NHIA Sterile Compounding Clinic

A comprehensive, hands-on training program for today’s sterile compounding professional.

 

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The preparation of sterile products involves specialized training and expertise in environmental controls, aseptic practices, storage and handling, end-product testing, and compliance with established standards and regulations. Pharmacists and technicians play an integral role in training, supervising and assessing adherence to compounding standards for the employees and organizations they represent.

As entities such as the Food and Drug Administration, Boards of Pharmacy, and the Centers for Medicare and Medicaid Services CMS raising the bar for sterile compounding practice, the need for comprehensive employee training is increasing.

The Clinic will merge first-rate classroom instruction with experiential learning inside a simulated compounding lab to offer a real-world opportunity to practice what is learned about hand hygiene, garbing, aseptic technique, and quality assurance program design.



NHIA Sterile Compounding Clinic is ideal for anyone involved in compounding, including Pharmacy Technicians, Pharmacists, Nurses, and Physicians. All participants will receive:

• 40 hours of ACPE-approved CE that will encompass informative, insightful, collaborative, and interactive learning components
• Simulated Compounding Lab for hands-on learning and skills observation by qualified experts
• In-depth review of current and proposed USP standards and how to meet them

• Insight into the FDA’s role in regulating sterile compounding in 503A pharmacies
• A certificate of completion
• Access to all 2018 NHIA Annual Conference general sessions, keynotes, networking events, and entrance to the NHIA Exhibit Hall

Sterile Compounding Clinic

1:00 PM – 5:00 PM

SUNDAY • APRIL 22, 2018

Registration/Check-in is Open

Arriving early? Stop by the NHIA Annual Conference Registration Desk to register or check-in. Pick up your badge, tote bag, and other information. NHIA staff will be there to assist you. Want to explore downtown Phoenix today? See what’s happening around town.

5:30 PM – 7:30 PM

SUNDAY • APRIL 22, 2018

NHIA Annual Conference Welcome Reception

Join old friends and colleagues and welcome new attendees to this year’s NHIA Annual Conference during a meet-and- greet gathering to kick-off this year’s exciting program. Relax and enjoy refreshments, appetizers, and great conversation. hosted by the NHIA Board of Directors in honor of the Future of Infusion Advisory Council.

7:00 AM – 6:00 PM

MONDAY • APRIL 23, 2018

Registration/Check-in (NHIA Annual Conference desk)

7:30 AM – 4:00 PM

MONDAY • APRIL 23, 2018

Sterile Compounding Regulatory Forum

Day 1 of the NHIA Sterile Compounding Clinic (which is also being offered as s a stand-alone seminar for executives and managers) will provide a big picture overview about the current and future state of sterile compounding and will provide essential knowledge regarding the rules and regulations that will impact organizations.
Faculty: Eric Kastango, MBA, RPh, FASHP, President & CEO, Clinical IQ, LLC; Mike Koch, RPh, MBA, Senior Vice President, Professional Services, CAPS; Barbara Petroff, MS, RPh, FASHP; Julie Dohm, JD, Ph.D., Senior Science Advisor for Compounding, FDA

7:30 AM – 8:00 AM

MONDAY • APRIL 23, 2018

Welcome, Announcements, Introductions & Breakfast

Faculty:Connie Sullivan

8:00 AM -8:30 AM

MONDAY • APRIL 23, 2018

The Evolution of Compounding Regulations: How Did We Get Here?

A look back at how sterile compounding standards and regulations have evolved and the milestone events that have led to us to where we are today.
Faculty: Eric Kastango

8:30 AM -9:30 AM

MONDAY • APRIL 23, 2018

The Regulatory Playing Field

An overview of the various entities involved in regulating sterile compounding practice and recommendations for how providers in every setting can navigate the changing landscape.
Faculty: Eric Kastango

9:30AM – 9:45AM

MONDAY • APRIL 23, 2018

Break

9:45 AM – 11:00 AM

MONDAY • APRIL 23, 2018

What’s Wrong with This Picture?

A visual tour of what to do, and what not to do in a sterile compounding practice.
Faculty: Eric Kastango and Barbara Petroff

11:00 AM -11:45 AM

MONDAY • APRIL 23, 2018

The State of Hazardous Drug Compounding Regulations

With the implementation of USP <800> officially delayed and USP <797> still pending, how can providers prepare for new hazardous drug compounding regulations?
Faculty: Barbara Petroff

11:45 AM – 12:30 AM

MONDAY • APRIL 23, 2018

Lunch

12:30 PM – 2:00 PM

MONDAY • APRIL 23, 2018

Compounding Guidance from the Food and Drug Administration

Insights from the FDA regarding the future direction of regulations for 503A and 503B compounders.
Faculty: Julie Dohm

2:00 PM – 2:15 PM

MONDAY • APRIL 23, 2018

Break

2:15 PM – 4:00 PM

MONDAY • APRIL 23, 2018

Is the Future 503B?

This program will examine the evolution of 503B entities and their regulatory requirements so attendees can assess whether registering is right for their business.
Faculty: Mike Koch Final Remarks: Connie Sullivan

4:15 PM – 5:45 PM

MONDAY • APRIL 23, 2018

NHIA Annual Conference Opening General Session

5:45 PM – 7:45 PM

MONDAY • APRIL 23, 2018

Grand Opening Reception – NHIA Annual Conference – Exhibit Hall

Network with colleagues while enjoying complimentary drinks and hors d’oeuvres. This is the prime time for you to visit with a select group of exhibitors that support the home and specialty infusion industry. Visit the Exhibit Hall throughout the week to discover the products and services from the more than 100 companies that will be exhibiting

7:00 PM – 8:00 PM

MONDAY • APRIL 23, 2018

Sterile Compounding Clinic lab

7:00 AM – 9:00 AM

TUESDAY • APRIL 24, 2018

Optional for Sterile Compounding Clinic Attendees

3M Product Tutorial - Management of Central Venous Access Device - Associated Skin Impairment: An Evidence-Based Algorithm
Evidence supporting the assessment and management of central venous access device (CVAD) sites with skin impairment is limited and thus challenging for clinicians. An international advisory panel has published an algorithm to guide the clinician on assessment, identification and prevention of skin injury, contact dermatitis, non-infectious exudate, and exit site infections. This is your opportunity to learn how to maintain your patient’s skin health at CVAD sites.
Faculty: Daphne Broadhurst, RN, BScN, CVAA. Clinical Specialist and Innovations Lead, Medical Pharmacies Group Limited

9:15 AM – 10:15 AM

TUESDAY • APRIL 24, 2018

Sterile Compounding Clinic: Aseptic Practices

This session provides attendees with a comprehensive review of the specific practices and procedures performed under carefully controlled conditions with the goal of minimizing contamination by pathogens during the compounding process.
Faculty: Barbara Exum, Associate Professor and Director, Center for Compounding Practice and Research, VCU School of Pharmacy

10:30 AM – 11:30 AM

TUESDAY • APRIL 24, 2018

Sterile Compounding Clinic: Facility Design & Maintenance

Everything you need to know about how to design a compliant cleanroom facility and create a workflow process based on USP standards and best practices.
Faculty: Mala Crossley, PharmD, VP Payer Relations, Elwyn Pharmacy Group; Marc Stranz, PharmD, Vice President, Clinical, Elwyn Pharmacy Group

11:30 AM – 3:00 PM

TUESDAY • APRIL 24, 2018

Sterile Compounding Clinic: Lab

Attendees will rotate through a simulated lab environment staffed with qualified instructors to demonstrate hand hygiene and garbing, aseptic transfers, cleaning and disinfecting the PEC, conducting smoke studies, taking surface samples, and more. The lab offers a unique opportunity to work in several types of primary engineering controls so attendees can gain experience compounding with different techniques. Attendees can select from ten stations to complete this activity. Attendees must complete at least six (6), 30-minute stations to receive full CE credit for the lab session.
Faculty: Tanya Capleton, Pharmacy Tech, Intramed Plus Home Infusion; Stanley Chamallas, RPh, FASHP, Area Clinical Director, OptionCare; Gene B. Decaminada, RPh, Manager Compounding Compliance, OptionCare; Brenda L. Gray, PharmD, CNSC, BCNSP, Surveyor, Pharmacy Compounding Accreditation Board; Nicholas Heard, CPhT, Materials Management Supervisor, BioScrip Inc.; Michael S. Kirkbirde, PharmD, Area Vice President, OptionCare; Roger S. Klotz, RPh, President/CEO, Care Partners Consulting Pharmacists; Kevin McNamara, PharmD, CNSC, PRS, Owner/Manager, Clinical Pharmacy Partners; Jeffrey A. Reses, RPh, Accreditation Corporate Surveyor, Accreditation Commission for Health Care; Shannon Scott, CPhT, Pharmacy Technician Supervisor, American Outcomes Management LP; Kristen Wolf, PharmD, Home Infusion Pharmacy Supervisor, Kaiser Permanente

3:15 PM – 4:45 PM

TUESDAY • APRIL 24, 2018

Sterile Compounding Clinic: Decontamination, Cleaning and Disinfecting

Take the confusion out of cleaning agents and methods and learn the correct and most efficient way to remove contamination, clean and disinfect your cleanroom facility and equipment.
Faculty: David Nobile, BSME, Senior Technical Services Engineer, Contec Inc.; Mark Wiencek PhD, Lead Microbiologist, Contec Inc

5:00 PM – 6:30 PM

TUESDAY • APRIL 24, 2018

Roundtables

Engage in networking and shared-learning as you discuss common interests, address challenges, and consider critical issues facing your business and the field today.

6:30 PM – 7:45 PM

TUESDAY • APRIL 24, 2018

NHIF Raise the Foundation Cocktail Reception (tickets required).

9:15 AM – 10:45 AM

WEDNESDAY • APRIL 25, 2018

NHIA Annual Conference – General Session

10:45 AM – 1:15 PM

WEDNESDAY • APRIL 25, 2018

Sterile Compounding Clinic: Lab

Attendees will rotate through a simulated lab environment staffed with qualified instructors to demonstrate hand hygiene and garbing, aseptic transfers, cleaning and disinfecting the PEC, conducting smoke studies, taking surface samples, and more. The lab offers a unique opportunity to work in several types of primary engineering controls so attendees can gain experience compounding with different techniques. Attendees can select from ten stations to complete this activity. Attendees must complete at least six (6), 30-minute stations to receive full CE credit for the lab session.
Faculty: Tanya Capleton, Pharmacy Tech, Intramed Plus Home Infusion; Stanley Chamallas, RPh, FASHP, Area Clinical Director, OptionCare; Gene B. Decaminada, RPh, Manager Compounding Compliance, OptionCare; Brenda L. Gray, PharmD, CNSC, BCNSP, Surveyor, Pharmacy Compounding Accreditation Board; Nicholas Heard, CPhT, Materials Management Supervisor, BioScrip Inc.; Michael S. Kirkbirde, PharmD, Area Vice President, OptionCare; Roger S. Klotz, RPh, President/CEO, Care Partners Consulting Pharmacists; Kevin McNamara, PharmD, CNSC, PRS, Owner/Manager, Clinical Pharmacy Partners; Jeffrey A. Reses, RPh, Accreditation Corporate Surveyor, Accreditation Commission for Health Care; Shannon Scott, CPhT, Pharmacy Technician Supervisor, American Outcomes Management LP; Kristen Wolf, PharmD, Home Infusion Pharmacy Supervisor, Kaiser Permanente

1:30 PM – 3:00 PM

WEDNESDAY • APRIL 25, 2018

Sterile Compounding Clinic: Environmental Monitoring

A comprehensive review of the essential elements of a sterile compounding environmental monitoring program in accordance with current and proposed draft United States Pharmacopeial standards. Attendees will also learn how to employ a quality assurance program to demonstrate a “state of control” in all critical areas of the clean room.
Faculty: Abby Roth, BS, CMQ/OE, Director of Microbiology, Clinical IQ LLC

3:15 PM – 4:45 PM

WEDNESDAY • APRIL 25, 2018

Sterile Compounding Clinic – Employee Training & Qualification

Implement a comprehensive employee training and qualification program for working in classified areas and performing aseptic procedures to prepare compounded sterile products in compliance with current United States Pharmacopeial standards.
Faculty: Kurstin M. Peplinski, BS, CPhT, Sr Ambulatory Training Specialist, Fairview Pharmacy Services

5:00 PM – 6:30 PM

WEDNESDAY • APRIL 25, 2018

NHIA Roundtables

7:00 PM – 10:00 PM

WEDNESDAY • APRIL 25, 2018

NHIA NETWORKING EVENT

Join us at Rustler’s Rooste, Arizona’s Legendary Cowboy Steakhouse, for food, drinks, and great conversation. This is a perfect environment to reconnect with old friends and meet new ones while enjoying unparalleled view of the city lights and fun cowboy games.

7:00 AM– 9:00 AM

THURSDAY • APRIL 26, 2018

Sterile Compounding Clinic: Sterility Testing and Determining BUDs

A risk-based approach to determining an appropriate beyond-use-date for compounded sterile products, including parenteral nutrition, in accordance with current and proposed draft United States Pharmacopeial standards. Attendees will also learn about various sterility testing methods used to extend BUDs and when and how to apply them in their operations.
Faculty: Eric Bauer, RPh, Senior Consultant, Central Admixture Pharmacy Services (CAPS)

9:15 AM – 10:45 AM

THURSDAY • APRIL 26, 2018

Sterile Compounding Clinic: Hazardous Drug Compounding

Review the ins and outs of the new USP <800> standard and how to adapt your operation for compliance.
Faculty: L. Rad Dillon, RPh, ASQ CMQ/OE, ASQ CQA, ACHC Surveyor and Pharmacy Consultant, ACHC; Barbara J Petroff, MS, RPh, FASHP, Clinical Services Manager, Soleo Health

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