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ForwardMEDISCA Australia | Achieving Best Practices: Sterile Compounding 2-4 June 2023
Achieving Best Practices: Sterile Compounding
COURSE TIMETABLE
Friday 2 June: 11:00AM - 5:00PM
Saturday 3 June: 8:00AM - 5:00PM
Sunday 4 June: 8:00AM - 5:00PM
This course includes a home study component that serves as a prerequisite to the live activity. Activity participants are required to achieve a 75% passing grade associated with a self-study learning assessment prior to attending the live event. Full attendance and the completion of an activity evaluation and practical skill set competency evaluation are a compulsory requirement to receive a certificate for the activity.
ACTIVITY DESCRIPTION
The Practice-based Activity will provide the pharmacist and technician with current theoretical knowledge, practical skill and measurable competencies necessary to meet the high standard of practice required for a sterile compounding practice and the autonomy to make informed decisions as they relate to a broad range of performance measures. The activity is comprised of an interactive self-study workbook and a highly dynamic live event staged in a sterile compounding facility. Pharmacists and technicians will be afforded the opportunity to prepare compounded sterile preparations in an ISO class 5 environment. Further, pharmacists and technicians will learn how to conduct all necessary maintenance, control, monitoring and testing procedures to sustain a sterile compounding facility and prepare compounded sterile preparations as they ensure high quality, assess elements of risk and learn how to validate all aspects of sterile compounding practice.
The Practice-based Activity features a series of 16 workstations, each one-hour in duration, and includes four (4) compounded sterile preparations, four (4) simulated sterile preparations, a robust Media-Fill Challenge test, Master Formulation Record design, facility workflow design, risk management assessment development, validation protocol development, observational auditing, automated compounding device training, and a hands-on session related to a series of technologies used in environmental monitoring, measuring, preparation testing, sterilization, sanitization, incubation and validation.
Intended audience
Pharmacists and Technicians new to sterile compounding or with an existing compounding practice.
ACTIVITY DESIGN
A two part activity; self-study with learning assessment and live event with competency assessment.
Learning Objectives
Objectives - Pharmacist
After completing this module, the pharmacist will be able to:
- Demonstrate donning and doffing, hand hygiene, aseptic manipulations and sanitization techniques
- Demonstrate the use of closed system transfer devices for hazardous drug compounding
- Prepare compounded sterile preparations in an ISO classified three-room cleanroom suite
- Assess and perform adjustment calculations for drug form and certificate of analysis-related indications
- Assess and perform overage calculations for processing, sterility and endotoxin testing
- Sketch a cleanroom suite for optimal workflow
- Create a Master Formulation Record
- Explain how to perform the gloved fingertip and thumb sampling and a media-fill test
- Summarise findings of a risk assessment, and then construct a corrective action and preventive action plan
- Summarise findings following an inspection, and then construct a corrective action and preventive action plan
- Operate electromechanical equipment (e.g., balance, automated compounded devise, particulate samplers (non-viable and viable), incubator, sterilizers (steam and dry heat), biological indicator and chemical integrator, pH meter, and more)
Objectives - Technician
After completing this module, the pharmacy technician will be able to:
- Demonstrate donning and doffing, hand hygiene, aseptic manipulations and sanitization techniques
- Demonstrate the use of closed system transfer devices for hazardous drug compounding
- Prepare compounded sterile preparations in an ISO classified three-room cleanroom suite
- Solve adjustment calculations for drug form and certificate of analysis-related indications
- Solve overage calculations for processing, sterility and endotoxin testing
- Sketch a cleanroom suite for optimal workflow
- Complete a Master Formulation Record
- Explain how to perform the gloved fingertip and thumb sampling and a media-fill test
- Describe findings of a risk assessment, and then construct a corrective action and preventive action plan
- Describe findings following an inspection, and then construct a corrective action and preventive action plan
- Operate electromechanical equipment (e.g., balance, automated compounded devise, particulate samplers (non-viable and viable), incubator, sterilizers (steam and dry heat), biological indicator and chemical integrator, pH meter, and more)
This learning activity has received financial support from MEDISCA in the form of an educational grant.
| Day 1 | Sign-in 10:30am Training: 11:00AM to 5:00PM |
| Day 2 | Training: 8:00AM to 5:00PM |
| Day 3 | Training: 8:00AM to 5:00PM |
Travel information
The training will take place at the MEDISCA Australia Facility.
FACILITATORS
PATRICIA ULLMANN, B Pharm
Facilitator, LP3 Network Technical Services and Trainings Manager, MEDISCA Australia. Disclosure: MEDISCA Australia Employee.
KERRY WATTS, BPharm, MPhil, GradCertPharmPrac, MSHP
Principal Project Officer for Pharmaceuticals Preparation Policy NSW Ministry of Health, Senior Production Pharmacist, Committee member of the Australian Standards for Cleanroom Environments, Panel member for the Pharmacy Council NSW.
KETI TRAJCEVSKI
TAE40116 (Training and Assessment), HLT47115 (Hospital/Health Services Pharmacy Support)
A2304MED1 (Full Course)
This activity has been accredited for 36 hrs of Group 1 CPD (or 36 CPD credits) suitable for inclusion in an individual pharmacist’s CPD plan which can be converted to 36 hrs of Group 2 CPD (or 72 CPD credits) upon successful completion of relevant assessment activities
The 2016 Competency Standards addressed by this activity include | |
1.1 | Uphold professionalism in practice |
1.2 | Observe and promote ethical standards |
1.3 | Practise within applicable legal framework |
1.4 | Maintain and extend professional competence |
1.5 | Apply expertise in professional practice |
2.2 | Collaborate with professional colleagues |
3.1 | Develop a patient centred, culturally responsive approach to medication management |
3.4 | Compound medicines |
3.6 | Promote health and well-being |
4.4 | Participate in organisational planning and review |
4.5 | Plan and manage physical and financial resources |
4.6 | Plan, manage and build human resource capability |
4.7 | Participate in organisational management |
COMPLETION REQUIREMENTS
Activity participate are required to achieve a 75% passing grade associated with a self-study learning assessment prior to attending the live event.*
Attend the live seminar in full (login and logout times will be recorded).
Completion of a practical skill set competency evaluation
Submit a completed live event evaluation form online within 14 days.
*A maximum number of two attempts is permitted to achieve a 75% passing grade, for both all assessments and competency evaluations.
CANCELLATION AND REFUND POLICY:
In the event that LP3 Network cancels a course, LP3 Network's sole liability shall be course repayment. In no event shall LP3 Network be responsible for any costs related to travel and/or accommodation. A written request must be sent to LP3 Network Inc. requesting ‘Cancellation without Transfer’ to an alternate live activity event date. If cancellation occurs at greater than or equal to 31 days from live activity event date, then registrant will receive a 75% refund; 15-30 days a 50% refund; and less than or equal to 14 days no refund. There are no refunds, returns, or transfer requests upon purchase of a home study, digital work book, webinar, and eLearning modules. LP3 NETWORK INC. shall be excused from any delay caused by reason of any occurrence or contingency beyond its reasonable control (a “Force Majeure”), including but not limited to, acts of God, hurricane, earthquake, labour disputes, strikes, riots, war, and governmental requirements. The obligation to pay money to LP3 NETWORK INC. in a timely manner is absolute and shall not be subject to this Force Majeure provision. In such event, LP3 NETWORK INC. will not issue any refunds, only transfer to an alternate live activity event date.
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
CANCELLATION AND REFUND POLICY
In the event that MEDISCA Australia cancels a course, MEDISCA Australia’s sole liability shall be course repayment. In no event shall MEDISCA Australia be responsible for any costs arising from such cancellation, including but not limited to travel and/or accommodation.In the event a Registrant cancels their enrollment in a CPD Activity, a written request must be sent to MEDISCA Australia requesting ‘Cancellation without Transfer’ to an alternate live CPD Activity event date. If cancellation occurs at greater than or equal to 31 days from live activity event date, then registrant will receive a 75% refund; 15-30 days a 50% refund; and less than or equal to 14 days no refund. MEDISCA Australia shall be excused from any delay caused by reason of any occurrence or contingency beyond its reasonable control (a “Force Majeure”), including but not limited to, acts of God, hurricane, earthquake, labour disputes, strikes, riots, war, and governmental requirements. The obligation to pay money to MEDISCA Australia in a timely manner is absolute and shall not be subject to this Force Majeure provision. In such event, MEDISCA Australia will not issue any refunds, only transfer to an alternate live activity event date.This cancellation and refund policy is specific to courses offered in Australia. To obtain information on the cancellation and refund policy for courses offered outside of Australia, please speak to a MEDISCA Australia representative or refer to your course-specific registration page.
TRANSFER POLICY – AUSTRALIA COURSES ONLY
This transfer policy is only applicable to courses that are offered in Australia. Transfer policy is only in effect if requested greater than or equal to 14 days prior to the original live activity event date. Failure to submit “Transfer Request” at least 14 days prior to original live activity event date will default to “Cancellation and Refund Policy”. Transfer policy can only apply one (1) time. Transfer to a new live event date must be within current calendar year. Failure to attend the new live activity event will lead to no refund and will no longer be transferable. Confirmation of new activity date is subject to the approval by MEDISCA Australia based on the number of available seats within the selected live activity event.