Need help with Australian Authorised Person training and
your release for supply process?
This course is intended for people who are new or need refresher training in the Release for SUpply process and the duties of the Authorised Person for the Australian pharmaceutical market.
This course can help you to:
Gain understanding of the Australian GMP requirements for RFS
Learn the PIC/S GMP Annex 16 requirements recently adopted by TGA
Provide clarity on should be included in the RFS checking process
Learn why RFS relies on underpinning product and process knowledge
Improve your company process for completing RFS
And probably many more!
WHY LEARN FROM KATHY?
See our reviews for training and consulting.
"Having worked with Kathy for many years, I can speak from first-hand experience of the exceptional quality of her work. Her honest, practical approach, and collaborative way of working is what makes her stand out from the rest. The improvements she identified and helped implement to the company's internal audit program resulted in an ISO13485 TGA A1 audit rating. Kathy's valuable service, knowledge and expertise is second to none. I highly recommend her and the QSN team to any company who wants a positive audit outcome."
Senior Quality & Regulatory Manager - GMP/Medical Devices
"Kathy did an extraordinary job leading our ISO17025 accreditation of our company in record time. Since the first day Kathy became an extension of our team and trained the staff not only to set up the quality systems but also so make sure they would own the systems that we were implementing. Kathy led the audit when the assessors were on site and coordinated responses post-audit, with very positive auditor feedback... I highly recommend Kathy to any company interested in the accreditation process, she will maximize the chances of success"
CEO
Biotech
The QSN team helped our company implement a QMS from scratch, and guided our team through accreditation in record time. Our business has been able to grow and access more clinical studies because of QSN’s expertise and Quality guidance.
CEO
Biotech/Clinical
"Our company relied heavily on Kathy and her team at QSN to build a GxP QMS from scratch, including supporting eQMS configuration, validation, SOP detail and process development, and supported our TGA audit... I would highly recommend Kathy and her team at QSN to any pharma start-up or company."
Quality Manager
GMP Pharma
"I personally wanted to say thanks to you and the rest of the QSN team for all the QA and QMS support as we have now received notification that we have passed our ISO 13485 Stage 2 Audit."
QA Manager
Medical Devices
"The masterclass... Documentation Transformation Pathway – Every Industry, Every Business!... was absolutely brilliant, useful, insightful and reminding basic principles in making simpler, easy to understand documents in almost all functions and areas.
QA Manager
GMP Pharma
"QSN helped with our audit readiness - their willingness to provide support and share their knowledge and experience with the team was the best thing about their service."
QA Manager
GMP Pharma
"The best thing about QSN is their knowledge, experience and they're just a great lot of people to work with. They know what they're doing yet they can be humble and always professional on their approach on things!
Project Manager
Medtech
"QSN have a can-do attitude with positive mindset and proactive approach to problem solving. This was a great asset in helping us to focus on solutions and accomplish the tasks at hand."
Operations Manager
Medtech
Excellent videos, clear, concise and very informative. Kathy is a great source of knowledge and her help and advice is always invaluable for us.
Quality Systems Manager
Medtech
Clear structure, right level of details, up to date information, useful for any medicine manufacturers/sponsors. Catering for all customer needs with the text and video.
Quality Manager
Medtech
The course is providing a very clear and sequential training deck which would aid in learning for new trainees and trainees who are refreshing their knowledge.
Quality Manager
GMP Pharma
Very well structured and presented nicely (as expected from a professional writer)
Training Attendee
Kathy is a very pleasant and good communicator with efficient style!
Training Attendee
This was a very clear and informative, to the point, webinar.
Training Attendee
