Many medical device developers and manufacturers rely heavily on the competence of their staff to achieve their business goals. Like many companies, particularly in the start-up phase, it can be a daunting task to know where to start with documenting the necessary evidence to demonstrate that competence to third parties such as investors and notified or approved bodies.
Under the MDR/IVDR, the requirement to have a Person Responsible for Regulatory Compliance brings the need to demonstrate competence into even sharper focus.
This webinar has been developed to help you understand the ‘big picture’ of competence management from selection of the right competencies for success to maintenance of collective organisational knowledge.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Benefits of Attending
Through attendance on this course, delegates will be able to:
- Identify the competencies required for the growth of the company
- Plan recruitment effectively to deliver competency
- Utilise performance reviews to manage competency
- Document the right information as evidence of competence
This will enhance the company’s ability to meet the competence-related requirements of ISO 9001:2015 clauses 7.1.6 and 7.2, ISO 13485:2016 clause 6.2 and regulatory requirements of Article 15 in MDR/IVDR Person Responsible for Regulatory Compliance (PRRC).
Agenda
What do we mean by “Competence” in the context of the medical device industry?
Understanding an organisation’s competence needs
- Determining types of competence needed from skills, experience, knowledge and qualifications
- Identifying potential sources, internal and external
- Identifying the touch points within the Quality Management System for competence management
Maintaining appropriate records of education, training, skills and experience
Capturing and sharing undocumented knowledge and experience
Utilising external competence resources effectively
Demonstrating competence to third parties
Speakers
Miss Anne Jury,
Anne Jury Associates LtdAnne Jury is a regulatory affairs consultant with over 25 years experience in the medical and diagnostic healthcare products industries. With a degree in Microbiology, she went to work as company microbiologist for Smith & Nephew Textiles on sterile wound dressing products. Later she went on to work for Notified Bodies, BSI and then TÜV Product Service as a lead auditor covering over 200 medical companies in Europe and USA.
Anne is a member of TOPRA, (The Organisation for Professionals in Regulatory Affairs) and RAPS, (Regulatory Affairs Professionals Society) and a regular speaker at conferences world-wide. Through close association with like minded organizations such as Medilinks, the DTI and NHS Innovations Hubs as well as biotechnology incubators around the UK, she is active in the promotion of integrated management and regulatory systems to assist the successful introduction of new products to market.Since March 2020, she is also Vice President of Team-PRRC.
Specialties: Technical guidance on regulatory strategies and quality management systems for new medical device product commercialization, including CE marking requirements, implementation of management systems to ISO 13485:2016 and training / coaching in these areas.
Gap analysis compliance audits for manufacturers and subcontract third party auditor for Notified Bodies.
Past visiting lecturer at Cranfield University (through TOPRA) on MScs in Medical Technology Regulatory Affairs.
Vice-President of Team-PRRC, a non-profit association in EU to support those taking on the PRRC role under MDR and IVDR.
Who Should Attend
- Quality Assurance managers
- Regulatory Affairs associates
- Human Resource managers
- Senior Management
