Aventura, FL – March 29, 2019

Aventura, FL US
March 29, 2019

Are you up to date with current regulations? Is your compounding pharmacy compliant? Never assume – the likelihood of having your pharmacy inspected continues to increase.

Over the last few years, pharmaceutical compounding has come under increasing federal and state regulatory scrutiny and oversight due to the inherent risks involved in this practice. As such, new laws and standards have been introduced for both sterile and non-sterile compounding to ensure patient safety and prevent future outbreaks. While these standards are vital to protecting and promoting public health, many compounding pharmacies struggle to keep up with all the changes and sometimes conflicting requirements. Our workshop will provide you with the resources needed to keep you up to date with current guidelines and regulatory standards. By attending our training, not only will you maintain your commitment to quality, you will also be able to incorporate the practical changes required to meet or exceed compliance with the latest sterile and non-sterile compounding laws and regulations. 


Intended audience


  • Pharmacists and Pharmacy Technicians
  • Pharmacy Managers
  • Auditors and Inspectors
  • Quality Assurance Officers
  • Compliance Specialists

Learning Objectives

FOR PHARMACISTS:
  1. Review current Federal guidance documents, State Board of Pharmacy standards, and best practices in the compounding industry.
  2. Identify USP requirements for sterile, non-sterile, and hazardous drug compounding. 
  3. Prepare for a State Board of Pharmacy inspection, FDA inspection, or accreditation audit.
  4. Manage a step-by-step process required to thoroughly self-inspect your pharmacy.
  5. Describe key compliance indicators to assess during your pharmacy walkthrough.
  6. Organize recordkeeping and pharmacy documentation.
  7. Recognize the importance of a quality improvement plan.
  8. Develop corrective and preventive action plans.
  9. Examine standard operating procedure requirements.
  10. Discuss the legal and ethical consequences of non-adherence to compounding standards and requirements.
FOR TECHNICIANS:
  1. Review current Federal guidance documents, State Board of Pharmacy standards, and best practices in the compounding industry.
  2. Identify USP requirements for sterile, non-sterile, and hazardous drug compounding. 
  3. Prepare for a State Board of Pharmacy inspection, FDA inspection, or accreditation audit.
  4. Outline a step-by-step process required to thoroughly self-inspect your pharmacy.
  5. List key compliance indicators to assess during your pharmacy walkthrough.
  6. Organize recordkeeping and pharmacy documentation.
  7. Describe the importance of a quality improvement plan.
  8. Implement corrective and preventive action plans.
  9. Apply standard operating procedure requirements.
  10. Recognize the legal and ethical consequences of non-adherence to compounding standards and requirements. 

FINANCIAL SUPPORT:

This learning activity has received financial support from MEDISCA Inc. in the form of an educational grant.


COPYRIGHT:


The live activity workbook is copyright © 2016 LP3 Network.

Course summary
Available credit: 
  • 0.80 CEU (ACPE)
  • 8.00 Contact Hours
Event starts: 
03/29/2019 - 8:00am
Event ends: 
03/29/2019 - 5:00pm
LP3 Network Facility
21550 Biscayne Blvd
Suite 300
Aventura, FL 33180
United States
Cost:
$595.00

Travel information

Venue information: 


The training will take place at our state-of-the-art Learning Center.

Driving/Parking Instructions: If you are planning to drive in directly to the facility, please use the map/directions link provided below. Limited free parking is available at our training facility* and the preferred hotel accommodation, which is conveniently located next door to the facility.

*Please note, in order to park at our training facility on Saturdays and Sundays, you must press the intercom button at the parking garage gate and mention that you are attending a training with LP3 Network; easiest access to the facility (Suite 300) is through the parking garage on the 4th floor.

LP3 Network Facility
21550 Biscayne Blvd
Suite 300
Aventura, FL 33180
United States

Hotel information: 

The preferred hotel accommodation is the Hampton Inn Hallandale Beach Aventura

For reservations, please call 1-888-871-3430 or to book online, click here

Based on Availability. Payment for hotel accommodations is at the expense of the activity participant. 

Hotel Location: 
Hampton Inn Hallandale Beach Aventura
1000 South Federal Highway
Hallandale Beach, FL 33009
United States

JOE CABALEIRO, BS Pharm, RPh
Senior Associate, Gates Healthcare Associates
Disclosure: Accreditation Commission for Health Care, Consultant; Gates Healthcare Associates, Consultant; Healthrx Group, Consultant; MEDISCA, Consultant

Mr. Cabaleiro is the former Associate Director of Pharmacy for the Accreditation Commission for Health Care (ACHC); responsible for the development of compounding quality standards. He is also the former Executive Director for the Pharmacy Compounding Accreditation Board (PCAB), and a former surveyor for the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). In addition, Mr. Cabaleiro has served on the United States Pharmacopeia’s Council of the Convention.

A pharmacist for more than 30 years, Mr. Cabaleiro is a nationally recognized expert in non-sterile and sterile compounding, pharmacy quality, accreditation standards, and compounding pharmacy management and operations. Mr. Cabaleiro began his career in home-infusion therapy as pharmacy manager. In 1982, he developed an innovative compounding computer system used nationwide that combined a notebook computer, barcode reader, and electronic balance to permit the safe preparation of complex total parenteral nutrition solutions. He served multiple facilities in the roles of operations and general management during this period of his professional career.

In 1989, Mr. Cabaleiro founded and led a compounding pharmacy, catering to both human and veterinary patients in Cary, North Carolina. During his ownership of the pharmacy, he helped establish the Pharmacy Compounding Accreditation Board (PCAB) and served on various committees that developed industry standards. His pharmacy was among the first to receive PCAB accreditation. After selling the pharmacy, Mr. Cabaleiro joined PCAB during the organization’s most dynamic period of growth.

Mr. Cabaleiro received his Bachelor of Science in Pharmacy from the University of Florida. He has served as an adjunct professor at the University of North Carolina, and has written numerous articles in professional journals, as well as policy and procedure manuals for home-infusion and compounding pharmacies.


Editors

ADAM BEACH, PhD
Continuing Education Supervisor
 

Contributor

JOE CABALEIRO, BS Pharm, RPh
Senior Associate, Gates Healthcare Associates
Disclosure: Accreditation Commission for Health Care, Consultant; Gates Healthcare Associates, Consultant; Healthrx Group, Consultant; MEDISCA, Consultant

CPE Credits: 8.0 CPE hours = 0.8 CEUs
Joint Providership Status (CPE Consultants, LLC / LP3 Network)
Activity Type: Knowledge-based
UAN: 0864-9999-18-049-L03-P/T for Pharmacists and Pharmacy Technicians
Release Date: September 22, 2018.
Expiration date: September 22, 2021.

To receive CPE credits for the live component, participants must demonstrate full and satisfactory participation, and submit a completed evaluation.

accreditorCPE Consultants, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Accreditation Period

Course opens: 
01/20/2015
Course expires: 
12/31/2020

CANCELLATION AND REFUND POLICY:


A written request must be sent to LP3 Network requesting “Cancellation without Transfer” to an alternate live activity date. If cancellation occurs at greater than or equal to 31 days from the live activity date, then the registrant will receive a 75% refund; 15-30 days a 50% refund; and less than or equal to 14 days no refund.


TRANSFER POLICY:

The transfer policy is only in effect if requested greater than or equal to 14 days prior to the original live activity date. Failure to submit the “Transfer Request” at least 14 days prior to the original live activity date will default to the “Cancellation and Refund Policy”. The transfer policy can only be applied one (1) time. Transfer to a new live activity date must be within the current calendar year. Failure to attend the new live activity will result in no refund and will no longer be transferable. Confirmation of the new activity date is subject to approval by LP3 Network based on the number of available seats within the selected live activity. There are no refunds, returns, or transfers upon purchase of the home study.


 

Price

Cost:
$595.00
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