Pharmacy compounding aseptic isolator training, 1 day
Pharmacist and technician sterile pharmaceutical compounding isolator training. Aimed at those interested in refreshing or expanding their knowledge of sterile compounding using an isolator. The Pharmacy Aseptic Isolator Training Workshop will cover legislative non-hazardous and hazardous compounding including clinical trial and GMO risk assessment, general isolator operational processes and monitoring.
This workshop is suitable for those working in aseptic pharmaceutical production.
Learning Objectives
- Discuss and apply National/State Legislation to aseptic non-hazardous and GMO compounding
- Apply PIC/S PE010 standards of practice and APF and PBA guidelines to aseptic compounding
- Discuss the process for OGTR certification to implement GMO compounding
- Differentiate between a pharmaceutical isolator and a compounding aseptic isolator
- Identify the different components of a compounding aseptic isolator
- Identify the basic principles of maintenance, calibration, and validation
- Identify the required standard operating procedures (SOP) for aseptic compounding in isolators
- Demonstrate changing of isolator gloves
- Demonstrate two phase material transfer of items in and out of the isolator
- Demonstrate handling of triple wrapped sterile items
- Demonstrate cleaning of the isolator, including daily, weekly and monthly rotational requirements
- Describe the requirements of a Quality Management System of aseptic compounding in isolators
- Complete a risk assessment for a genetically modified product
National Competency Standards Framework for Pharmacists in Australia, 2016. Competency standards addressed:
- Standard 1.3.1 Comply with statute law, guidelines, codes and standards
- Standard 1.4.1 Adopt a scope of practice consistent with competence
- Standard 1.5.1 Apply expert knowledge and skills
- Standard 1.6.2 Monitor and respond to sources of risk
- Standard 3.4.2 Confirm the availability of suitable resources
- Standard 3.4.3 Apply risk management strategies
- Standard 3.4.5 Prepare products aseptically
- Standard 3.4.6 Prepare cytotoxic or other hazardous drug products
- Standard 3.4.7 Complete appropriate documentation
- Standard 3.4.8 Optimise packaging and supplementary labelling
- Standard 4.1.2 Apply reflective skills for self-assessment
- Standard 4.2.1 Work with established systems
- Standard 4.7.5 Apply and monitor standards of practice
Accreditation number: CX25059
Accreditation statement: This activity has been accredited for 7 hours of Group 1 CPD (or 7 CPD credits) suitable for inclusion in an individual pharmacist’s CPD plan which can be converted to 7 hours of Group 2 CPD (or 14 CPD credits) upon successful completion of relevant assessment Activities
All content included in the Pharmacy Compounding Aseptic Isolator – 1 day Workshop is the intellectual property of Kaplar Consultancy and cannot be copied or shared.
Registration details:
- Registration price: $850*
- Our training consultant will deliver the workshop at your location
- Minimum of 5 attendees. Registration Price does not include GST.
Contact us by email sales@kaplar.com.au to book!
*Disclaimer: Kaplar Consultancy specialises in medicine and medicinal products for human use. While we can provide training for legislative, infrastructure and equipment needs in the preparation on veterinary products, we cannot provide advice on the safety and efficacy of master formularies for veterinary products.
Cancellation policy
- Cancellations received more than 6 weeks prior to the event will receive a full refund.
- Cancellations received within 6 weeks of the event will receive a 50% refund of the registration fee.
- Kaplar Consultancy reserve the right to cancel a workshop or make changes to the program. If Kaplar Consultancy cancels a workshop you will receive a full refund.