In this episode, Dori is joined by the awesome Pratiksha "Patti" Parekh! Join in on the conversation as they cover not only what is happening across our industry today, but also have a great discussion around the powerful effects that dedicating yourself to continuous learning, building nimble maps, and actively participating in giving and receiving supportive mentorship can have not just in our professional lives, but in our personal lives as well. 

Ms. Parekh is a biopharmaceutical, pharmaceutical & combination product consultant with a reputation of solving multifaceted product lifecycle challenges in single-product and multi-product facilities. Currently, she is a Principal Consultant at CAI, an organization that she has been with for almost 15 years.  

She has worked at over ten organizations across the globe and has supported bringing innovative therapies to patients, as well as continuous improvement of existing programs to maintain compliance with global regulations. A highlight in her career was being Deputy Director of Validation at a vaccine organization fulfilling government contracts. 

 Ms. Parekh holds a BS in Biochemical Engineering and a BA in Economics from Rutgers University; an MS in Chemical Engineering from Columbia University; and an MS in Regulatory Sciences from Johns Hopkins University.

Connect with Pratiksha on LinkedIn

*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.

This is a joint Podcast production of ProcellaRX and KENX

We're back with another episode of Women Leading Validation! This time around Dori sits down with Manager of Quality and Regulatory Affairs at MIMOSA Diagnostics, Rucha Patel. Rucha is passionate about driving continuous improvement in Quality, which is clear in this conversation as they discuss her background in the industry, what she currently does at MIMOSA Diagnostics, and her general approach to not only continuously building on her own skills and knowledge, but also how she applies that mindset to fix and improve quality systems and processes in life sciences.

Outside of her professional life, Rucha is passionate about giving back to her home country of India by collaborating with local NGOs and has enjoyed helping to teach rural kids and their parents the importance of education and nutrition as both elements are unfortunately often overlooked in rural parts of India.

Follow Rucha on LinkedIn and enjoy this awesome conversation!

*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.

This is a joint Podcast production of ProcellaRX and KENX

Dori welcomes our latest guest, Kimberly Wallbank, to talk all things Quality in FDA regulated organizations. Together they discuss everything from identifying and mitigating risk, supply chain complexities, why cross-team collaboration is important, improving Quality systems to better meet objectives of delivering safe and effective product more efficiently, and everything in between. Kimberly truly brought a wealth of insights to our audience and this is a great conversation for anyone in the industry to listen in on.

Kimberly is the Managing Owner and Principal Consultant for Quality Systems Services, LLC. With more than 25 years in the industry, she has diverse experience and expertise in assisting pharmaceutical, biotechnology and medical device companies achieve compliance with FDA, EMEA, ISO and other recognized standards.

She applies this experience by collaborating with companies to establish, maintain, and improve their quality systems so they can provide world class healthcare products.  As an industry leader, she navigates the complexities of FDA compliance while maintaining the most efficient processes for their unique business needs and is passionate about developing ways to infuse quality roles into STEM education.

Follow Kimberly on LinkedIn here.

*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.

This is a joint Podcast production of ProcellaRX and KENX