Research and operations of Medical Technology, Biotechnology and Pharmaceutical (MTP) companies aligned with and in some cases certified to Quality Management System (QMS) Standards will ensure Australia is at the forefront of medical innovation.
At SeerPharma we see examples of researchers and companies needing to rework or reject products and services. In some cases this can substantially delay commercialisation or create significant stock shortages, causing increased costs and damage to reputations. Also, throughout the COVID-19 pandemic we know companies that wanted to produce medical products (especially PPE like face masks, hand sanitisers, etc,) to help with the pandemic response, but couldn’t as they didn’t have ISO 13485 certification.
So with the generous support from MTPConnect and the Researcher Exchange and Deployment within Industry (REDI) Program, we are pleased to deliver the four courses below that will help researchers and companies:
- Decide if you should be aligned with or certified to a QMS Standard
- Decide which QMS Standard is right for you
- Help start you on your journey to achieve more robust and quality enabled results
The four courses on offer:
This wholly online, self-paced course provides a overview of quality management systems, their benefits and what you need to consider before implementation. Outlining four key quality management system standards and who they are for, this course is aimed at professionals (such as those considering translating research to a product, service providers to MedTech and Pharma etc.) where quality systems will facilitate business success. It is open to anyone interested in learning more about quality management systems and how they help with continuous improvement, customer satisfaction and overall business success. You may be a subject matter expert, in research, a clinician, in a start-up, a supplier or a graduate with interest.
Implementing a Quality Management System has many advantages to your business, including enhanced structure, consistency, control and ultimately greater customer satisfaction. This course is for organisations, companies and institutes in the MedTech Pharma sector that want to increase / document the quality and reproducibility of their systems and work. This course is not just for workplaces who are planning to obtain ISO 9001:2015 certification, but are wanting to implement a quality system fit for their own needs and purposes. It provides an overview of the ISO 9001:2015 Standard and how the requirements can be met in the MedTech Pharma environment. It will provide insights into key clauses and concepts that underpin an effective QMS. The course will enable you to commence your journey to implementing an effective QMS aligned with or certified to ISO 9001:2015.
Are you looking to implement ISO 13485:2016, or improve the one you currently have? Or are you just interested in how ISO 13485:2016 is implemented and why it is so important for medical device companies? This course is for manufacturers and companies intending to manufacture medical devices and is their first step on the path to ISO 13485:2016 certification. It is suitable for manufacturers and companies with existing quality system certifications (such as ISO 9001:2015) as well as those with no existing certifications. It is also applicable to staff in companies with existing ISO 13485:2016 certification who have a role in implementing the system. Participants will gain knowledge and learn process steps to enable them to effectively implement a quality management system and to meet the requirements for ISO 13485:2016 certification.
Good Laboratory Practice
This course is aimed at helping researchers and organisations involved in drug development to conduct their experiments, tests and product development programs according to internationally recognised standards of quality.
A secondary goal is to help researchers and organisations continue their research initiatives into the clinical phases of medicinal and medtech product development. It is relevant for organisations, companies, institutes and laboratories in the MedTech Pharma sector that want to increase / document the quality and reproducibility of their systems and work. It is not just for workplaces who are planning to obtain Good Laboratory Practice (GLP) certification but are wanting to implement a laboratory quality system fit for their own needs and purposes. This course will provide an overview of GLP standards and how these can be applied in the MedTech Pharma environment. It will provide insights into key clauses and concepts that underpin an effective QMS, enabling participants to commence their journey to implementing an effective QMS aligned with GLP.
If you are interested in learning more, we will be holding a free webinar on Tuesday 17th August at 5PM (AEST) to provide an overview and address any questions you might have.
Supported by the REDI initiative, powered by MTPConnect