Al Razi Bldg. 64

Healthcare City, Dubai

+971 4 452 0646

Mon - Fri: 9:00 - 17:30

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Sterile

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 preparations safely and effectively.

Participants Processes

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. ​

The objectives apply to both pharmacists and pharmacy technicians.

 

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

Get in Touch

Phone: + 971 4 452 0646
Email: info@revitalifeacademy.com
Adress: Dubai Healthcare city, UAE

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