2023 USP <797> Sterile Compounding and Aseptic Processing Training Program and USP <800> Training for Proper Handling of Hazardous Drugs

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LIVEACPEN_ACPE

Tuesday, October 3, 2023, 8:00 AM - Thursday, October 5, 2023, 5:00 PM EST, VCU Smith Pharmacy Building, Richmond, VA

USP <797> Sterile Compounding & Aseptic Processing
October 3-4, 2023
Registration fee:  $795

This certificate program for pharmacists and pharmacy technicians is a comprehensive practice based educational activity designed to provide didactic and hands-on training allowing the participants to develop knowledge and skills necessary to compound sterile preparations safely and effectively.

Participants will be taught processes and skills required of all sterile product compounders based on current regulations and using situations most likely to be experienced in a sterile compounding environment.  

Participants must successfully demonstrate competency via hands-on simulation using current technology in a state-of-the-art sterile compounding facility. Immediate feedback is provided by the course directors. 

USP <800> Training for Proper Handling of Hazardous Drugs
October 5, 2023
Registration fee:  $495

Hazardous drugs (HDs) require safe and responsible handling for you and your team, whether medical, nursing, or pharmacy.  USP <800> standards provide oversight guidance on best practices for compounding HDs.  This program reviews current and proposed regulations and recommends best practices concerning all aspects of handling HDs.

This one-day workshop will include:

• understanding quality systems, process flow and risk assessment;
• preparing for inspection readiness, and;
• provide practical application including hands-on skills development and implementation of best practices when compounding sterile and nonsterile HDs.
  

1. Illustrate the chronological evolution of pharmacy compounding up to present day USP General Chapter <797>
2. Compare the roles of USP and FDA with regard to standards and enforcement.
3. Apply relevant regulatory guidelines associated with pharmacy sterile compounding.
4. Illustrate the typical layout of a cleanroom including primary and secondary engineering controls.
5. Discuss the role of the pharmacist and pharmacy technicians’ responsibilities pertaining to sterile compounding.
6. Demonstrate cleaning and disinfection of pharmacy controlled environments.
7. Demonstrate proper personnel hand hygiene, garbing, gloved fingertip sampling and media fill tests.
8. Compile the similarities and differences between sterile preparations with the various risk levels.
9. Discuss the importance of appropriate beyond use dating principles.
10. Illustrate the chronological evolution of pharmacy compounding up to present day USP Chapter <800>.
11. Provide an overview of USP Chapter <800> for hazardous drug compounding.
12. Classify hazardous drugs along with risk assessment and approaches for exposure control.
13. Identify potential challenges with USP Chapter 800 facility design requirements - primary engineering controls and secondary engineering controls - and strategies to address them.
14. Discuss regulatory implications and considerations for operating a 503A Traditional Compounding Pharmacy vs. a 503B Outsourcing Facility.
15. Describe compounding pharmacy scenarios that demonstrate the steps needed to achieve regulatory compliance with current hazardous drug handling standards.
16. Discuss personnel training and competency assessment, personal protective equipment, proper donning and doffing of PPE for compounding hazardous drugs..
17. Discuss best practices for minimizing exposure to hazardous drugs-labeling, packaging, transport, dispensing, spill management, disposal, administering-to prevent occupational exposure to hazardous drugs
18. Describe proper procedures for deactivating, decontaminating, cleaning and disinfecting primary engineering controls and secondary engineering controls used for compounding hazardous drugs.

Registration is now closed.

In support of improving patient care, VCU Health Continuing Education is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Sterile Compounding and Aseptic Processing Training Program
This activity provides 16 contact hours (.16 CEUs) of continuing education credit. ACPE Universal Activity Number (UAN): JA4008237-0000-23-009-L07-P & JA4008237-0000-23-009-L07-T

USP <800> Compliant Handling of Hazardous Drugs
This activity provides 8 contact hours (.8 CEUs) of continuing education credit. ACPE Universal Activity Number (UAN): JA4008237-0000-23-008-L07-P & JA4008237-0000-23-008-L07-T

 NOTE FOR PHARMACISTS: VCU Health Continuing Education will upload the pharmacy-related continuing education information to CPE Monitor within 60 days of activity completion. Per ACPE rules, VCU Health Continuing Education does not have access nor the ability to upload credits requested more than 60 days after activity completion. It is the responsibility of the pharmacist or pharmacy technician to provide the correct information [NABP ePID and DOB (in MMDD format)] in order to receive credit for participating in a continuing education activity.

Accommodation
All participants have the right to participate in this continuing education activity without discrimination due to age, race, ethnicity, religion, culture, language, physical or mental disability, socioeconomic status, sex (sexual orientation, gender identity or expression and pregnancy), protected veteran status, marital status, genetic information, or any other protected characteristics under applicable federal, state, or local law. If you need accommodations to participate in this activity, please contact us at [email protected] for more information. Requests for accommodations must be received 21 days prior to activity start date.

Complaint Policy and Resolution Process
All complaints must be made in writing to [email protected].

All complaints will be logged into the complaint log. The Director, Continuing Education will attempt to resolve the complaint within the first contact, when possible, and will respond to the client and customer's concerns within 5 business days of the initial complaint. At the time of the first contact, Director, Continuing Education will inform the complainant if more time will be needed to research the complaint.

If the complaint is still unresolved after communication with the Director, Continuing Education, or if the initial complaint is not addressed in a timely manner, the complainant may contact the President & CEO, UHS-PEP. The President & CEO will then contact the complainant and endeavor to resolve the complaint within 10 business days after being contacted.

The complaint log will be regularly reviewed to identify areas of operations and service that may require improvement. The Director, Continuing Education will research reoccurring complaint matters and recommend process and procedure changes, when appropriate. These changes will be noted on the Complaint Resolution Log, and any necessary policy and/or procedure updates will be made within 15 business days thereafter.

Disclaimers
Minimum and maximum numbers for attendance at this event have been established, and we reserve the right to substitute speakers/topics, adjust credit hours, or cancel if necessary.

By attending this event you grant VCU Health Continuing Education the right at the event to record, film, photograph, or capture your likeness in any media and to distribute, broadcast, use, or otherwise disseminate, in perpetuity, such media without any further approval from or any payment to you. 

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

ACPE - Accreditation Council for Pharmacy Education (24.00 hours), Participation - Ineligible for ACPE credit (24.00 hours)

The Richmond Marriott offers a special rate for guests affiliated with VCU; please call the hotel at 804-643-3400 and request a reservation at the VCU rate. Parking fees are additional.

Other area hotels also offer special rates for VCU-affiliated guests. Please inquire when making your reservation.

Mitigation of Relevant Financial Relationships

VCU Health Continuing Education adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a continuing education activity, including faculty, planners, reviewers or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.

There is no commercial or in-kind support for this activity.