Advanced Manufacturing and Supply Chain
The following Advanced Manufacturing and Supply Chain programs are offered by our REDI partners
Centre for Biopharmaceutical Excellence (CBE) Consortium
GMP UPLIFT Program
CBE GMP Uplift Programs will provide participants a real-world perspective on Good Manufacturing Practice (GMP), designed to assist with the interpretation and application of GMP in practice for those involved in human health products.
Essential GMP Program
Is for entry level employees (new starts up to 12 months) and is a five day equivalent course, designed for participant flexibility in upskilling in fundamental GMP principles. Topics include core concepts of GMP, two elective modules across Biologics, Pharmaceuticals, Regenerative Medicines and Quality Control. Followed by GMP Workshops demonstrating the application of GMP in practice and hands-on training with application of key tasks in an experiential GMP environment. Sessions are scheduled around Australia from Q3 2022.
Advanced GMP Program
Is for those in a GMP role (12 months+) giving an in-depth understanding of the critical areas underpinning GMP compliance in practice. Advanced Short Courses are complementary and for those wanting to upskill across Risk Management, Investigations and Root Cause Analysis, Validation, Aseptic Practices, Audit Readiness and Advanced QMS. Designed for busy professions, facilitated online sessions will be scheduled from Q3 2022.
CBE brings strong technical credentials, from consulting and GMP related enterprise training and will lead the Consortium. The Consortium includes CBE, ARCS Australia, Merck Life Sciences Australia, as well as the CBE Pure Solutions VIC, Translational Research Institute (TRI) T3 Cleanrooms QLD and UTS Biologics Innovation Facility (BIF) NSW experiential training facilities, where the Essential GMP Workshops will be held.
Quality System Primer
This is a wholly online course. Participants will gain an introductory understanding of quality management, types and standardised Quality Management Systems and how they support MTP commercialisation: ISO 9001, ISO 13485, ISO 17025 and Good Laboratory Practice (GLP). This online training can be completed anytime from anywhere and will also help participants determine which bootcamp (ISO 9001, ISO 13485 or GLP) to take.
ISO 9001:2015 QMS Bootcamp
Targeted for organisations, companies, institutes and laboratories that want to increase/document the quality and reproducibility of their systems and work. This 3-day bootcamp will give participants in-depth knowledge of the ISO 9001:2015 quality management standard and how it can be applied. Sessions are scheduled around Australia from August 2022.
ISO 13485 QMS for Medical Devices
This course is for manufacturers and companies intending to manufacture medical devices that must comply with ISO 13485:2016. This 4-day workshop will provide participants with the knowledge and process steps to enable them to effectively meet the quality management system requirements for medical devices. Sessions are scheduled around Australia from August 2022.
Good Laboratory Practice (GLP) Alignment Bootcamp
This course is for MTP businesses, institutes and laboratories that want to increase/document the quality and reproducibility of their systems and work. This 3-day course will teach you the GLP standard and how to start implementing an effective quality management system for your laboratory. Sessions are scheduled around Australia from October 2022.
SeerPharma is a team of consultants that provide advice, training, software solutions from MasterControl, and contract labour resources to pharmaceutical, medical device and life science companies in the Asia-Pacific region, on matters of Quality Assurance and GMP compliance.
Website: SeerPharma | Twitter: @SeerPharma_GMP | LinkedIn: SeerPharma