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THE SCIENCE OF PHARMACEUTICAL COMPOUNDING®:

Non-Sterile Training

ACTIVITY DESCRIPTION

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.

INTENDED AUDIENCE

Pharmacists and Technicians new to compounding or with an existing compounding practice.

ACTIVITY DESIGN

A two part activity; self-study with learning assessment and live event with competency assessment.

OVERALL LEARNING OBJECTIVES OF SELF-STUDY EVENT FOR PHARMACISTS

  1. Relate unique and essential central core concepts
  2. Describe regulatory framework requirements
  3. Discuss standards of practice for non-hazardous and hazardous drug compounding
  4. Explain components of a standard operating procedure
  5. Apply business, marketing, and sales for a successful practice
  6. Explain characteristics for routes of delivery in non-sterile compounding
  7. Describe the chemical composition of different dosage forms
  8. Identify laboratory practices, procedures and preparatory techniques related to the compounding of non-sterile dosage forms
  9. Relate excipients to dosage forms, chemical composition, and routes of delivery
  10. 1Relate base types to dosage forms, chemical composition, and routes of delivery
  11. Illustrate the importance of drug monographs and certificates of analysis to compounding
  12. Describe techniques and technology used during compounding
  13. Apply the components of process development
  14. Describe the components of a master formulation record
  15. Discuss the requirements of a compounding record

*For Technicians, please refer to the workbook for Learning Objectives.

OVERALL LEARNING OBJECTIVES OF LIVE EVENT FOR PHARMACISTS

  1. Explain compounding as a viable therapeutic option
  2. Express unique marketing messages in support of a compounding practice
  3. Demonstrate the ability to manage expenses and revenues using a financial spreadsheet
  4. Assess acquisition costs in order to establish selling prices related to a compounding practice
  5. Write a standard operating procedure
  6. Apply regulations and standards to a non-hazardous and hazardous drug compounding practice
  7. Develop preparatory procedures for solutions and dispersions; suspensions and emulsions
  8. Solve pharmaceutical calculations used in pharmacy compounding
  9. Relate process development to the establishment of a master formulation record
  10. Prepare a master formulation record
  11. Design a non-sterile compounding facility in compliance with standards of practice
  12. Prepare a series of non-sterile compounded preparations
  13. Apply qualitative and quantitative assessments to compounded preparations

*For Technicians, please refer to the workbook for Learning Objectives.

FACILITATORS

Branko Radojkovic, B Pharm

Pharmacist, Royal Prince Alfred Hospital; Training Facilitator, MEDISCA Australia

Claire Targett, B. Pharm

Pharmacist Capital Chemist Charnwood; Training Facilitator, MEDISCA Australia.

Ken Speidel, RPh, BS Pharm, PharmD, FIACP, FACA

Vice President, Gates Healthcare Associates; Surveyor, ACHC/PCAB; Fellow, IACP and ACA

Kenneth Latta, RPh, BS Pharm, FIACP, FACA

Senior Associate, Gates Healthcare Associates; Senior Associate, Visante; Consultant, North Carolina Board of Pharmacy; Vice President, ProPharma Cleanrooms.

Mark Filosi, BS Pharm, RPh

Compounding Pharmacist and Co-Founder, Family Care Pharmacy; Surveyor, ACHC/PCAB.

Patricia Ullmann, B. Pharm

Training and Technical Services Manager, MEDISCA Australia.

Paul Cameron, BPharm

Pharmacist, Dallas Parade Compounding Pharmacy; Training Facilitator, MEDISCA Australia.

Rebecca O’Grady, BPharm, MPS GradCertPharmPrac

Technical Support Services Pharmacist, MEDISCA Australia

Tammy Nguyen, BPharm, MPS

Compounding Pharmacist, MEDISCA Australia.

Valentina Karan, BPharm

Product Development Management, The Compounding Pharmacy Australia; Consultant, MEDISCA Australia.

ACCREDITATION

APC Accredited CPD

A1905MED2
This CPD event has been accredited for 48 hours of Group-2 CPD (or 96 CPD credits), suitable for inclusion in an individual pharmacists CPD plan. The activity accreditation expires 1 May 2022.

COPYRIGHT

Activity material is Copyright© 2003-2019 LP3 Network Inc.

COMPLETION REQUIREMENTS

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 achieve credit for the live event.

DECLARATIONS AND DISCLOSURES

This activity is independent of any known bias, prejudice or commercial interest. Both MEDISCA Australia and LP3 Network assist with the marketing of this activity. LP3 Network is an independent corporation. LP3 Network has an established agreement with MEDISCA Australia ensuring that it has no influence on LP3 Network as it relates to activity offerings.

FINANCIAL SUPPORT

This learning activity has received financial support from MEDISCA Inc. in the form of an educational grant.

HOTEL ACCOMMODATIONS

Special rates for hotel accommodations have been arranged for activity participants. Payment for hotel accommodations is at the expense of the activity participant.

FOOD AND BEVERAGE

As a matter of activity programming, meals and refreshments during live activities have been provided by MEDISCA Australia.

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.



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