MEDISCA Australia | The Science of Pharmaceutical Compounding: Non-Sterile Training | Seed Pharmaceuticals 7-8 Jan 2023
The Practice-based Activity will provide compounding pharmacists and technicians with the competency to prepare current and viable pharmacotherapeutic non-sterile dosage forms. Unique concepts will be taught facilitating a decision-making process the pharmacist and technician can apply in their day-to-day practice.
Consideration will be given to meeting the physician’s prescription and patient-specific need, compliance-related solutions, medical necessity, and legal and regulatory guidelines. A significant emphasis will be placed on quality assurance and quality control as it relates to dosage form design, pharmaceutical calculations and the validation of preparatory procedures that are part of Master Formulation Records.
Practical techniques and technology-related applications are developed through hands-on experience in a compounding laboratory environment where pharmacists and technicians will be trained in all aspects of non-sterile preparatory procedures. Pharmacists and technicians have the opportunity to develop important aspects of a business development and marketing plan.
- Relate unique and essential central core concepts
- Describe regulatory framework requirements
- Discuss standards of practice for non-hazardous and hazardous drug compounding
- Explain components of a standard operating procedure
- Apply business, marketing, and sales for a successful practice
- Explain characteristics for routes of delivery in non-sterile compounding
- Describe the chemical composition of different dosage forms
- Identify laboratory practices, procedures and preparatory techniques related to the compounding of non-sterile dosage forms
- Relate excipients to dosage forms, chemical composition, and routes of delivery
- Relate base types to dosage forms, chemical composition, and routes of delivery
- Illustrate the importance of drug monographs and certificates of analysis to compounding
- Describe techniques and technology used during compounding
- Apply the components of process development
- Describe the components of a master formulation record
- Discuss the requirements of a compounding record
Virtual Seminar & Lab Training
- Explain compounding as a viable therapeutic option
- Express unique marketing messages in support of a compounding practice
- Demonstrate the ability to manage expenses and revenues using a financial spreadsheet
- Assess acquisition costs in order to establish selling prices related to a compounding practice
- Write a standard operating procedure
- Apply regulations and standards to a non-hazardous and hazardous drug compounding practice
- Develop preparatory procedures for solutions and dispersions; suspensions and emulsions
- Solve pharmaceutical calculations used in pharmacy compounding
- Relate process development to the establishment of a master formulation record
- Prepare a master formulation record
- Design a non-sterile compounding facility in compliance with standards of practice
- Prepare a series of non-sterile compounded preparations
- Apply qualitative and quantitative assessments to compounded preparations
Activity Schedule Day 1
Business Basics – Physician detailing, financial management, niche market opportunities, collaborative practice model
1 hour 45 minutes
Creating a Culture of Quality – Quality, risk and verification, SOPs, hazardous drug compounding, facility design & workflow, personnel competency and compliance assessments, MFR templates, correlation vs causation
1 hour 15 minutes
Compounding Calculations – Drug monographs, certificates of analysis, conversions, assays, waters of hydration, potency, capsule packing statistic, displacement factors for suspensions and emulsions, cohort stocks, concentrates and aliquots
Activity Schedule Day 2
Compounding Calculations (Continued)
Scientific Principles – Routes of delivery & delivery systems, balancing stability and suitability, compounding by composition, customization with appropriate compromise, prescription assessment, clinical decision making in compounding
2 hours 45 minutes
Scientific Principles (Continued)
Saturday 07.01.23 - 8am to 5pm (1 hour lunch at 12pm)
Sunday 08.01.23 - 8am to 12pm
TAMMY NGUYEN, BPharm, MPS
Consultant Pharmacist, MEDISCA Australia
SARA MONFARED, BPharm, BSc (PCOL), Grad Dip (PCOL), MPS
Compounding Services Pharmacist, MEDISCA Australia
Note: Facilitators are subject to change.
This activity has been accredited for 40 hours of Group 1 CPD (or 40 CPD credits) suitable for inclusion in an individual pharmacist’s CPD plan which can be converted to 40 hours of Group 2 CPD (or 80 CPD credit) upon successful completion of relevant assessment activities.
The 2016 Competency Standards addressed by this activity include: 1.1, 1.2, 1.3, 1.4, 1.5, 2.2, 2.3, 3.4, 3.6
Uphold professionalism in practice
Observe and promote ethical standards
Practise within applicable legal framework
Maintain and extend professional competence
Apply expertise in professional practice
Collaborate with professional colleagues
Promote health and well-being
Home Study: Complete home study learning assessment* prior to the live event.
Live Virtual Seminar: Attend in full, complete learning assessment* and activity evaluation
Lab Training: Attend in full, complete practical skill set competency assessment*, and activity evaluation
*A maximum number of two attempts to achieve a 75% passing grade is required for all learning assessments and competency assessments.
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.