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

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

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

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

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

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

For today’s Women Leading Validation spotlight conversation, Dori Gonzalez-Acevedo CEO of ProcellaRX interviews Co-Founders Tanya Sharma and Krisha Patel of Assurea.

This dynamic duo is leading the way for young entrepreneurs in a variety of ways, not just about validation. Tanya is a cofounder at Assurea LLC, a quality compliance consulting firm for startup biotech companies. She is on the international steering committee for Women in Pharma, ISPE. Her background is in cloud compliance and CSV. She supports several blockchain pilots and use cases within supply chain.
Krisha Patel is a cofounder at Assurea LLC and helps biotech startups navigate complex regulatory challenges as they scale up. Her expertise is Quality and has built frameworks for Quality Systems for several cell and gene therapy companies.

Their #rootingforyou is a great way to make an impact today! Take the pledge! Spread the word! 

*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 Denise Dajles, Senior VP of R&D, Regulatory and Quality Denise Dajles, Senior VP of R&D, Regulatory and Quality  at Sientra located in Santa Barbara, California and fellow Chief Member.  Denise graciously shared her day, experience, and thoughts with Dori on Day 2 at KENX’s GMP University August 2022.  

Denise is a Biomedical Engineer with a Bachelor’s and a Master’s degree from Washington University in St. Louis, and is currently pursuing a Doctorate in Engineering Management from George Washington University. Denise has over 15 years of experience, both in industry and academia, leading new product development, global regulatory affairs, and quality management in medical devices. After working for companies such as Inamed, Allergan, and Prosein, Denise transitioned to Academia, where she led a Research Lab focused on brain computer interfaces, being the first women to lead a Research Lab in the Electrical Engineering department and oversaw over 10 different research projects. Ms. Dajles returned to corporate life after more than six years dedicated to research and teaching to lead the R&D department of Establishment Labs, an Aesthetics Medical Device company, successfully developing over eight different products, taking them from concept to market. Ms. Dajles currently serves as the Sr. VP of R&D, Regulatory, and Quality at Sientra, also an Aesthetics Medical Device Company, and is responsible for developing the innovation strategy, which includes managing the technology roadmap to address current and anticipated customer needs, leading the design, planning and implementation of the company’s global regulatory strategy and quality system, as well as scouting and assessing new technologies and business development opportunities. Ms. Dajles is also a co-author of several publications in peer-reviewed journals and a book chapter and is a named inventor on a number of medical technologies.

*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

This month’s episode of Women Leading Validation, Dori Gonzalez-Acevedo CEO of ProcellaRX interviews Avital Avitsur. Avital is the Co-Founder and Chief Business Officer at Validify, an innovative company helping regulated companies to automate the risk analysis and validation processes.
 
Avital is a CPA with experienced in mergers & acquisitions (M&A), financial accounting, securities regulation, transaction support and corporate finance. Strong sales professional with a master’s degree focused on international business, trade, and tax law.

Few years ago, Avital decided to pivot her career and use her vast knowledge in the Israeli hi-tech industry and started a partnership program in her former company. 3 years ago, a friend from her army service offered her to join "Validify" as a co-founder to bring her business and partnership experience, and since then she is a female entrepreneur that likes to share her journey with others to encourage other women to join the arena.

*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

Welcome to the first episode of Women Leading Validation!
 
Dori Gonzalez-Acevedo, CEO of ProcellaRX and host of Women Leading Validation Podcast interviews Madhavi Ganesan.  Recorded Live from KENX CSA Hybrid Training May 11-12, 2022.  For the past 20 years, Madhavi has supported her pharma and medical device clients assess their current quality landscapes to develop successful Computer Systems Validation and Computer Software Assurance transformation strategies. This includes working with cross-functional teams to develop solutions implementing critical thinking methodologies and risk-based strategies to simplify overly complicated CSV programs to minimize non-value work, cost, and improve overall delivery. She is a dynamic leader that is passionate about supporting 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