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Leading QA/RA experts take part in the Corona Chat

Leading QA/RA experts participated in the corona chat and shared their stories on how their professional life has been impacted and what measures have been taken to adapt to the unprecedented crisis.

We were joined by Andreas Stange (Manager of Strategic and Business Development IVD, TÜV SÜD), Olaf Nitz (Deputy Managing Director of CODAN ARGUS/ Head of Quality Assurance and Regulatory Affairs), Teresa Perry (Global Quality and Accreditation Manager at BSI), Khalid Azzouzi (Head QA/RA/CL at AXIUM), Oliver Bisazza (Director of Regulations and Industrial policy at MedTech Europe) and Megha Deviprasad Iyer (Global Director Regulatory Affairs at Thermo Fisher).

Oliver Bisazza gives us a great overview of the current situation. It is a challenging time as the COVID crisis has increased the global demand for medical devices and testing kits. Meeting global demands and implementing restrictions to curb the spread of the virus is challenging. There has been a decrease in non-essential medical procedures but on the other hand, the demand for certain medical equipment like protective equipment, ventilators, and testing kits has gone up. Until now, the focus had been on implementing the new regulations (MDR/IVDR), but everybody has had to adapt, in order to respond effectively to the crisis.

The Impact

All of our guests on the Corona Chat spoke about the new “normal” that is, working from home. Overall the feedback was very positive. For some, like Teresa Perry and Khalid Azzouzi, the change to becoming home-based, was not such a big one as it was something they’d been doing before. For others, like Andreas Stange, who typically spends most of his time traveling, the chance to spend some time at home with family and embrace the powers of modern technology have been very well received.

Teresa Perry, highlighted the importance and responsibility of companies to make sure they don’t forget about the emotional and mental wellbeing of their employees. She says, “…our staff’s well-being is at the forefront of our minds…”. She believes that technologies like video conferencing are essential for working but they can make it hard to keep close contact with the teams so it is crucial to make sure people are dealing with isolation and social distancing.

Megha Deviprasad Iyer, who, working for an IVD company producing over 5 million tests per week – spoke about the challenge of not only having to adapt to working from home, but having to learn about new emergency clearance pathways and apply for them in real-time.

Olaf Nitz- working in a medical device manufacturer producing infusion pumps spoke about the significant increase in demand, and the knock-on effect of having to hire and train more staff quickly, whilst at the same time ensuring product quality remains at a very high standard.

Adapting to the New Normal

Andreas Strange, who works in a management team with TUV SUD says that the one main thing that has changed about his work is not going to huge conferences. He also shared that the company has adapted well to the new situation by embracing online tools and taking discussions and training online.

The corona crisis has also made it impossible to carry out onsite audits because of social distancing restrictions. Remote audits are the new thing although it comes with its own challenges.

Winning hearts and minds

Olaf Nitz (Deputy Managing Director of CODAN ARGUS/Head of Quality Assurance and Regulatory Affairs) shares the challenge of getting employees to see the “big picture”. Some employees were allowed to work from home while others had to work from the office as it was critical to ensure production. It was essential to keep them motivated by helping them to understand the importance of the work they were doing.

Once they were convinced of the bigger vision and the huge impact they were making they were motivated to do their job and proud to be part of the solution.

Risk management

Khalid Azzouzi spoke about the importance of taking decisions in a crisis situation. Ensuring a constant flow of products, whilst keeping in mind patient safety. Looking towards the future, companies need to learn from this crisis by doing risk management, not only for the product, but also for the supply.

The future

The Corona crisis has changed the world view significantly. All agreed that the future will be more virtual. Andreas Strange believes that companies will continue to embrace virtual tools and technology in the future. Megha Deviprasad Iyer is optimistic that the current crisis will encourage companies to become more flexible. She says that with flexibility she “would like to see the final nail in the coffin of presentism and the 9 to 5 work pattern”.

Megha also spoke about what this would mean in terms of talent. Companies that have more flexibility will be able to hire RA professionals across the globe as they have a “wider talent pool” to choose from. The employers are most likely to continue embracing technology and reap benefits of the virtual world.

Khalid believes that there are learnings from the COVID-19 crisis that companies need to apply for in the future. He believes that it is time to think about “risk management” for the products and supply. There is no guarantee that something like the Corona crisis will not happen again and focussing and risk management can help companies to be “better organized’”.

On remote audits Teresa Perry was optimistic. She believes that the Corona crisis has provided us with the evidence that remote audits are a possibility. She says that BSI is interested in developing new practices and techniques to support remote audits.

She states that remote audits have been “well received” by the clients. Proper preparation like having essential documents at fingertips and technologies at our disposal can help in dealing with challenging processes of remote audits.

Altogether, the COVID-19 crisis has forced companies to rethink their perspective on so much; on flexible working, on business tools, on the traditional 9-5, and so much more. Companies that were hesitant or unable to embrace technologies and remote offices have been forced to do just that. As we move into the future – the question arises, what will it look like?

The employer of the future will be the one who embraces the key learnings from this crisis in order to be able to be more agile, flexible and overall more human, than ever before.

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