Preparing for a State Board of Pharmacy Compounding Practice Inspection

A University of Florida College of Pharmacy accredited Applicaton-based Activity


Registration and Contact Information:

For more information and to register for this activity

Call 1-844-408-9453 or visit  https://education.lp3network.com/live-training/state-board-pharmacy-compounding-practice-inspection 


Activity Description

The Application-Based Live Event Activity will provide compounding pharmacists and technicians the tools to develop the necessary competence to prepare for, maintain, or acquire licensure for a compounding practice with respect to a State Board of Pharmacy inspection. Unique concepts will be taught, and practice tools provided, to facilitate inspection readiness behaviors and skills that pharmacists and technicians can apply in their day-to-day practice. There will be in-depth assessment and evaluation of relevant legal documents, regulations, and standards of practice currently guiding the compounding industry. Participants of the Live Event Activity will learn how to evaluate Standard Operating Procedures and their readiness for an inspection; their completeness, compliance with standards, and correlation with data recording requirements will be under investigation. Self-directed inspection techniques will be developed through the use of realistic data recordings during data reviewing activities; this in consideration of good documenting practices. Once data recordings are assessed for discrepancies and trends, if required, there will be an appropriate determination of Corrective Action and Preventive Action (CAPA).

Quality, risk, and verification management are fundamental cornerstones of a successful compounding practice and readiness for inspection. Participants will be afforded the opportunity to assess compounding practice behaviors through these three perspective views. Moreover, quality, risk, and verification requirements will be applied to personnel management, property management, general procedures, process development, finished preparations, and patient monitoring and outcome measures.

During the Live Event Activity, pharmacists and technicians will be given the opportunity to complete an inspection readiness profile as they establish self-directed action plans to improve their inspection readiness in their own compounding pharmacy practice.

Activity Offerings

The following 2016 dates represent activities offered for this activity:

January 23rd in Los Angeles, California
May 21st in Boston, Massachusetts
August 13th in Las Vegas, Nevada
October 29th in Aventura, Florida

Intended Audience

Pharmacists and Technicians

Activity Design

A two day live event with competency assessment.

Learning Objectives – Pharmacist 

  • Identify compounding practice parameters under current regulatory jurisdiction. (P)
  • Identify relevant regulations and standards of practice in the compounding industry. (P)
  • Identify licensing and licensure requirements within one’s own state and for interstate commerce. (P)
  • Review standard operating procedures for their compliance with current standards of practice. (P)
  • Apply quality, risk, and verification management systems to assist in preparation for an inspection. (P)
  • Review realistic recorded data sets for compliance with their corresponding standard operating procedures. (P)
  • Analyze data patterns and trends within and between records in the manner of logs and forms. (P)
  • Analyze and demonstrate traceability between various compounding practice parameters during times of recall. (P)
  • Learn to initiate corrective and preventive measures where appropriate in a compounding practice. (P)
  • Relate inspection preparation tools to current good compounding practice parameters. (P)
  • Analyze the strengths and weaknesses, and overall inspection readiness, for a compounding practice. (P)

Learning Objectives – Pharmacy Technician  

  • Identify compounding practice parameters under current regulatory jurisdiction. (T)
  • Identify relevant regulations and standards of practice in the compounding industry. (T)
  • Identify licensing and licensure requirements within one’s own state and for interstate commerce. (T)
  • Review standard operating procedures for their compliance with current standards of practice. (T)
  • Apply quality, risk, and verification management systems to assist in preparation for an inspection. (T)
  • Review realistic recorded data sets for compliance with their corresponding standard operating procedures. (T)
  • Analyze data patterns and trends within and between records in the manner of logs and forms. (T)
  • Analyze and demonstrate traceability between various compounding practice parameters during times of recall. (T)
  • Learn to initiate corrective and preventive measures where appropriate in a compounding practice. (T)
  • Relate inspection preparation tools to current good compounding practice parameters. (T)
  • Analyze the strengths and weaknesses, and overall inspection readiness, for a compounding practice. (T)

Activity Editors:

Daphnee Lalonde, MSc
Program Coordinator, LP3 Network Inc.
Disclosure: LP3 Network Inc., Learning Management and Logistics

Neil Cohen, BSc
Program Coordinator, LP3 Network Inc.
Disclosure: LP3 Network Inc., Director of Technical Operations

Juliana Korah, PhD
Scientific Editor, LP3 Network Inc.
Disclosure: LP3 Network Inc., Medical Editor/Continuing Education Coordinator,

Activity Contributors:

Christine Roussel, PharmD, BCOP
Clinical Pharmacy Manager, Doylestown Hospital
Disclosure: LP3 Network Inc.

Mark Filosi, BSc, RPh
Pharmacist/Owner, Family Care Pharmacy
Disclosure: LP3 Network Inc.

Brad Steeves, BSc, BSc Pharm
Pharmacist/Owner, Mapleton Guardian Pharmacy
Disclosure: LP3 Network Inc.

Sandra Telesmanic, BSc, RPh
Clinical Pharmacist and Consultant
Disclosure: LP3 Network Inc.

Activity Facilitators:

Joe Cabaleiro, RPh

Joe 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 Director of Standards Interpretation and 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 and continues to serve as a consultant to the ACHC.

Participant Completion Requirements

To receive CPE credits for the Live Program, participants must demonstrate full and satisfactory participation, and submit a completed evaluation to the University of Florida College of Pharmacy.

Participants registered in the United States: The University of Florida College of Pharmacy will report CPE credits to the CPE Monitor. A paper copy of a statement of credit may be obtained from your NABP e-profile. For participants registered in the state of Florida, UFCOP will report credits to CE Broker.

Participants registered other than in the United States: Participants will receive a statement of credit by mail.

Declarations and Disclosures

The University of Florida College of Pharmacy believes it is important for the reader to be aware of relevant affiliations and financial relationships regarding the development, design and facilitation of this activity and its financial supporter and the financial supporter’s affiliates.

This activity has been approved by, and is hosted by, the University of Florida College of Pharmacy and is independent of any known bias, prejudice or commercial interest. The University of Florida College of Pharmacy has requested that LP3 Network Inc. assist with the marketing of this activity. LP3 Network Inc. is an independent corporation. LP3 Network Inc. has an established agreement with MEDISCA Inc. ensuring that it has no influence on LP3 Network Inc. as it relates to activity offerings.

Accreditation

This activity is accredited by the University of Florida College of Pharmacy in accordance with ACPE Standards for Quality and Interpretive Guidelines. The University of Florida College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as providers of continuing pharmacy education. The University of Florida College of Pharmacy has allocated 8 hours of continuing education credit (.8 CEUs) to this application based activity. The UANs are  0012-0000-15-016-L03-P (Pharmacists) and 0012-0000-15-016-L03-T (Pharmacy Technician). Release dates: 1/20/15-1/20/2018.

Financial Support

An unrestricted educational grant has been provided by MEDISCA Inc. toward the purchase of electromechanical equipment, reusable and disposable devices, protective and safety supplies, and chemicals specific to compounded medications prepared during laboratory sessions.

Food and Beverage

As a matter of activity programming, meals and refreshments during live activities have been provided by LP3 Network Inc.

Cancellation and Refund Policy

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

Transfer Policy

The transfer policy is only in effect if requested greater than or equal to 14 days prior to original live activity event date. Failure to submit the “Transfer Request” at least 14 days prior to original live activity event 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 event date must be within the current calendar year. Failure to attend the new live activity event will result in no refund and will no longer be transferable. Confirmation of the new activity date is subject to approval by LP3 Network Inc. based on the number of available seats within the selected live activity event.

Hotel Accommodations

Special rates for hotel accommodations have been arranged for activity participants. Payment for hotel accommodations is at the expense of the activity participant.


ACPE LogoThe University of Florida College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.