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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 he shares 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 he shares 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
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