01 Nov Meet Our EU FMD Specialist: Dhermita Desai
One quality that sets OPTEL apart from our competitors is the exceptional support our people provide to our customers. Earlier this year, we hired London, U.K.-based EU Falsified Medicines Directive (FMD) expert Dhermita Desai as senior project manager focused on our EU pharma serialization business. We’ve had some time to get to know her, and with EU FMD regulations taking effect February 9, 2019, we’d like you learn more about Dhermita’s extensive serialization background in pharma.
Tell us about your background (work, education) and how you became interested in your current role as a senior project manager.
I worked in various fields in the pharmaceutical industry for 11 years before joining OPTEL, starting as a laboratory analyst for a stability department and then moving into to quality control and quality assurance. In my position testing the quality of the medication, I developed an interest in drug formulation and manufacturing, which took me to the field of technology transfers for globally marketed products. There, I had an all-encompassing pharma industry experience performing a variety of tasks, including testing raw materials, configuring pharmaceutical dosage forms (e.g., sterile, solid dosage, suspensions), and testing the finished product and packaging.
At my last employer, Concordia International Corp., I was given the opportunity to lead the serialization program, which involved building a team, selecting a vendor and implementing the serialization program across the entire business. My work at Concordia included managing the status of the 90+ contract manufacturers and identifying internal department roles and responsibilities.
OPTEL recruited me for my project manager position because during the past three years, I have concentrated my focus on EU FMD serialization and truly understand the critical role CMOs and CPOs play in the interoperability of supply chains.
What do you like about working for OPTEL and with the Verify Brand Software?
There’s a tremendous spirit of teamwork, excellence and respect at OPTEL It’s also a fun and friendly place to work; everyone is very helpful when I have questions. Even though I work in a different time zone, I feel connected to the team, and appreciate that the company’s leadership recognizes every team member’s work and efforts.
How is the Verify Brand Software helping EU pharma organizations meet FMD compliance mandates?
There are a few ways of doing business that differentiate the Verify Brand Software in the marketplace.
Most importantly, OPTEL understands that each organization is unique and has different requirements, and therefore, we tailor our serialization solution to suit each customer’s specific needs.
We provide support to our customers in a variety of ways, from initial project scoping to implementation and deployment. For example, we track the progress of the platform implementation and connectivity with all our customers’ trading partners, ensuring a compliant connection, and provide our customers with regular status updates. We also author all the validation documentation on behalf of our customers.
Finally, OPTEL believes good communication and timely information is critical to a successful implementation. As such, we help our customers navigate the EU Hub registration process and give them guidance on how they should complete the online questions. We also give our clients weekly and monthly updates on the status of the National Hub activations and help them complete any necessary documentation for the National Hubs.
Ok – now for the really interesting part. Tell us a little about your life outside of work. What are your hobbies and/or what do you do for fun?
I enjoy cooking and baking, which are interests that stemmed from watching Australian MasterChef and the Great British Bakeoff (a British baking contest) as well as sampling different cuisines while travelling. I spend a lot of time volunteering with local community organizations, and for more than a decade, have been actively involved with Plan International, a charity that aids children living in the world’s poorest communities. I also enjoy going to music concerts and was inspired by Ed Sheeran many, many years ago (before he became famous) to learn to play the guitar.
To hear Dhermita talk about how you can prepare for EU FMD implementation, join our November 14 free joint webinar with OPTEL and Be4ward, “EU Falsified Medicines Directive: How to Plan a Comprehensive Plan with Rapid Implementation.”