QA/RA Leader Medical Devices

Course description

This 2.5-days tailor-made training is led by experienced trainers and combines theory with reality-based work-shops. The aim of the training is to make you well equipped to lead the (QA) RA function in a medical device organization and provide a great opportunity to network with other colleagues in similar roles.

When combined with in-depth training in Quality Management system and Medical Device regulations, such as our advance level training course “Medical Quality Management Systems” you are well prepared for the position as QA-RA Leader, and the role as person responsible for regulatory compliance (PRRC)[1].

The training includes: 2 hours online introduction, 2 days on-site, and 2 hours summary of key take-aways and time for open questions after the training.

[1] The new EU regulations for medical devices (MDR) and In Vitro Diagnostics (IVDR) requires the manufacturer to appoint a person responsible for regulatory compliance (PRRC) who has specific responsibilities and must show documented evidence of expert knowledge in relevant fields.

Course outline

• Regulations and Quality system – purpose of regulations and of quality systems, how they work together and where they differentiate. The role of ISO 13485 and MDSAP. International actors/cooperation, the role of IMDRF and how standards/standardization can contribute
• Definitions – the importance of understanding the definition of a medical device vs other regulated products such as drugs and cosmetics. Overview of Regulations for borderline products and combination products..
• Your role – the typical responsibilities of a QA/RA Manager. Discussion about potential responsibilities of a QA/RA Manager from a regulatory perspective and strategies for risk mitigation for you and the organization.
• How to assess if the Quality Management Systems in your company is efficient and compliant – ways to make an accurate assessment of whether a QMS is efficient and compliant, what inspectors (FDA, NB, MDSAP auditors and others) will look for and how to prioritize when the results are negative, or “out of limit”.
• Management review; management responsibility for ‘monitoring, measurement and analysis’ – how can output from MR be used, what inspector will look for, how to get “management buy-in” and how to communicate also negative results to drive commitment and action.
• Vigilance – expectations for reporting in different regions; how to deal with challenging situations related to certain complaints and how to take the decisions to perform recall/FSCA.
• Change control and notification processes – When changes need to be reported, what to report and how.
• Stakeholder relationships – About the relationships to distributors, contract manufacturers, key customers, Original Equipment Manufacturers (OEMs) and how responsibilities are placed on different roles.
• Regulatory strategy – preparation to compile a relevant list of questions that can be used to create a relevant regulatory strategy/regulatory plan depending on the device classification, your legal role and regulatory requirements.

Learning objectives

After completion of this course you will be prepared to…

• Understand how medical device regulations are designed and expected to be observed.
• Prepare or provide input to documents such as “Intended purpose’, “Regulatory strategy”, ‘Design and development Plan’ or ‘Risk Management Plan’, from a QA-RA perspective.
• Maintain product safety when the product is put on the market, by working with an implemented management system, including risk management and market surveillance.
• Monitor for, and implement, changes in standards and regulations
• Take on the role as PRRC either on your own, or together with delegates.
• Other responsibilities of a QA-RA Manager such as marketing & claims, distributor relations and outsourcing.

Who should attend

The training is suitable for quality and regulatory professionals who want to strengthen their competency in medical device regulation and quality management systems, and need documented competency as “person responsible for regulatory compliance”.

It is also designed to serve as preparation for a personal certification as “QA/RA Leader Medical Devices” (read more about the certification at www.sbq.nu.)

Take this training if you:

• are experienced in the role as a Quality/Regulatory Manager or Quality Leader and wants to develop yourself further and get your skills documented.
• need professional development that will benefit both you as individual and the organization.

Prerequisites

Two years’ experience or more of working with quality and regulatory questions in medical device or pharmaceutical industry. Training/knowledge about QSR and ISO 13485 corresponding to the content of our course “Medical Device Quality Management Systems (QMS)”

[1] The new EU regulations for medical devices (MDR) and In Vitro Diagnostics (IVDR) requires the manufacturer to appoint a person responsible for regulatory compliance (PRRC) who has specific responsibilities and must show documented evidence of expert knowledge in relevant fields.

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