunity! Contact IEST at 847-981-0100 to place these registrations.

 

Registration Fees

Member

Nonmember

Tuesday, April 1
Chicago, Illinois

Early-bird rate
(ends 12/1/13)

Regular rate
(12/2/13-3/30/14)



$585


$665
 



$705


$785

 

 

  • All registrations are transferable to another person for the same event but are not refundable. Notification of transfer must be made at least seven days prior to the event. Transfer fees may be incurred. Exception: IEST reserves the right to cancel courses, in which case registrants will receive a full refund of the tuition fee.
  • All registrations include morning and afternoon breaks.,certificate of attendance, course notes, and a copy of IEST-RP-CC012.2.
  • Documents provided as part of the course are subject to copyright laws. No document may be copied or distributed in any way without the express prior written consent of IEST.
  • Payment must accompany registration; there is no invoicing. IEST does not accept purchase orders as a method of payment.
  • All member dues must be current at the time of registration to qualify for the member rates.
  • All education training courses earn Continuing Education Units.