Welcome to the Women Leading Validation podcast, hosted by Dori Gonzalez-Acevedo, and produced in partnership between ProcellaRX and KENX.Our goal is to promote and advance the validation practice amongst women. This is a podcast for female professionals in the Life Sciences industry. Here, we are all about the trends and challenges of validation today. Each episode, we’ll bring you interviews from special guests and thought leaders; where we will explore all areas of validation from cleaning, process and equipment validation as well as computerized systems with leading subject matter experts. Our Mission to connect and support women leading validation to crest greater equality, increase access to support to lead and empower women in all levels and roles within health and life sciences.
Maps, Mentors, and Learning: Professional and Personal Journeys, with Pratiksha Parekh
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, p...
21 Jul 2023
Improving Quality in Life Sciences and Beyond, with Rucha Patel
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...
23 Jun 2023
All Things Quality, with Kimberly Wallbank
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 t...
19 May 2023
Bringing out the Best, with Jillian Mantua
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 ...
31 Mar 2023
A Journey of Progress, Preservation, and Innovation, with Dr. Sue Black
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 o...
3 Feb 2023
Women Leading Validation Spotlight: Wendy Haines - Continuous Learning and Professional Societies
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 contac...
13 Jan 2023
Women Leading Validation Spotlight: Katie Terry - Culture of Learning
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...
15 Dec 2022
Women Leading Validation Spotlight: Double Episode with Connie Hetzler and Lisa Sykes-Winstead
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 Univer...
18 Nov 2022
Women Leading Validation Spotlight: Krisha Patel and Tanya Sharma - Driving Impactful Change
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 ...
14 Oct 2022
Women Leading Validation Spotlight: Denise Dajles - Quality Leadership
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 M...
23 Sept 2022
Women Leading Validation Spotlight: Avital Avitsur Business Development and Entrepreneur
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...
2 Sept 2022
Women Leading Validation Spotlight: Ann Vu - Quality & Regulatory Leader
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 busine...
1 Jul 2022
Women Leading Validation Spotlight: Madhavi Ganesan - CSV Strategic Advisor
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 include...
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