With the merger of BioAssist and QualityHub, BioAssist Founder and President Rebecca Fuller has become their newest Consulting Director.
Rebecca has 30 years’ experience in FDA and regulated industry, starting her career as an FDA Investigator. She has worked as Director of Regulatory and QA for several medical device companies, and she has been a consultant since 1996 with specific expertise in risk-based quality system development and FDA compliance remediation. She has led over 200 audits and inspections of drug, device, biologic, and cosmetic companies.
We wanted to sit down and get to know more about her, as well as see what industry trends she’s keeping an eye on. Who better to conduct this interview than Tim Wells, the Founder and President of QualityHub.
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Q:
Thanks, Rebecca, for agreeing to do this interview. It’s been a few months now since you came to work at QualityHub. I’m curious how you like it so far, and what you see as some of the biggest challenges you’re running into?
A:
Thanks, Tim. First, it is a pleasure to be part of the QualityHub team and it really feels like being part of a family. I think we started working together about 16 years ago on audits and remediation programs for some of QualityHub’s clients. We have all gotten to know each other very well over that time and our approaches to serving clients are aligned. I’m excited to continue to support QualityHub objectives to provide the highest level of quality and regulatory services in my new role as a Consulting Director. This role is giving me the opportunity to mentor and coach a cadre of highly skilled consultants. I have always enjoyed training so being able to provide guidance and share my years of experience with our consulting team and our clients is rewarding.
I think the greatest challenge that I am facing is one that anyone who manages projects and people faces and that is time management. I have to keep myself very organized to stay on top of many regulatory compliance projects, QMS remediation work and audits all happening concurrently. Having a good administrative and business support team around me helps tremendously, as well as using tools such as an electronic project triage board. The QualityHub team all works hard to stay in constant communication. While this has been a challenge with many of us working remotely as a precaution during the Covid-19 pandemic, we have quickly mastered the art of Zoom and MS Teams.
Q:
You have an incredible knowledge and experience that includes working in industry and at the FDA. How has that background helped prepare you for your role as a consulting director?
A:
One thing that has really helped me most in my career is having both FDA experience and industry experience. There is a big difference between writing an FDA 483 observation citing inadequacy with a process validation and actually having to perform that validation yourself. For example, the month after leaving FDA to take my first job in industry, I was called into the President’s office and told that the manufacturing facility was relocating and I would be in charge of revalidating all the manufacturing equipment and processes. I had to roll up my sleeves. As a consultant, this kind of real hands-on experience, has enabled me to not just help identify problems and opportunities but develop workable solutions as well. QualityHub is a solutions-oriented company so I think my experience will be directly applicable to the types of projects we routinely execute and of value to our clients.
Another thing that has been helpful is that my long consulting career has enabled me to work with a significant variety of industrial processes and products. I am equally comfortable in a mechanical assembly operation for a complex software controlled medical device, a sterile filling suite for a low volume parenteral drug product or a lab producing monoclonal antibodies. I think over the course of my career I have worked with- or audited- just about every type of manufacturing process used in Pharmaceuticals, Medical Devices, Biologics, and IVDs. And the industry continues to innovate, introducing new challenges. As a Consulting Director for QualityHub, I will continue to have the opportunity to work with novel life-saving products that are being developed, manufactured, and marketed in a global environment. I’ll be able to jump right in as QualityHub’s service areas expand. There is always something new to learn. That keeps me interested in what I do, even after 30 years.
Q:
I know You’ve been pretty excited about Quality Hub’s newest offering: QReview. I am curious, though, what do you see as some of the biggest challenges for the medical device industry as we enter 2021?
A:
The most talked about and challenging issue facing the medical device and IVD industries is the upcoming implementation of the European Union’s new Medical Device Regulation or EUMDR. For many companies, the effective date of May 26, 2021 looms dauntingly on the horizon. It will be interesting to watch the roll-out over the next year, but I anticipate that 2023 will be even more critical as the MDD and IVDR Certifications will become void on May 27, 2024.
Q:
How is QualityHub working with companies to address those concerns you just mentioned?
A:
Many of our consulting team, including myself, have completed their formal training in EUMDR. I did my training with BSI, which was particularly helpful as I was able to get the perspective of an auditor for a notified body. QualityHub’s consultants have been working with companies over the past 18 months to perform gap assessments for EUMDR. We have actively been engaged in updating Quality Management Systems, Post-Marketing Surveillance programs and Risk Management programs and Technical Files to prepare for upcoming Notified Body inspections.
Q:
Rebecca, where do you see QualityHub going in the future?
A:
We are actively expanding our global footprint, especially in Europe, where we have recently added some highly skilled consulting staff to our team. In addition, we have a real opportunity to increase our presence in the Pharmaceutical sector with more Drug GMP, GLP, and GCP audit programs. QualityHub is also expanding services to include more regulatory support for product approvals, such as helping to build and review FDA applications and submissions. I did quite a bit of both drug and device product approval work with BioAssist, so it feels like a good fit. In fact, in the past 3 months, I’ve been directly involved in helping two QualityHub clients with their upcoming submissions. I think in the long term we will also be adding services to support dietary supplements. All of these new offerings, along with our historical service areas, are like the “SPOKES” that radiate out from the “HUB”.
Q:
Rebecca, one final question for you: Anything else in the industry you think people should keep their eyes on?
A:
Besides EUMDR, we are also seeing increased interest in cybersecurity for medical devices. As more medical devices are being used to transfer data in real time both within the patient environment and externally to Health Care Providers, we are seeing more deficiencies being cited in regulatory inspections and audits. We now provide cybersecurity consulting services. In fact, one of our current projects involves helping a client who manufactures combination products that include a software component. We are helping them develop a risk management processes specifically for cybersecurity. This process will integrate with their overall product risk management process.
