DESIGNATED PERSON PROGRAM

USP and Certification Compliance for the Designated Person

USP and Certification Compliance for the Designated Person is an immersive 2-day in-person training designed to enhance designated persons' understanding of sterile and hazardous drug compounding area certification compliance. This program combines engaging lectures and hands-on skill-building activities. The morning of each day is spent attending pharmacy specific education sessions, while the afternoons are spent attending the CETA Series sessions. Attendees are also assessed on their understanding of the covered concepts. Those passing the assessment will receive a certificate of competency.

Basic Requirements
Designated person with basic understanding of USP and facility requirements.
Program Highlights & Cost
This program provides not only the necessary training, but also a competency assessment—equipping designated persons with the knowledge and confidence to assess their certification services by:
  • Deep Dive into Certification Standards and Guides – Gain clarity on what industry standards mandate, with a strong focus on highlighting the need for supplemental guidance.
  • What Right Looks Like – Through interactive activities and expert-led discussions, explore certification testing, recognizing what proper testing looks like.
  • Expert-Led Instruction – Learn from industry-leading subject matter experts, who bring real-world experience and insight to the training.

 

The cost to register for this program is $400.00. Register at the "New Registration" link below or add it to your existing registration by clicking "Modify Registration." 

Learning Objectives and Skill Building Activity Descriptions

Day 1 - Friday, April 17 | 8:00am - 12:00pm

Describe the critical elements of USP-compliant cleanroom layout, including airflow, pressure differentials, and HEPA filter placement.

Identify how design choices and the selection of primary engineering controls directly impact certification and contamination control.

Assess facility modifications for compliance risk and required recertification triggers.

List the required cleanroom certification tests required for USP and compliance.

Identify certification tests not described in the USP chapters that are essential for ensuring engineering control functionality and patient safety.

Explain test frequency, methodology, and pass/fail criteria for critical certification tests. Describe what to do when “certification goes wrong.”

In the cleanroom and PECs, the instructors present testing procedures and the use of equipment. Attendees use the equipment and perform the testing with support from the instructors.

Describe certification testing procedures for cleanroom suites and PECs.

List the equipment used in certification testing.

Learning Objectives and Skill Building Activity Descriptions

Day 2 - Saturday, April 18 | 8:00am - 12:00pm

Learn how to verify that certification results meet USP acceptance criteria.

Identify terms and abbreviations associated with certification testing.

Discuss the designated person’s responsibility in identifying incomplete reports or unaddressed failures.

Attendees will be provided with a certification report to review. The goal is to identify errors and missing information. The instructor will review the report, identifying both good and bad elements of the report.

Interpret cleanroom certification reports, including test data, deviations, and technician notes.

Discuss report shortcomings with their certification provider and the necessary remediation steps.

Evaluate a cleanroom certifier’s credentials, experience, and adherence to industry standards and CETA Application Guides.

Identify key red flags and essential contract considerations before engaging a certifier.

Defend provider selection during audits or inspections.

Attendees will complete a multiple-choice assessment. Remediation will be provided onsite. Those that successfully pass the assessment will be provided with a certificate of competency related to the assessment of certification testing and reporting.