19 July 2021
Powered by MTPConnect’s REDI initiative, SeerPharma is delivering four new courses to help researchers and companies implement quality management systems and gain accreditations for Good Laboratory Practices and medical product manufacturing.
SeerPharma Partner and Training Manager David Spaulding explained the company had been training and mentoring the medical technologies and pharmaceuticals industry on matters related to Quality Management Systems (QMS) and Good Manufacturing Practices (GMP) compliance for over 30 years and said the lack of quality systems can make or break a research project or clinical trial.
"In some cases, reworking research or rejected products and services due to quality issues can substantially delay commercialisation or create significant stock shortages, causing increased costs and reputational damage,” Mr Spaulding said.
“Throughout the COVID-19 pandemic, Australian companies that wanted to produce medical products, such as face masks and Personal Protective Equipment were unable to assist the pandemic response because they were not ISO 13485 accredited.
“Often we are not approached for assistance until it is too late. These REDI supported courses will help organisations get on the front foot with accreditations and systems, before rejection or rework is required,” Mr Spaulding said.
Quality management systems are recommended for anyone interested in commercialising a product or producing a product and help with continuous improvement, customer satisfaction and overall business success.
Through the training, SeerPharma can help researchers and companies to decide if they should be accredited or aligned with a QMS, decide which QMS is right for their situation and help start their journey to achieve more robust and quality enabled results.
One of the four courses is a free two-hour online QMS Primer that overviews quality management systems, the benefits and what to consider before implementation.
“The Primer is a great introduction of the four key quality management system standards and and is aimed at professionals (such as those considering translating research to a product, service providers to the medtech and pharma industry where quality systems will facilitate business success,” Mr Spaulding said.
“Implementing a QMS has many advantages to your business, including enhanced structure, consistency, control, and greater customer satisfaction. The ISO 9001 Quality Management System - Requirements course is for organisations, companies and institutes in the MedTech and pharma sector that want to increase/document the quality and reproducibility of their systems and work and start the journey to implement an effective QMS aligned with or certified to ISO 9001:2015
“For manufacturers and companies intending to manufacture medical devices medical device companies, the ISO 13485 QMS for Medical Devices course is the first step on the path to ISO 13485:2016 certification. It is suitable for companies with or without existing quality system certifications (such as ISO 9001:2015) and applicable to staff who have a role in implementing the system.
“The fourth course on Good Laboratory Practices (GLP) will help researchers and organisations involved in drug development to conduct their experiments, tests and product development programs according to internationally recognised standards of quality. It’s also relevant for research initiatives continuing into the clinical phases of medicinal and MedTech product development.
“Research and operations of MTP companies aligned to and in some cases accredited by quality management systems will ensure Australia is at the forefront of medical innovation,” Mr Spaulding said.