USP <797> Sterile Compounding and Aseptic Processing Training Program and USP <800> Training for Proper Handling of Hazardous Drugs

USP <797> Sterile Compounding and Aseptic Processing Training Program and USP <800> Training for Proper Handling of Hazardous Drugs	 Banner


Date & Location
Tuesday, August 28, 2018 8:00 AM - Thursday, August 30, 2018 5:00 PM   VCU Smith Pharmacy Building, Richmond , VA

Target Audience
Pharmacist, Pharmacy Technician

Overview

USP <797> Sterile Compounding & Aseptic Processing
August 28-29, 2018
Registration fee:  $795

This certificate program for pharmacists and pharmacy technicians is a comprehensive practice based educational activity designed to provide didactic and hands-on training allowing the participants to develop knowledge and skills necessary to compound sterile products safely and effectively.

Participants will be taught processes and skills required of all sterile product compounders based on current regulations and using situations most likely to be experienced in a sterile compounding environment.  

Participants must successfully demonstrate competency via hands-on simulation using current technology in a state-of-the-art sterile compounding facility.  Immediate feedback is provided by the course directors. 

USP <800> Training for Proper Handling of Hazardous Drugs
August 30, 2018
Registration fee:  $450

Hazardous drugs (HDs) require safe and responsible handling for you and your team, whether medical, nursing, or pharmacy.  USP <800> standards provide oversight guidance on best practices for compounding HDs.  This program reviews current and proposed regulations and recommends best practices concerning all aspects of handling HDs.

This one-day workshop will include:

  • understanding quality systems, process flow and risk assessment;
  • preparing for inspection readiness, and;
  • provide practical application including hands-on skills development and implementation of best practices when compounding sterile and nonsterile HDs.


Objectives

The objectives apply to both pharmacists and pharmacy technicians.
  1. Sterile Compounding and Aseptic Processing Training Program objectives:
  2. Illustrate the chronological evolution of pharmacy compounding up to present day USP Chapters <797> & <800>
  3. Compare the roles of USP and FDA with regard to standards and enforcement
  4. Apply relevant regulatory guidelines associated with pharmacy sterile compounding
  5. Illustrate the typical layout of a cleanroom including primary and secondary engineering controls
  6. Discuss the role of the pharmacist and pharmacy technicians’ responsibilities pertaining to sterile compounding
  7. Demonstrate cleaning and disinfection of pharmacy controlled environments
  8. Demonstrate proper personnel hand hygiene, garbing, gloved fingertip sampling and media fill tests
  9. Compile the similarities and differences between sterile preparations with the various risk levels
  10. Discuss the importance of appropriate beyond use dating principles
  11. ___________________________________________________________________________
  12. USP <800> Compliant Handling of Hazardous Drugs course objectives:
  13. Provide an overview of USP Chapter <800> for hazardous drug compounding
  14. Classify hazardous drugs along with risk assessment and approaches for exposure control
  15. Identify potential challenges with USP Chapter 800 facility design requirements - primary engineering controls and secondary engineering controls - and strategies to address them
  16. Discuss regulatory implications and considerations for operating a 503A Traditional Compounding Pharmacy vs. a 503B Outsourcing Facility
  17. Describe compounding pharmacy scenarios that demonstrate the steps needed to achieve regulatory compliance with current hazardous drug handling standards
  18. Discuss personnel training and competency assessment, personal protective equipment, proper donning and doffing of PPE for compounding hazardous drugs
  19. Discuss best practices for minimizing exposure to hazardous drugs-labeling, packaging, transport, dispensing, spill management, disposal, administering-to prevent occupational exposure to hazardous drugs
  20. Describe proper procedures for deactivating, decontaminating, cleaning and disinfecting primary engineering controls and secondary engineering controls used for compounding hazardous drugs

Registration

USP <797> Sterile Compound and Aseptic Processing Training Program (2-days) Fee:  $795

USP <800> Training for Proper Handling of Hazardous Drugs Course (1-day) Fee:  $450

Both USP <797> and USP <800> (3-days) Fee:  $1,150



Accreditation

Sterile Compounding and Aseptic Processing Training Program

The VCU School of Pharmacy, Office of Continuing Education is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants who attend the entire program, actively participate in exercises and observed demonstrations, and complete an activity evaluation will earn 16 contact hours (1.6 CEUs). 

Activity Type:  Practice

Pharmacist UAN:  0294-0000-18-001-L07-P

Pharmacist Technician UAN: 0294-0000-18-001-L07-T

USP <800> Compliant Handling of Hazardous Drugs

The VCU School of Pharmacy, Office of Continuing Education is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants who attend the entire program, actively participate in exercises and observed demonstrations, and complete an activity evaluation will earn 8 contact hours (0.8 CEUs). 

Activity Type:  Application

Pharmacist UAN:  0294-0000-18-002-L07-P

Pharmacist Technician UAN: 0294-0000-18-002-L07-T