Life Sciences 360 is an interview show that educates anyone on challenges, trends, and insights in the life-sciences industry. Hosted by Harsh Thakkar, a life-sciences industry veteran and CEO and co-founder of Qualtivate, the show features subject-matter experts, business leaders, and key life-science partners contributing to bringing new therapies to patients worldwide. Harsh is passionate about advancements in life sciences and tech and is always eager to learn from his guests— making the ...
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In-depth analysis and breakdown of songs. This podcast would take a deeper look at the songs we love and listen to on a regular basis. Join me on this beautiful journey of exploring the depth of songs.
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The Punishers are a wheelchair basketball team based in Washington, D.C. These are their stories.
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How DoseMeRx is Transforming Patient Care
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Welcome to episode 048 of Life Sciences 360. In this episode, Sharmeen discuss the current one-size-fits-all approach in healthcare and the need for precision dosing. Sharmeen explains how DoseMe platform simplifies complex dosing methods at the bedside, benefiting both clinicians and patients. Sharmeen also touch on the integration with electronic…
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How InVision helps you make drug development decisions? #lifesciences
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Welcome to episode 047 of Life Sciences 360. In this video, We discuss the importance of using AI in decision making in the life sciences industry. Ben highlight the need for evidence-based decision making and the challenges of finding relevant information in a sea of data. Ben introduce InVision, a platform that helps biotech and pharma companies …
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How CTMC is Changing Medicine Manufacturing
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Welcome to episode 046 of Life Sciences 360. On this episode, Harsh discuss the intersection of luck and preparation in finding opportunities, particularly in the field of cell therapy. Harsh share insights from his conversation with Dr. Jason Bock, founder and CEO of CTMC, about the advancements and challenges in autologous cell therapies. We delv…
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AI in Life Sciences: Should You Follow This Trend?
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Welcome to episode 045 of Life Sciences 360. On this episode, Nagesh Nama and his team at XLM talk on why Gen.AI is essential in the software test world and share examples of its use in various industries, particularly in life sciences and manufacturing. They address the challenges faced by companies in adopting AI and provide solutions for integra…
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The NASA Scientist Who Changed Cancer Diagnostics Forever
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Dr. Arnon Chait, CEO of Cleveland Diagnostics, discusses his transition from NASA to the healthcare innovation space and the development of cancer diagnostics. Dr. Chait emphasizes the importance of using diagnostic advancements to strike a balance between over-screening and under-treating, particularly in the workup of cancer after failed screenin…
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How On-Demand Cleanrooms Can Speed Up Drug Development
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With the market estimated to reach $11.5 billion by 2028. Clean Rooms on Demand is providing flexible and cost-effective solutions for biotech and pharma companies. The benefits of using clean rooms on demand include avoiding the high capital outlay and ongoing operational expenses of building and maintaining their own facilities, as well as the fl…
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Beyond the Pill: When Medicine Meets Mindset with CEO, Will Hind
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How can behavioral science optimize pharmaceutical practices? Episode 042: Will Hind, CEO of Alpharmaxim Healthcare Communications, discusses the challenges and opportunities in integrating behavioral science with pharma strategies. Find out how this can lead to better patient outcomes and more tailored healthcare solutions. ----- Links: *Will Hind…
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The 3 Most Important Pillars of a Next-Generation CDMO, Explained!
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Episode 041: J.D. Mowery, President and CEO of KBI Biopharma, discusses his career journey and the role of CDMOs in the biotech and pharma industry. He emphasizes the importance of relationships, risk-taking, and continuous learning in his career success. J.D. highlights the unique combination of expertise required to work in both biotech and CDMO …
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Use This Tech, Transform Science: Flow Meters w/ Bethany Silva
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Are you interested in how the latest flow technology is transforming biopharmaceutical manufacturing? Join us for Episode 40 of the Life Sciences 360 podcast, where Harsh Thakkar (@harshvthakkar), CEO of Qualtivate sits down with Bethany Silva (@bethany-silva), Life Sciences Industry Manager at Endress+Hauser. They delve deep into the world of flow…
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Democratizing Cell Therapy: A PhD's Quest to Change Medicine Forever
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Toon Lambrechts, co-founder of MyCellHub, shares his journey in democratizing access to cell and gene therapy. He discusses the challenges in cell therapy manufacturing, including the high costs and complex logistics. MyCellHub aims to reduce manufacturing costs and automate processes to make cell therapies more affordable and accessible. Toon emph…
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No Vision, No Problem: How Aaron Golub Redefined Possible
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Aaron Golub, a consultant and speaker, shares his story of overcoming adversity as a legally blind athlete and ex-NFL free agent. He discusses his journey from being a third-string high school athlete to becoming the first legally blind Division I athlete. Aaron also talks about his transition from sports to a career in finance and eventually to co…
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His Strategy and Success Story with the MedTech Startup: FastWave
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He scaled his business from 0 to 20 million in under 3 years. Get inspired by the story of Scott Nelson's strategic brilliance and entrepreneurial triumph with Joovv and FastWave Medical, a groundbreaking MedTech startup reshaping the industry landscape. Learn about the strategic decisions, challenges overcome, and pivotal moments that defined Scot…
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How SHE is Improving Patient Care with AI Enhanced Medical Devices
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Weronika discusses the importance of integrating software with other systems for success and touches on various challenges such as data integration, user needs, and documentation practices. She highlights the evolving role of AI and software in healthcare, emphasizing patient-centered solutions and the importance of continuous learning in the Med-T…
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Employee Mental Health is VITAL to Success in ANY Business
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Heather talks about the role of art in quality and documentation, challenges with document control methods, and her experience writing an article for Quality Magazine. She shares advice for entering the life sciences industry and the role of mentors in career development. Harsh and Heather also address the importance of mental health for leaders, t…
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Why Quality Assurance is More Than Just Following the Rules with Kimberly Wallbank
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Episode 034: Harsh Thakkar (@harshvthakkar) interviews Kimberly Wallbank (@kimberlywallbank), the Principal Consultant at Quality Systems Services, LLC. Kimberly addresses the evolution of quality and regulatory practices, particularly the increased focus on risk assessment. She discusses the challenges companies face with compliance and the need f…
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The Intersection of Science and Art: How Chijindu is Bridging the Gap
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Episode 033: Harsh Thakkar (@harshvthakkar) interviews Chijindu E. O. (@chijindu-authorceco), the Founder & Creative Director of Ceco Creations. Chijindu shares his journey in the field of science and art, starting with creating cartoons and animations to inspire and educate people, noting that visual appeal and creativity can make scientific conte…
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Data, Decisions, and AI: The Power of Analytics in Life Sciences with Elizabeth Smalley
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Episode 032: Harsh Thakkar (@harshvthakkar) interviews Elizabeth Smalley (@elizabeth-smalley-product-leader), the Director of Product Management, Data and Analytics at Aris Global. Elizabeth discusses proactive safety signal detection in the context of drug development and the challenges faced in this space. She highlights the importance of utilizi…
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Building a Five Star Career: Tips from Quality Management Pro, Penelope Przekop
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Episode 031: Harsh Thakkar (@harshvthakkar) interviews Penelope Przekop (@penelopeprzekop), the CEO at PDC Pharma Strategy and author of the book 'Five Star Career.' Penelope discusses her background in the pharmaceutical industry and the importance of quality management. She provides practical advice on collaboration, continuous learning, and find…
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Unveiling AI’s Impact on Life Sciences Regulation with Ivan Perez Chamorro
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Episode 030: Harsh Thakkar (@harshvthakkar) interviews Ivan Perez Chamorro (@ivan-perez-chamorro) the CEO and Founder of MedBoard. Ivan shares the inspiration behind starting MedBoard. He recognized the need for a platform that provides access to trusted information in the life sciences industry. He describes how AI is integrated into MedBoard to a…
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The Future of Women’s Health: Insights From Bethany Corbin
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Episode 029: Harsh Thakkar (@harshvthakkar) interviews Bethany Corbin (@bethanycorbin), the Co-Founder of FEMInnovation and Managing Partner at Women's Health Innovation Consulting. Bethany shares her journey, going from law studies to founding FEM Innovation, focusing on improving reproductive health for women. She talks about the challenges women…
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The Surprising Link Between Technology and Mental Health: A Conversation with Dr. Cortney Warren
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Episode 028: Harsh Thakkar (@harshvthakkar) interviews Dr. Cortney Warren (@drcortney), a Clinical Psychologist and the Founder and Owner of Choose Honesty LLC. Dr. Cortney emphasizes the need for mindfulness regarding our technology usage and its effects on our mental health. She also delves into the importance of being truthful about our struggle…
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Staying Compliant in a Changing World: Best Practices with Niyati Patel
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Episode 027: Harsh Thakkar (@harshvthakkar) interviews Niyati Patel (@niyatipatel), the Director of Quality Engineering at Getinge (Maquet Cardiovascular) and a Sr. Regulatory/ Quality Consultant at Compliance Insight, Inc. Niyati breaks down the complexities of quality management systems, compliance, and regulations in the industry. She discusses …
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Mastering Quality & Regulation Across Continents With John McKay
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Episode 026: Harsh Thakkar (@harshvthakkar) interviews John McKay (@johnlmckay), President, Chief Operating, Quality & Regulatory Affairs Officer at Q1 Associates LLC. John emphasizes the critical role of quality plans in ensuring error prevention and maintaining top-notch quality in the life sciences industry. The conversation takes a global persp…
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Innovation in Healthcare: How to Stay Ahead of the Curve With Kamya Elawadhi
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Episode 025: Harsh Thakkar (@harshvthakkar) interviews Kamya Elawadhi (@kamya_elawadhi), SVP of Platform and Corporate Strategy at Doceree. Kamya shares her wealth of experience in healthcare advertising and innovation, bridging the challenges and opportunities of navigating regulatory environments and leading in the healthcare advertising industry…
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Digital Therapeutics Explained with Richard ‘RJ’ Kedziora
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Episode 024: Harsh Thakkar (@harshvthakkar) engages in a riveting discussion with RJ Kedziora (@RJKedziora), Co-Founder / Partner and Solutions Architect Estenda Solutions, Inc. In this episode, RJ uncovers the ins and outs of blending clinical information with imaging data, especially for patients with chronic conditions like diabetes and hyperten…
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Balancing Compliance and Innovation in Risk Management: A Discussion with Naveen Agarwal
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Episode 023: Harsh Thakkar (@harshvthakkar) interviews Naveen Agarwal (@naveenagarwal), the Principal and Founder of Creative Analytics Solutions, LLC. Naveen highlights the importance of aligning risk management with innovation and patient well-being, contrasting it with compliance-focused approaches. He also addresses evaluating team risk appetit…
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Paperless Validation: Breaking Through Industry Barriers with Andy Robinson
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Episode 022: Harsh Thakkar (@harshvthakkar) interviews Andy Robinson (@andyrobinson2), Founder & CEO at GxPaaS. Andy discusses the importance of customer discovery when creating a new product and shares his experience with creating a questionnaire to gain feedback from potential customers. He also talks about the challenges of transitioning from pa…
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Personal Branding and Consulting in the Medical Device Industry with Monir El Azzouzi
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Episode 021: Harsh Thakkar (@harshvthakkar) interviews Monir El Azzouzi (@melazzouzi), Founder & CEO at Easy Medical Device. Monir emphasizes the importance of following people in the medical device industry, learning as much as possible, and providing the right vocabulary and language to build self-confidence. Monir also shares his favorite Linked…
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The Thin Line Between Advertising and Misbranding with Darshan Kulkarni
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Episode 020: Harsh Thakkar (@harshvthakkar) interviews Darshan Kulkarni (@darshankulkarni), Regulatory and Compliance Attorney at The Kulkarni Law Firm. Darshan talks about the importance of understanding how to use AI properly. He also discusses his work in advertising compliance, which involves ensuring that companies meet the labeling requiremen…
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Continuous Validation: The Key to Successful Life Sciences Software with Nagesh Nama
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Episode 019: Harsh Thakkar (@harshvthakkar) interviews Nagesh Nama (@nageshnama), the Chief Executive Officer at xLM. Nagesh shares his perspective on continuous validation and emphasizes the unique capabilities of his platform, which includes the generation of digitally signed PDF reports. Harsh and Nagesh discuss xLM's platform and its approach t…
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The Intersection of Theory and Practice in Quality Management: Perspectives from Amy Wilson and Cliff Berry
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Episode 018: Harsh Thakkar (@harshvthakkar) interviews Amy Wilson (@amydwilson) and Cliff Berry (@cliffordberry), co-authors of the book Do Quality Differently, a playbook for creating more success in biopharma (or any) manufacturing. Amy Wilson and Cliff Berry explore the concepts of the black line and blue line, underscoring the importance of dis…
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The Promise and Perils of Large Language Models in Healthcare and AI-based Software as a Medical Device with Vivek Thakkar
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Episode 017: Harsh Thakkar (@harshvthakkar) interviews Vivek Thakkar (@vivekbthakkar), the Senior Digital Health Consultant at Biologics Consulting Vivek emphasizes the importance of validating AI-based software in clinical settings to ensure safety and efficacy. He also discusses the challenges of continuous improvement in algorithms and the need …
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Role of AI in Talent Recruitment and Consulting vs. Employment Takeaways with Dharti Pancholi
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Episode 016: Harsh Thakkar (@harshvthakkar) interviews Dharti Pancholi (@dhartipancholi), the Founder and Chief Executive Officer at Omni Consulting Services Dharti discusses her journey in starting her own consulting firm, her experience in both consulting and user-side companies, and her thoughts on recruitment and AI technology. Harsh and Dharti…
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The Promising and Perilous Potential of AI in Life Sciences: A Discussion with Greg Hutchins
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Episode 015: Harsh Thakkar (@harshvthakkar) interviews Greg Hutchins (@greghutchins), the Founder of Quality + Engineering and Founder & Director of Certified Enterprise Risk Manager® (CERM) Academy. Greg Hutchins provides examples of unintended bias in AI systems and the challenge of monitoring and managing AI systems to ensure that they are fair,…
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Investing in Early-Stage Startups: A Personal Perspective with Giovanni Lauricella
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Episode 014: Harsh Thakkar (@harshvthakkar) interviews Giovanni Lauricella (@giovannilauricella), the Co-Founder & Managing Partner at Lifeblood Capital and Board Member & Investor at Vivifi Medical. Giovanni emphasizes the need for entrepreneurs to understand their audience and to have a viable product that solves a problem. He also stresses the i…
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Goodbye Cumbersome Searches, Hello Smart Regulatory Intelligence With Marcus Emne
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Episode 013: Harsh Thakkar (@harshvthakkar) interviews Marcus Emne (@marcusemne), the Chief Executive Officer at Hoodin. Marcus explains how Hoodin's platform helps users gather specific data by monitoring keywords, regulations, and standards from selected sources. He also mentions the importance of AI in the industry and how it can help profession…
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The Benefits of Conversation-Based Training in the Medical Industry: Insights from Quality Expert Aaron Snyder
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Episode 012: Harsh Thakkar (@harshvthakkar) interviews Aaron Snyder (@aaron-snyder-mscgmp), the Head of Quality at Fresenius Kabi and a lead faculty and trainer for FDA and industry professionals at AAMI. Aaron touches on the challenges of making regulatory training engaging and interesting, and the importance of understanding the difference betwee…
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The Power of Video and Personalization in Recruitment: Insights from Mitch Robbins
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Episode 011: Harsh Thakkar (@harshvthakkar) interviews Mitch Robbins (@mitchrobbins), the founder and managing director of Anthony Michael Group. Mitch shares insights on how to rise above the noise and get noticed by hiring managers, as well as tips for candidates on how to differentiate themselves and add value to their job search. Harsh and Mitc…
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Importance of Plain Language in QA Documentation and Having the Right Mindset With Kathy Walsh
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Episode 010: Harsh Thakkar (@harshvthakkar) interviews Kathy Walsh (@drkathywalsh), the managing director and principal consultant at Quality Systems Now. Kathy Walsh shares her experience working with clients to build and design effective quality management systems (QMS) and stresses the importance of integrating QMS into daily operations. Harsh a…
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The Future of Quality Management Systems and Building a Community With Etienne Nichols
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Episode 009: Harsh Thakkar (@harshvthakkar) interviews Etienne Nichols (@etiennenichols), the medical device guru and community manager at Green Light Guru. Etienne shares his background in engineering, including his experience in the aerospace, steel manufacturing, and aircraft interior industries. Harsh and Etienne discuss how Quality Management …
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How to Hire Quality Assurance (QA) Talent and Tips for Job-Seekers Looking For QA Roles With Hemish Ilangaratne
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Episode 008: Harsh Thakkar (@harshvthakkar) interviews Hemish Ilangaratne (@hemish-ilangaratne), the founder of Rx-Group.io, a recruitment firm focused on the quality assurance space in the US and Europe. In this episode, Hemish shares his insights on building a company culture around quality, the importance of references in job applications, and t…
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Conditioned Bias around Quality and How to Do a Quality Culture Assessment With Antiksha Joshi
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Episode 007: Harsh Thakkar (@harshvthakkar) interviews Antiksha Joshi (@antikshajoshi), Director of Urmi Quality Management Consulting (UQMC). Antiksha discusses the importance of quality culture assessments and how they can improve quality assurance in the life sciences industry. Antiksha also shares her perspective on common misconceptions about …
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Quality Management Evolution: From Inspection to Discovery With Nicole Radziwill
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Episode 006: Harsh Thakkar (@harshvthakkar) interviews Nicole Radziwill (@nicoleradziwill), SVP and Chief Data Scientist at Ultranauts Inc, an onshore software & data quality engineering services firm powered by cognitively diverse teams. Nicole is also the author of Connected, Intelligent, Automated: The Definitive Guide to Digital Transformation …
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Take On FDA Computer Software Assurance (CSA) Guidance, Tips for Managing SaaS Releases, and Hiring Top Talent With Rohit Tyagi
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Episode 005: Harsh Thakkar (@harshvthakkar) interviews Rohit Tyagi (@rohittyagi7), President of Sagax Team. Rohit shares his transition from working in life sciences companies to building Sagax Team as a quality assurance and lab informatics consulting practice with 50+ consultants. Rohit and Harsh discuss common mistakes life science companies mak…
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The Power of Clear Communication, 3 Writing Tips, and Creating a Quality Culture With Lesley Worthington
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Episode 004: Harsh Thakkar (@harshvthakkar) interviews Lesley Worthington (@lesleyworthington), Communication and Writing Coach for Quality Assurance Professionals. Lesley shares her journey from working as a QA professional to becoming a writing and communication coach. Lesley deep dives into the problem of writing in the real world and 3 tips to …
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From Working as a Process Engineer at a Mining Company to Building a No-Code Platform for Life Sciences With Vivek Gera
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Episode 003: Harsh Thakkar (@harshvthakkar) interviews Vivek Gera (@vivekgera), Co-Founder and CEO at Leucine.io, a no-code platform for fast and compliant drug manufacturing. Vivek talks about how he came up with the idea of Leucine, the challenges of running a tech company serving life science customers, and the phases life science companies can …
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Why GMP Learning Is a Snoozefest, QA Audit Stories, and Building Your Personal Brand With Yan Kugel
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Episode 002: Harsh Thakkar (@harshvthakkar) interviews Yan Kugel (@yankugel), Managing Director at Qualistery. Yan shares his purpose behind Qualistery, tips to make GMP learning materials more engaging, his approach to conducting QA audits, and advice on how life science thought leaders could share knowledge to stand out on social media and build …
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Royal Air Force, Elephant in the Med-Tech Room, and LinkedIn Creator Accelerator Program With Karandeep Singh Badwal
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Episode 001: Harsh Thakkar (@harshvthakkar) interviews Karandeep Badwal (@karandeepbadwal), a MedTech expert, founder of QRA Medical, and host of the MedTech podcast. Karandeep shares insights on how med-tech companies can keep up with regulatory changes, his time at Royal Air Force in his teenage years, and his experience with LinkedIn's Creator A…
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Ek Tukda Dhoop is the expression of Amrita's sadness and pain after she realizes how her marriage was far from perfect. This episode tries to connect the lines to her feelings and how each of the lines represents a feeling of hers. Tune in to hear this perspective in detail. Blog Version- https://perceptivecolors.wordpress.com/2022/02/25/ek-tukda-d…
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Tum Saath Ho is a wonderful song that talks about the sadness that is ingrained in Ved's life. Look at it and Tara becomes the heart that wants to follow the inner calling while Ved is the brain that chooses to take the path that society and his father have conditioned him to. Tune in to hear this perspective in detail. Blog Version- https://percep…
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