How Sumatha Kondabolu learned quality assurance and how RAPS membership helps her
Sumatha Kondabolu is a senior quality specialist with Qualio in Montreal, Canada and the vice chair of the RAPS Quebec Local Networking Group. At RAPS Convergence, she talked to us about how she supports her customers, the one skill all regulatory professionals need to have, her experience as a RAPS presenter, and more. This conversation has been lightly edited for clarity.
What is your current role?
My current role is in life science quality. I work for Qualio, an electronic quality management system. We provide a cloud-based SaaS platform to over 650 companies worldwide. I support our customers to set up, populate and start using their Qualio systems in line with their specific quality and regulatory requirements — whether that's the EU MDR, ICH pharma guidelines, ISO 13485 or related to other applicable regulatory requirements. I provide the regulatory expertise and the templated system content to get our customers ready for compliance quickly and easily.
What do you like about your role?
My main role is I help customers bring their products to the market quicker. That's where my expertise is. Regarding my background, I’ve worked in both pharmaceutical and medical devices for almost 20 years now. I use my expertise to help them understand the regulatory requirements and show them how they can adapt within their QMS system. This helps them to comply with the requirements and make sure their product is launched into the market successfully.
How did you get into regulatory?
I started working in a bioanalytical lab, which was a commercial organization, and then I also worked in discovery. This is how I learned quality assurance. I really enjoy working in the quality assurance field because it's like an ocean, like you can swim as much as you can.
I have applied my QMS expertise in all different fields, like starting from lead molecule developmental and clinical trials and then into the animal facilities. And then apart from this, I'm also a certified auditor and this is how I have done different certifications, too.
What is one skill you think all regulatory professionals should have?
One skill they need is to understand the requirements and how they can bring that learning into the real environment. This is very important because we learn a lot from the various regulatory requirements when it comes to bringing that learning into reality. That's what I would say one should understand. And then also have the skills to implement the regulatory requirements.
Why are you a RAPS member?
That is a very good question! I like interacting with various regulatory professionals. And apart from this, there's a lot of learning I can do from becoming a RAPS member, where I take different training courses. And I also provided a sponsored webcast for RAPS from our company. So, I was a speaker for a few presentations.
What was it like to present a RAPS sponsored webcast?
It has been a very good experience with RAPS because everything is very well organized. I was able to know exactly what I'm doing and who the target audience was. I appreciate the overall experience of organizing and delivering webcasts for RAPS.
What has been the highlight of attending RAPS Convergence?
The highlight is that it's in my hometown where I'm living, so that is good. And another point is that I met so many people from various fields here at RAPS Convergence, specifically the regulatory professionals. The events, the topics selected, I learned a lot from these sessions.
What is one thing you learned at RAPS Convergence?
I learned a new update on FDA requirements which are upcoming. And I also learned about the various companies exhibiting. Some I didn't know before, so now I know more about their products and how and what they are doing.