KPIC Advanced Sterile Compounding Training Program

Registration closes: May 4, 2015

Program Title: Advanced Sterile Compounding 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 Advanced Sterile Compounding Training Program is an intensive educational activity designed to equip pharmacists and technicians with immersive, hands on training in aseptic compounding operations. 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, validation, 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.

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

Department of Mental Health

Columbia,SC

Program Date: May 11-12, 2015

Instructors for this session are: Dr. Capps, Dr. Roberts, Carole Russell, Shay 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 homestudy 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 05/06/2015.

Program Agenda: see attached

Learning objectives: see attached

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

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/events.aspx?event_id=58 .

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 Advanced Sterile Compounding Training Program has been accredited for a total of 16.5 hours of live continuing education credit.

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 knowledge-based activity has been approved for 16.5 contact hours (1.65 CEUs) of live 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.

ACPE#: 0062-0000-14-133-L03-P/T (1 hour) Initial Release: 9/19/2014 Exp Date: 9/19/2017

ACPE#:0062-0000-14-134-L04-P/T (3 hours) Initial Release: 9/19/2014 Exp Date: 9/19/2017

ACPE#:0062-0000-14-135-L04-P/T (4.25 hours) Initial Release: 9/19/2014 Exp Date: 9/19/2017

ACPE#:0062-0000-14-136-L04-P/T (3.75 hours) Initial Release: 9/20/2014 Exp Date: 9/20/2017

ACPE#:0062-0000-14-157-L04-P/T (4.5 hours) Initial Release: 10/24/2014 Exp Date: 10/24/2017

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 26.5 hours 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/.

Date: May 11, 2015 08:00 AM - May 12, 2015 05:30 PM

Fee

$2,500.00

CE Hours

16.50

CE Units

1.650

Registration closes on May 04, 2015 11:00 PM

Activity Type

Knowledge

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

KPIC Advanced Sterile Compounding Training Program Agenda

Day 1:

Time	Session	Format
8:00 – 8:45	Welcome, Overview, Introduction Brutal Facts of Compounding	Lecture
8:45 – 9:00	Finger Tip Collection	Exercise
9:00 – 10:00	Review of USP <797>	Lecture
10:00 – 10:15	Break
10:15 – 12:15	Engineering Controls Primary Engineering Controls Secondary Engineering Controls Engineering Control Certification	Lecture
12:15 – 1:00	Lunch
1:00 – 3:00	Interactive Exercises (2 groups, rotating) GROUP 1: First Air and Aseptic Technique (everyone hands-on) Material handling: Particle generation and counts GROUP 2: Hand hygiene, garbing, gloved fingertip sampling	Lab
3:00 – 3:15	Break
3:15 – 4:15	Environmental Sampling: What, Why, Where & How	Lecture
4:15 – 5:15	Environmental Sampling Lab Develop & Execute sampling plan Collect surface and air samples Complete documentation and incubate plates	Lab
5:15 – 5:30	Summary and Observations

Day 2:

Time	Session	Format
8:00 – 8:15	Review of Day 1, Intro for Day 2	Lecture
8:15 – 9:00	Developing a Cleaning Plan	Lecture
9:00 – 9:45	Aseptic Media fills, process verification and developing an aseptic media fill test	Lecture
9:45 – 10:00	Break
10:00-10:45	Sterile to Sterile compounding, assigning BUDs and Quality release testing	Lecture
10:45 – 12:00	Nonsterile to sterile compounding, methods of sterilization and quality release testing	Lecture
12:00-12:45	Lunch
12:45 – 2:45	Interactive Exercises (2 groups) Bubble point testing Aseptic Media Fill Test Development Sterile Compounding Case Scenario Exercise	Lab/Exercises
2:45 – 3:00	Break
3:00 – 3:45	NIOSH Alert and Hazardous Drug Compounding	Lecture
3:45 – 4:30	Policy & Procedure Development	Lecture
4:30 – 5:15	Developing a Competency Program	Lecture
5:15 – 5:30	Q&A, Session Wrap up

Support/Credits

KPIC Advanced Sterile Compounding Training Program

Learning Objectives

Day 1: Morning Session

ACPE # 0062-0000-14-134-L04-P/T (3 credit hours)

ACPE# 0062-0000-14-133-L03-P/T (1 credit hour)

1. Overview and Brutal Facts of Compounding (.75 hour)

· Correlate the history of compounding mishaps with the evolution of compounding standards of practice and sterile compounding regulations.

· Recognize the regulatory compounding stakeholders and the present day regulatory conundrums.

2. Finger Tip Collection Exercise (.25 hour)

· Collect fingertip samples from unwashed hands for incubation.

· Validate the rationale for hand hygiene relative to sterile compounding.

3. Review of USP Chapter <797> Requirements (1 hour law)

· Summarize the scope and objectives of USP Chapter <797>.

· Examine the major elements of the chapter including: CSP microbial contamination risk levels, environmental quality and controls; personnel training and competency; as well as storage and beyond-use dating.

4. Engineering Controls (2 hours)

Part 1: Primary Engineering Controls

o Distinguish between primary and secondary engineering controls in the sterile compounding controlled environments.

o Utilize knowledge about the principles of airflow to compound with proper aseptic technique using first air regardless of the type of primary engineering control.

o Describe the function of HEPA filters in cleanroom environments and the application of airflow principles to create a sterile compounding environment

o Differentiate ISO Class 5, ISO Class 7 and ISO Class 8 work environments as related to cleanliness and particulate counts.

o Outline the different types of laminar airflow work centers (LAFWs) that may be utilized when preparing CSPs.

o Integrate an understanding of the term “state of control” into the certification report for primary and secondary engineering controls.

Part 2: Secondary Engineering Controls

o Explain the facility and environmental requirements for compounding sterile preparations for each of the three risk levels outlined in USP <797>.

o Differentiate the engineering controls used in the preparation of non-hazardous versus hazardous compounded sterile preparations.

o Summarize how the primary and secondary engineering controls work together to contribute to the overall sterile compounding facility state of control.

Part 3: Engineering Control Certification

o Integrate an understanding of the term “state of control” into the certification report for primary and secondary engineering controls.

o Identify and differentiate between the various tests performed during certification of primary and secondary engineering controls (HEPA filter leak test; particle counts, room segregation, airflow velocity and smoke pattern testing).

o Recognize the minimum engineering control requirements for sterile compounding controlled environments and how they contribute to attaining a state of control.

o Day 1: Afternoon Session {ACPE# 0062-0000-14-135-L04-P/T (4.25 credit hours)}

1. Interactive Exercises (2 hours total : 2 groups rotating)

Group I

o First Air and Aseptic Technique ( hands-on)

o Material handling: Particle generation and counts

Group 2:

o Hand Hygiene, Garbing and gloved fingertip sampling

LO’s for exercises:

· Visualize how first air (the clean air coming directly from the HEPA filter) can be affected by placement of materials in the direct compounding area.

· Identify proper aseptic manipulations performed in a manner that does not block first air.

· Correctly differentiate between horizontal and vertical primary engineering controls.

· Observe the particle generation that occurs under a variety of conditions and using a variety of supplies and identify material handling strategies to minimize impact of particles on CSPs.

· Identify impact of material transfer actions on particle counts when materials are moved into and out of PECS.

· Properly identify a direct compounding area (DCA).

· Successfully perform hand hygiene, garbing and GFS according to USP <797> requirements.

2. Environmental Sampling: What, Why, Where, When and How (1 hour)

• Explain the importance of Environmental Sampling.

• Discuss basic principles of microbiology as they relate to environmental monitoring.

• Discuss the elements of environmental and personnel sampling.

• Outline a model ongoing environmental monitoring program, including the identification of baseline and action limits of microbial growth detected during environmental monitoring processes.

3. Environmental Sampling Lab (1.0 hour)

o Develop and execute a sampling plan

o Collect surface and air samples

o Complete documentation of viable air and surface sampling.

5. Wrap-up/Q & A (0.25 hours)

Day 2: Morning Session {ACPE# 0062-0000-14-136-L04-P/T (3.75 credit hours)}

Review of Day 1 and Intro Day 2 (0.25)

1. Developing a Cleaning Program (.75 hour)

• Identify cleaning and material handling requirements outlined in USP <797>.

• Discuss principles related to the selection, preparation and use of cleaning agents and supplies.

• Sequence properly critical activities of daily and monthly cleaning.

• List personnel safety, training and competency considerations.

• Describe policy, procedure and documentation requirements.

2. Aseptic Media Fill and Process Verification (.75 hour)

· Summarize the importance of personnel and process media fill testing as verification of the aseptic technique skills of staff and compounding process.

· Describe documentation of operator and process media fill tests as well as required actions in the event that growth is detected.

· Compare the various types of media available for media fill test development

· Recognize if media-fill tests are designed to reflect compounding under challenging conditions

3. Sterile to Sterile Compounding: Assigning BUDs and Quality Release Testing (.75 hour)

· List the three non-high risk microbial contamination risk levels as well as their storage conditions.

· Discuss two factors that determine the beyond-use date (BUD).

· Differentiate the maximum BUDs for single-dose and multiple-dose containers as well as pharmacy bulk packaging.

· Describe quality release testing for non-high risk compounding.

4. Nonsterile to Sterile Compounding: Methods of Sterilization and Quality Release Testing (1.25 hour)

· Describe the conditions that require high risk level quality assurance procedures.

· Differentiate between the types of sterilization methods (sterilization by filtration, steam and dry heat sterilization as well as depyrogenation of equipment) as well as the evaluation of the effectiveness of each.

· Describe quality release testing of high risk level CSPs.

Day 2: Afternoon Session {ACPE# 0062-0000-14-157-L04-P/T (4.5 credit hours)}

1. Interactive Exercises (2 hours total ; 2 groups rotating)

Group 1:

Bubble Point Testing

Aseptic Media Fill Test Development

Group 2:

Sterile Compounding Case Scenario Exercise

LO’s for exercises:

· Correctly perform filter integrity testing using the bubble point test

· Using case study scenarios, develop a process for quality release testing and assigning beyond use dating

2. NIOSH Alert and Hazardous Drug (HD) Compounding (.75 hour)

· Summarize the guidelines and recommendations contained in the NIOSH Alert 2004-165.

· List specific aseptic techniques used to improve safety during handling and compounding of HDs.

3. Policy and Procedure Development (.75 hour)

· Summarize how policies, procedures and documentation are critical to USP <797> compliance.

· Evaluate the policy and procedure template and the environmental sampling policies and forms provided.

· Describe the desired elements of a PnP system including change control.

4. Developing a Competency Program (.75 hour)

· Differentiate between competency and proficiency.

· Cite the 3 competency assessments required by USP Chapter <797> as well as a variety of other competency/proficiency opportunities.

· Consider higher level competency/proficiency approaches that generate additional value for your organization beyond documentation of competency.

5. Wrap-up/Q&A (.25 hr)

Total 16.5 hours live including 1 hour of Law

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

Registration closes: May 4, 2015

Mon, May 11, 2015

Registration closes on May 04, 2015 at 11:00 PM