Sterile Non-Hazardous & Hazardous Compounding Certification

The Confidence to Compound Safely — and Compliantly

Home / Sterile Non-Hazardous & Hazardous Compounding Certification

Description

ACHC’s Sterile Compounding Certification Programs provide pharmacists, pharmacy technicians, and compliance leaders with comprehensive training in both:

  • Sterile Non-Hazardous Compounding (USP <797>)
  • Sterile Hazardous Compounding (USP <800>)

Each program combines structured pre-course education with immersive, in-person training in a simulated cleanroom and documented competency assessments aligned with real-world expectations.

Participants don’t just learn requirements—they apply them in a simulated cleanroomcomplete hands-on validation, and must pass both a didactic exam and competency assessments to earn certification.

When compliance is non-negotiable, training must prove it.

Why Attend?

USP <797> & <800> requirements

Practice real-world compounding

Strengthen accreditation readiness

Minimize exposure & contamination risks

  • Sterile Non-Hazardous & Hazardous Compounding Certification

    $2195



    Added to cart

    For: Pharmacists, Pharmacy Technicians, Pharmacists-in-Charge, Branch Managers (including non-pharmacists), and professionals responsible for USP <797> compliance oversight

    Whether your organization requires USP <797>, USP <800>, or both — these certifications provide the training foundation needed to protect patients, staff, and compliance standing.  

AGENDA

Times are subject to change.

Day 1 – Tuesday, November 3

8:00 AM – 8:30 AM: Welcome, Breakfast, Housekeeping, Agenda & Learning Objectives

8:30 AM – 9:00 AM: USP <797> Overview and Designated Person

9:00 AM – 9:30 AM: Training and Competencies

9:30 AM – 11:00 AM: Hand Hygiene, Garbing, and Gloving

11:00 AM – 12:00 PM: Primary Engineering Controls

12:00 PM – 12:45 PM: Lunch

12:45 PM – 2:00 PM: Cleaning and Disinfecting Primary Engineering Controls and Secondary Engineering Controls

2:00 PM – 3:30 PM: Aseptic Technique-Part 1 (Ampules, Liquid Vials, Syringes, Minibags)

3:30 PM – 5:00 PM: Visual Inspection, Labeling, and BUDs

Day 2 – Wednesday, November 4

8:00 AM – 8:30 AM: Breakfast, Agenda & Learning Objectives

8:30 AM – 10:30 AM: Aseptic Technique
• Reconstituting
• Sterilization by Filtration
• Bubble Point Filter Integrity Testing
• Elastomeric Homepumps

10:30 – 11:00 AM: Special Compounding Considerations
• Pediatrics
• Controlled Substances/Pain Management
• Total Parenteral Nutrition
• Inotrope Therapy

11:00 AM – 12:00 PM: Environmental Monitoring

12:00 PM – 12:45 PM: Lunch

12:45 PM – 1:15 PM: Documentation

1:15 PM – 2:30 PM: Fun Games and Hands-On Activities

2:30 PM – 5:00 PM: Didactic Final Examination and Competency Assessments

Day 3 – Thursday, November 5

8:00 AM – 8:30 AM: Breakfast, Agenda & Learning Objectives

8:30 AM – 9:00 AM: General Overview of USP <800>, Designated Person Responsibilities, Hazardous Drug List, and Assessment of Risk

9:00 AM – 10:00 AM: Donning and Doffing Personal Protective Equipment

10:00 AM – 11:00 AM: Facility Design, Deactivation and Decontamination

11:00 AM – 12:30 PM: Aseptic Technique
• Negative-Pressure Technique
• Closed-System Transfer Devices

12:30 PM – 1:15 PM: Lunch

1:15 PM – 2:30 PM: Spill Management, Hazardous Drug Waste, Environmental Wipe Sampling and Medical Surveillance

2:30 PM – 5:00 PM: Hazardous Drug Handling Final Examination and Competency Assessments

Meet the Instructors

Karen Spano, RPh

Karen Spano is the Pharmacy Educator for ACHCU, the education division of Accreditation Commission for Health Care (ACHC). She is a licensed pharmacist with years of leadership experience in infusion and specialty pharmacy, from start-up pharmacies to large pharmacy organizations, supporting organizations through accreditation and regulatory inspections. At ACHCU, she has overseen the development of compounding manuals, updates to the Hazardous Drug Designated Person Certification Program, and creation of a self-assessment tool to determine compliance with USP <795>, <797>, and <800>.

Tammy Blady, RPh

Tammy Blady, RPh, HDDP, is dedicated to ensuring quality and safety measures are upheld across pharmacy operations. With over 35 years in pharmacy, she brings a depth of knowledge to her role as a Corporate Surveyor with ACHC. Her extensive experience — particularly in sterile compounding and hospital and long-term care operations — enables her to connect on a peer-to-peer basis with the pharmacies she serves. Tammy is committed to providing pharmacies a positive, educational accreditation survey experience that promotes a culture of excellence and guides operational and outcome improvements.

Kevn McNamara, PharmD

Kevn M. McNamara is a corporate surveyor for ACHC.

In her roles as an ACHC Surveyor (both full-time and as a contracted surveyor), Kevn has conducted surveys in all pharmacy programs and distinctions. During the time Kevin was a contracted surveyor, she worked in multiple roles as a specialty and home infusion pharmacist, including Performance Improvement Coordinator, Clinical Coordinator, Compliance Officer, Corporate Pharmacist, Pharmacy trainer, Pharmacy Manger, and staff pharmacist. In addition to these roles, she developed policies and procedures and assisted with all phases of the accreditation process from the customer side.

 

Hotel Information

Fairfield by Marriott Inn & Suites Raleigh-Durham Airport/ Research Triangle Park

 Four Points by Sheraton Raleigh Durham Airport