USP 797

Requirements Needed for Compounding Pharmacies Using USP 797

 

This 4-day course addresses the major requirements for compounding pharmacies for design, operations, microbiology, and aseptic procedures. Compounding pharmacies have had difficulties with these issues and this course will provide an understanding of the subjects. Hands-on activities will also be provided and will include cleaning, garmenting, monitoring, plus more.

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



Course outline

Day One

  1. What are the regulations?
    1. Basic definitions
    2. USP <795>
      1. Overview and what is required
    3. USP <797>
      1. Overview of the sections and what is required
    4. USP <800>
      1. Overview of the sections and what is required
    5. NIOSH HD list 
      1. How to find it
    6. FDA - Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act-Draft
      1. The difference between 503a and 503b per FDA 
    7. FDA 503a license
      1. Review of the regulation and what is required 
    8. FDA 503b license
      1. Review of the regulation and what is required
      2. Overview of 21CFR 210/211
      3. FDA 503b guidance doc review
    9. 2004 aseptic guidance document
      1. Facility
      2. Validation
    10. FDA insanitary conditions draft

Day Two

  1. Facilities
    1. Understanding the cleanrooms — How does it work?
      1. Contamination control basics
      2. Cleanability and materials
      3. Equipment and fixtures
      4. Layouts
    2. Facility systems
      1. HVAC
      2. Water
    3. Design issues — How to correct them
      1. Placement of equipment and return air vents
      2. Laminar flow hoods and biosafety cabinets and placement of those items
      3. Flows — people, material, product, waste
      4. Surfaces
    4. Certification — What is required
      1. Initial tests
      2. Recurring tests
    5. Environmental monitoring/viable sampling
      1. What is it
      2. Air, surface, fingertip (gowning and post media fill) media fill
      3. Setting up a plan
    6. Airflow visualization 
      1. As-built
      2. At-rest
      3. Operational
    7. Aseptic technique
      1. Movement
      2. Contact 
      3. Product path/staging
      4. Supplementary equipment materials
      5. Validation/media fill

Day Three

  1. Environmental Monitoring
    1. Basic microbiology — Understanding contamination for cleanrooms
    2. Testing
      1. NVP
      2. Air viable
      3. Settling plates
      4. Surface sampling
    3. Compliance with regulations
      1. Locations
      2. Frequency
      3. Methods
      4. Equipment
    4. Sterility testing — USP methods
    5. Investigations and CAPAs
      1. How to write and perform
      2. What is needed

Day Four

  1. Operations
    1. People — Source of contamination
    2. Gowning
      1. Types
      2. Procedures
      3. Class and regulation
    3. Cleaning and sanitization
      1. Methods
      2. Disinfectants
      3. Testing
      4. Frequency
    4. Transfer of materials

Who should attend?

  • Compounding pharmacy owners
  • Compounding pharmacy managers
  • Pharmacy technicans
  • Cleanroom designers

 

Course materials

  • Copy of PowerPoint presentation in course binder
  • Copy of USP <797>

Continuing Education Units: 2.4 CEUs

 

Instructors

Gordon Ely
Jan Eudy
Kyle Mulder

 

Next date and location

May 12-15, 2020 - POSTPONED DUE TO COVID-19. New dates will be announced in the coming week.
Excite Pharma Services
324 NW Capital Drive
Lee's Summit, MO 64086
Early-bird discount registration ends March 19. Use coupon code 5EB20CPU to save 10%.
Online registration closes April 27.


 

 

Registration information

Buy 3 Get 1 Free! Register three attendees from your company for the same training course and receive a complimentary fourth registration for another person in your company to attend that course. Contact IEST at 847-981-0100 to arrange this option. (Complimentary registration applies to registration of equal or lesser value. Not valid with any other offers or promotions.)

Registration Fees Regular

 

Member
Non-member
Full-time Government Employees*

 

$2675
$3375
30% discount

 
  • Cancellation Policy is:
    Transfers: Registrations are transferable to another person for the same event. A $35 transfer fee applies. Transfer of a member registration to a nonmember registration will be charged the difference in fees.

    Cancellations: Cancellation requests received 60 days or more prior to the start of the event will receive a full refund LESS a $75 administration fee. Cancellation requests received 30-59 days prior to the start of the event will receive a 50% refund. No refunds will be issued for cancellation requests received less than 30 days prior to the start of the event. IEST reserves the right to cancel course(s), in which case registrants will receive a refund of the fee. IEST is not responsible for any refund or remuneration for hotel, transportation, additional registration fees, tours, or other expenses related to attendance beyond the registration fee refund.
  • Program and instructor(s) are subject to change.
  • All registrations include morning and afternoon breaks and lunch.
  • 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.

*In order to receive the 30% coupon code, government employees must contact IEST at 847-981-0100 prior to registering to show their government ID or proof of government employment. Not valid with any other offers.

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