Sterile Compounding: Management and Practical Compliance with USP <797> Training Program

Target Audience: This course is targeted for Pharmacists and Pharmacy Technicians responsible for managing, developing, implementing or regulating sterile compounding operations.

Statement of Need: Sterile compounding is an important part of patient and pharmaceutical care in the US healthcare system. A 2007 research article published in the American Journal of Health-system Pharmacy reported that sterile compounding training varied widely in US pharmacy schools and that only 13% of Deans felt graduates had adequate training in this area of practice. Some pharmacy technicians may also play a vital role in this area of pharmacy practice and training programs for these individuals varies widely as well. In recent times, FDA 483 reports have indicated numerous cases of sterile compounding facilities that were deficient in topic areas covered in this course. Maintaining a controlled sterile compounding environment is paramount to assuring safe and properly prepared sterile drug products. The course will provide practical experience and resources that will assist participants to critically evaluate existing sterile compounding practice and make modifications necessary to ensure compliance with USP guidelines for low, medium, and some high risk sterile compounding.

Program Description: The KPIC Sterile Compounding: Management and Practical Compliance with USP <797> Training Program is an intensive educational activity designed to equip pharmacists and technicians with immersive, hands on training provided in a practice-based format that allows for implementation into the participant’s sterile compounding practice setting. This program is targeted to individuals who will be serving in a management or regulatory role for sterile compounding operations. Participants are expected to have pre-requisite knowledge and experience with basic aseptic technique principles prior to participating in this course. In the live training, learners are presented information to assist them to implement cleanroom principles and practices that comply with USP <797> as well as industry best practices. Classes are taught in a state-of-the-art facility designed for cleanroom and pharmacy practice demonstration. Topics covered include engineering controls and airflow science; personnel media fill testing and process validation as well as an exploration of principles associated with workflow, cleaning, environmental sampling, staff training and documentation. Attendees completing this program will gain an understanding of how to develop and implement an operation that meets or exceeds USP Chapter <797> requirements. Participants will take home sample electronic templates for policies, procedures and documentation that can be customized to their facility’s needs.

As a pre-requisite to the live activity, the participant must first complete a home study component. The home study includes 10- one hour modules that will prepare the student for the intensive hands-on training. The home study is offered through Critical Point and is included in the cost of the program. The participant must complete all modules, complete the interactive exercises and successfully pass the competency assessments for each module to claim credit for the home study.

Goals will include:

Effectively utilize cleanroom/hood certification reports to identify if a cleanroom is within a "state of control"
Effectively develop and implement an environmental sampling plan
Understand proper cleaning of the cleanroom environment
Perform personnel competency assessment as outlined in USP <797>
Effectively utilize tools to evaluate insourcing versus outsourcing when drug shortages arise.

Participant Requirements: To receive continuing education credit for this program, participant must be a registered pharmacist or pharmacy technician. Participant must physically be able to stand for a minimum of 2 hour periods and must have manual dexterity to allow manipulation of needles, syringes and other products utilized to prepare sterile products. Participant must also have full range of motion to complete physical tasks required in the compounding processes.

Program Faculty:

Nancy Roberts , PharmD, MS

Patient Care Pharmacist

West Georgia Medical Center

LaGrange, Georgia

Carole Russell RPh; BS, MHSA

Compounding Pharmacist

Medical University of South Carolina

Charleston, SC

Shay Garrison, RPh; BS, MPH

Pharmacy Manager

Palmetto Health Richland Hospital

Richard Capps, PharmD

Pharmacy Manager

Greenville Memorial Hospital

Chase Parks, PharmD

Pharmacist

Co-Owner/Pharmacist-in-Charge

Skrip Shoppe Compounding Pharmacy

Greer ,SC

Program Date: May 23-24, 2016

Instructors for this session are: Dr. Capps, Dr. Roberts, Mrs.Russell, Mr. Garrison, and Dr. Parks.

Registration: Registration will be completed online at http://SCCP.learningexpressce.com. Once registered, attendees will be provided with access to CriticalPoint’s eLearning Management System in order to access and complete the home-study portion of the program. The self-study component must be successfully completed prior to the live program. Cut-off for completion of self-study will be no later than 11:59pm on 05/18/2016.

Location of event: The training program will be offered at the Aseptic Compounding Experience (ACE) Lab, located at 715 Sumter Street, South Carolina College of Pharmacy -University of South Carolina campus in Columbia, SC.

Registration fee:

$2500 (standard), $2250 (early registration) Early registration must be completed at least 30 days prior to event. Early Registration ends April 24, 2016. After April 24, 2016, registration becomes $2500.00.

Registration is limited and will be taken on a first come first serve basis. Fee includes required self-study materials, on-site training, and continuing education credit. For the two-day live training program; breakfast, lunch, and morning and afternoon snacks are provided. Registrants are responsible for dinner, any travel expenses, and hotel accommodations. Hotel and parking recommendations are available at http://www.kennedycenter.sc.edu/innovationsterilecompounding.aspx .

Program Cancellation and Refund Policy:

Cancellation Policy: Cancellations received in writing at least 30 days prior to program date via letter or email to ce@sccp.sc.edu will receive a full refund minus a $350 cancellation fee.

We reserve the right to cancel the entire program. In the event of a conference cancellation, each participant will be notified via phone and/or email at least 14 days prior to the program and a full tuition refund will be made.

In the event of inclement weather, the decision to cancel a course will be made no later than 9:00 am Eastern time the day before the program.

Registration transfers
Individuals attending the course in place of the registered individual will be honored as long as the request is made in advance of the registration deadline, which is 14 days prior to the start of the live component. Transfer participants must still complete the required prerequisite self-study at least 48 hours in advance of the live training.

Refunds
Refund requests are subject to a $350.00 cancellation fee and must be received 30 days prior to the start of the live component. All registration cancellations must be submitted in writing or by e-mail to the Continuing Education Department at the following address.

South Carolina College of Pharmacy – USC Campus
Continuing Education

715 Sumter Street, Room 318

Columbia, SC 29208

Email: ce@SCCP.sc.edu

Registrants may receive 100% of the program registration fees, less the $350.00 cancellation fee up to 30 days prior to start date of the live component. No refunds are offered for cancellations fewer than 30 days prior to the start date of the live component or for no shows.

RSVP Information and cut-off date: Registration will be accepted until 14 days prior to the start of the live practice based component or until capacity has been reached.

There is no commercial support for this program.

ACCREDITATION INFORMATION:

The South Carolina College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The KPIC Sterile Compounding: Management and Practical Compliance with USP <797> Training Program has been accredited for a total of 16hours of live continuing education credit. 1 hour of this program is a knowledge based activity reviewing the regulatory issues relevant to sterile compounding practice (ACPE# 0062-9999-16-069-L03-P/T). The practice based activity is accredited for 15 hours for both pharmacists and pharmacy technicians (ACPE#0062-9999-16-070-L04-P/T). Both activities are required to complete the program.

The pre-requisite home study activity must be completed prior to attending the live program. In order to receive continuing education credit for the self-study activities, the participant will be required to complete 10 eLearning modules provided through Critical Point and successfully complete the learning exercises and post-tests assigned to each module. This knowledge based activity has been approved for 10 hours of home study continuing education credit. (ACPE#: 0761-9999-13-248 through 255-H04-P/T) Initial Release Date: 8/1/2013; Expiration Date: 7/31/2016.

For successful completion for the live activity, participants will be required to attend the accredited program in its entirety, successfully demonstrate competencies using planned simulations, and complete speaker and program evaluations. This live activity has been approved for 16 contact hours (1.6 CEUs) of continuing education credit including one hour of law. Credit claimed will be automatically uploaded to CPE Monitor. Each participant is required to provide their NABP ePID and month and day of birth; CPE credit will not be issued to individuals that do not provide this information.

Note: On successful completion of both the home study pre-requisite from Critical Point and the live activity from SCCP, the participant will have earned a total of 26hours of continuing education credit. For participants that complete the entire program, Certificates of Completion will be provided.

Contact Information: If you have questions about this CPE activity, please contact the CE office at 803-777-9979 or ce@sccp.sc.edu

Disclosure Statements:

Faculty Disclosures: Faculty reports no financial or personal relationship with any commercial interest producing, marketing, reselling, or distributing a product or service that appears in this presentation.

Activity Staff Disclosures: The planners, reviewers, staff and CME committee who control content have no relevant financial relationships to disclose.

Activity Requirement: Internet connectivity and Adobe Acrobat Reader are required for participation in this activity.

REQUIRED COMPUTER HARDWARE/SOFTWARE:

Please ensure the computer system you plan to use meets the following minimum requirements:

· Operating System: Windows XP SP2 or later, Windows Vista, Windows 7, Mac OS X 10.5 or later

· Internet Browser (Mac &/ Windows): Internet Explorer 7 or later, Firefox 3.5 or later, Safari 4

· Broadband Internet connection: Cable, High-speed DSL & any other medium that is internet accessible

· Peripherals: Computer speakers or headphones

· Monitor Screen Resolution: 320 x 480 or higher

· Media Viewing Requirements: For some components, the most up-to-date version of Adobe Flash may be required. To obtain the free Flash plug-in, go to http://get.adobe.com/flashplayer/.

KPIC Sterile Compounding: Management and Practical Compliance with USP <797> Training Program Learning Objectives:

1. Review of Sterile Compounding Regulation (1 hour, Law)

At the conclusion of this activity, the participant will be able to:

Correlate compounding mishaps with the evolution of sterile compounding regulation.
Discuss the legal and regulatory players in the sterile compounding industry.
Discuss the policy and procedure gap analysis process.

2. Practice Based Activity Day 1: (7 hours):

At the conclusion of this activity, the participant will be able to:

Summarize how the primary and secondary engineering controls work together to contribute to the overall sterile compounding facility state of control.
Analyze a certification report to identify key components and how to effectively utilize the information to maintain a “state of control” within the cleanroom environment.
Design and implement an environmental sampling plan.
Analyze material handling and personnel processes in a cleanroom in order to minimize particle generation and risk of contamination to the cleanroom environment and sterile compounds.
Develop and implement a cleaning program that complies with USP <797> requirements.
Analyze environmental sampling results to identify potential issues related to cleaning activities.

Day 2: (8 hours)

Describe and document the required personnel competencies outlined in USP <797>.
Evaluate personnel performing hand hygiene, garbing, and gloved fingertip sampling according to USP <797> requirements.
Develop a media fill competency appropriate for various compounding risk levels.
Discuss the use of automation in the sterile compounding process.
Develop a process for quality release testing, batch testing, and assigning a beyond use date for sterile compounds.
Evaluate the challenges of managing drug shortages and apply available tools to determine the appropriate use of outsourcing facilities versus insourcing for sterile compounding.
Discuss the key highlights of USP <800> related to containment, personal protective equipment (PPE), and cleaning/decontamination.
Identify the components of and implement a hazard communication plan.

Home study (provided through CriticalPoint) = 10 hours (Each module is 1 credit hour)

0761-9999-13-255-H04-P/T Batch Documentation and CSPs

0761-9999-13-250-H04-P/T Determining Beyond-Use Dating

0761-9999-13-257-H04-P/T Documentation

0761-9999-13-254-H04-P/T Labeling and Packaging

0761-9999-13-249-H04-P/T Overview of Quality and Responsibilities of Compounding Personnel

0761-9999-13-252-H04-P/T Proper Material Handling

0761-9999-13-256-H04-P/T Purpose and Effective Use of Policies and Procedures

0761-9999-13-253-H04-P/T Quality Releases and Final Check of CSPs

0761-9999-13-248-H04-P/T The History of Compounding and USP 797

0761-9999-13-251-Ho4-P/T Use of Syringes, Needles, Vials, Ampules and Filters

Outline of Activity

Day 1:

Time	Session	Format
8:00 – 9:00	Welcome, Overview, Intro, Review of Regulatory Issues	Lecture
9:00-10:30	Engineering Controls Primary Engineering Controls Secondary Engineering Controls	Lecture
10:30 – 10:45	Break
10:45-11:15	Engineering Controls – cont’d Engineering Control Certification	Lecture
11:15 – 12:15	Environmental Sampling	Lecture
12:15 – 1:15	Lunch
1:15-3:15	Interactive Exercises Lab tour – SCA/CAI, SECs, PECS First Air – Smoke test Particle generation and counts Hood certifier report examples – how to interpret Surface sampling and air sampling Environmental sampling results – how to interpret Corrective action plans	Lab
3:15-3:30	Break
3:30-4:15	Developing a Cleaning Plan	Lecture
4:15-5:15	Cleaning demo, documentation, and corrective action plans	Lab
5:15-5:30	Wrap-up – summary, observations

Day 2:

Time	Session	Format
8:00 – 8:15	Review of Day 1, Intro for Day 2	Lecture
8:15 – 9:00	Personnel Competencies (HH, PPE, GFS, MF)	Lecture
9:00 – 10:00	Developing Competency Plan – demo, PPE, personal assessment, documentation tools, Media Fill kits (PART 1)	Lab
10:00-10:15	Break
10:15-11:15	Developing Competency Plan – demo, PPE, personal assessment, documentation tools, Media Fill kits (PART 2)	Lab
11:15-12:15	Sterile to Sterile compounding, BUD determination, Quality release testing and automation	Lecture
12:15-1:15pm	Lunch
1:15-2:15pm	Nonsterile to sterile compounding, stability vs sterility testing, BUD determination, methods of sterilization and quality release testing	Lecture
2:15-3:15pm	Interactive Exercises (Part 1) Filter sterilization exercise Bubble point testing Millipore phone app - demo Batch testing/Sterile Compounding Case Scenario Insourcing/Outsourcing Managing drug shortages	Lab/ Exercises
3:15-3:30pm	Break
3:30 – 4:30pm	Interactive Exercises (Part 2) Filter sterilization exercise Bubble point testing Millipore phone app - demo Batch testing/Sterile Compounding Case Scenario Insourcing/Outsourcing Managing drug shortages	Lab/ Exercises
4:30-5:15	Overview/highlights of 800 – NIOSH alert, HCP, containment	Lecture
5:15 -5:30	Q&A, Session Wrap up

Date: May 23, 2016 08:00 AM - May 24, 2016 05:30 PM

Fee

$2,500.00

CE Hours

16.00

CE Units

1.600

Registration closes on May 08, 2016 11:55 PM

Activity Type

Certificate-Based

Target Audience(s)

Pharmacists
Pharmacy Technicians

Accreditation(s)

The University of South Carolina College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Requirements for CE Credit

Participants must check in with the front desk upon arrival and have attendance verified.

For successful completion for the live activity, participants will be required to attend the accredited program in its entirety, successfully demonstrate competencies using planned simulations, and complete speaker and program evaluations. Credit claimed will be automatically uploaded to CPE Monitor. Each participant is required to provide their NABP ePID and month and day of birth; CPE credit will not be issued to individuals that do not provide this information. .

Mon, May 23, 2016

Registration closes on May 08, 2016 at 11:55 PM

KPIC Management and Practice Compliance with USP<797>:A Regulatory Review

Registration Closed

At the completion of this activity, the participant will be able to:
1. Correlate compounding mishaps with the evolution of sterile compounding regulation.
2. Discuss the legal and regulatory players in the sterile compounding industry.
3. Discuss the policy and procedure gap analysis process

Speaker(s)/Author(s)

Nancy Roberts, PharmD, MS
Sterile Compounding Training, Program Director, KPIC, University of South Carolina

Activity Number

0062-9999-16-069-L03-P/T

Date: 05/23/16

Time: 08:00 AM - 09:00 AM

CE Hours

1.00

Registration Closed

Tue, May 24, 2016

Registration closes on May 08, 2016 at 11:55 PM

KPIC Sterile Compounding: Management and Practical Compliance with USP <797>

Registration Closed

At the completion of this activity, the participant will be able to:
Day 1:
• Summarize how the primary and secondary engineering controls work together to contribute to the overall sterile compounding facility state of control.
• Analyze a certification report to identify key components and how to effectively utilize the information to maintain a “state of control” within the cleanroom environment.
• Design and implement an environmental sampling plan.
• Analyze material handling and personnel processes in a cleanroom in order to minimize particle generation and risk of contamination to the cleanroom environment and sterile compounds.
• Develop and implement a cleaning program that complies with USP <797> requirements.
• Analyze environmental sampling results to identify potential issues related to cleaning activities.
Day 2:
• Describe and document the required personnel competencies outlined in USP <797>.
• Evaluate personnel performing hand hygiene, garbing, and gloved fingertip sampling according to USP <797> requirements.
• Develop a media fill competency appropriate for various compounding risk levels.
• Discuss the use of automation in the sterile compounding process.
• Develop a process for quality release testing, batch testing, and assigning a beyond use date for sterile compounds.
• Evaluate the challenges of managing drug shortages and apply available tools to determine the appropriate use of outsourcing facilities versus insourcing for sterile compounding.
• Discuss the key highlights of USP <800> related to containment, personal protective equipment (PPE), and cleaning/decontamination.
• Identify the components of and implement a hazard communication plan.

Speaker(s)/Author(s)

Carole Small Russell, RPh, MHSA Compounding Pharmacist, MUSC
Kenneth Chase Parks Pharmacist, Department of Mental Health
Nancy Roberts, PharmD, MS Sterile Compounding Training, Program Director, KPIC, University of South Carolina
Richard Capps, PharmD Pharmacy Manager, Prisma Health Oconee Memorial Hospital
Shay Garrison, RPh, MPH Pharmacist Specialist, Prisma Health Richland

Activity Number

0062-9999-16-070-L04-P/T

Date: 05/24/16

Time: 08:00 AM - 05:30 PM

CE Hours

15.00

Registration Closed

Sterile Compounding: Management and Practical Compliance with USP <797> Training Program

Fee

CE Hours

CE Units

Activity Type

Target Audience(s)

Accreditation(s)

Requirements for CE Credit