WORKSHOPS

Accreditation University workshops are specifically designed to prepare healthcare organizations for the initial or renewal accreditation process.

USP <800> Compliance Workshop sponsored by PCAB

$499

Upcoming Workshop Dates:

November 8, 2017
Cary, NC


Cary, NC Workshop Hotels/Accommodations

Since the highly-anticipated release of USP <800> there has been much discussion among pharmacies about the interpretation of these new guidelines---and what that will mean for their operations once implementation takes full effect in 2018. During this workshop participants will examine the new standards and discover practical applications.

This workshop will offer CEs.


USP <800> has been recently approved, and all pharmacies should be in compliance by July 1, 2018. Though implementation is not until 2018, the standards are comprehensive and may require significant facility updates. Due to this, the time to start planning is now.

 

Key items addressed include:

 

  • Facility design
  • Creating an OSHA compliant HD List
  • Shipping HDs
  • OSHA Hazardous Communications Programs
  • Respiratory protection
  • Workflow considerations
  • Personnel training
  • Primary Engineering Controls (PECs)
  • Deactivation and decontamination

 

Increasingly, regulators are looking for pharmacies to use a thorough root cause analysis to address out-of-spec results or other issues. Part of the program will consist of interactive exercises with participants developing a root cause analysis and plan of correction for sterile and non-sterile events.

 

 

In addition, USP <797> has issued a revision draft.
We will cover key differences that are critical to your practice including:

  • Changes to how BUDs (Beyond-Use Dates) may be assigned
  • Testing requirements
  • Revised facility requirements
  • Gowning and garbing requirements

 

Learning Objectives:

  • Define what is considered a hazardous drug
  • Provide strategies to achieve USP <800> compliance
  • Review proposed changes to USP <797>
  • Discuss and perform a mock root cause analysis

 

Intended Audience:

This workshop is relevant to sterile and non-sterile compounders.

Your Instructor(s):

Jon Pritchett, Pharm.D.,RPh.
Associate Director, Pharmacy

Bryan Prince, MBA
Compounding Safety, Workflow, and Design Consultant

USP <800> Compliance Workshop Agenda - (8:00am - 4:30pm)

Registration / Continental Breakfast
Introductions/Agenda/PCAB Update
Intro to USP <800> – Protection Not New
How To Read SDS/HD List/What Should be on the List
Break
The Environment – Sterile and Non-Sterile
Lunch / Questions
Decontamination
PPE
Personnel
Receiving and Shipping
OSHA Communication Plan
HD Waste
Break
USP <797> Update
Wrap-up / Questions