For today’s Women Leading Validation spotlight conversation, Dori Gonzalez-Acevedo CEO of ProcellaRX interviews Wendy Haines, PhD, DABT, ASQ CQA, Director of Toxicology & Technical Services at PharmEng Technology

Wendy has impacted human health laws at Environmental Protection Agency (EPA) starting in 1997, worked on the Genome Project between EPA and National Institute of Health (NIH), and later conducted her PhD at EPA. Wendy was a study director and functioned as single point of contact for all aspects of a study for both commercial clients and the government. She then moved from a contract laboratory setting to a consultant company providing toxicology, project management, and validation services to pharmaceutical and biotechnology manufacturers. Dr. Haines has conducted over 350 product toxicology safety risk assessments for contract manufacturers and owner companies and provides guidance on product testing, worker safety programs, cleaning validation, and extractable and leachable projects.

Wendy’s unique perspective, understanding of professional societies – how you can participate, volunteer and network with others to expand your knowledge.

*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

In this episode, we welcome VP of of IT Training, Growth & Development at United Wholesale Mortgage, Jillian Mantua.

Jillian is passionate about developing and guiding teams through the uncharted territories that come with organizational transitions and rapid growth by leveraging best practices across all industries. She focuses on identifying what and how to do things differently than current day practices, how to bring out the best in employees, and true alignment with organizational values.

Tune into hear Dori and Jillian discuss a variety of topics around the importance of fostering and developing growth within an organization to achieve operational efficiencies, and the recipe that United Wholesale Mortgage has developed to do just that.

Follow Jillian on LinkedIn here and don't forget to rate, subscribe, and share this podcast with friends and colleagues!

*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 Gonzalez-Acevedo CEO of ProcellaRX interviews Ann Vu, JD, RAC, currently of Sr. Vice President, Quality, Regulatory and Clinical at ZimVie. Ann brings more than 25 years of quality and regulatory experience in the medical device, pharmaceutical, nutritional and biologics sectors. Ann oversees quality and regulatory compliance across our global organization. Ann joined ZimVie from Zimmer Biomet, where she led Quality and Regulatory Affairs for Robotics and several other business units. She has also held progressive leadership roles with global companies, including Ethicon, Ortho Clinical Diagnostics, Bausch + Lomb, and Steris. Dori and Ann are fellow Chief members and are passionate about Women Leading Validation!

*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

For today’s Women Leading Validation spotlight conversation, Dori Gonzalez-Acevedo CEO of ProcellaRX interviews Connie Hetzler Global Head of Validation, Alcon Laboratories and Lisa Sykes-Winstead Site Quality Head, Senior Director, Resilience

Connie and Lisa shared their insights into what's it means to be women in leading roles in validation, their day to day experience and why mentoring and sponsorship is important. This was recorded live with Dori on Day 2 at KENX’s GMP University August 2022.

*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

In this fantastic episode, Dori Gonzalez-Acevedo and Professor Sue Black OBE get into a highly engaging discussion around Sue's personal journey in tech and beyond, the programs she's established to support women in tech, and her role in preserving Bletchley Park.

Please don't forget to subscribe, rate and share!

Connect with Sue on LinkedIn: Professor Sue Black OBE

*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

On today’s episode of Women Leading Validation, Dori Gonzalez-Acevedo, CEO of ProcellaRX interviews Katie Terry.

A fellow Chief member, Katie is a life science executive bringing over 20 years of experience in drug development, quality, and manufacturing. She holds a bachelor of science in biology from Utica University and a MBA from Simmons School of Management. Katie has held leadership roles at Biogen, Alnylam, and most recently Acceleron, where she was the Vice President of Quality. She has a passion for building global high performing teams, transforming early stage firms nearing commercialization, and promoting a compliance-centric culture. Katie recently transitioned to consulting where she advises life science executives on topics such as quality management systems, manufacturing strategies, and commercial launch readiness.

*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