Qualistery - GMP Content
Qualistery - GMP Content
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Risks and Rewards in GMP Process Automation [Will Moss] #77
In this episode, Yan Kugel is joined by Will Moss founder and CEO of Seal, to talk about the critical need for automation in GXP processes. Will shares his expertise on balancing automation with human oversight, addressing data privacy concerns, and the future of quality management in the pharmaceutical sector.
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มุมมอง: 24

วีดีโอ

Navigating Workplace Dynamics as a Woman in Leadership- Christy Mazzarisi #76
มุมมอง 19หลายเดือนก่อน
In this episode, Yan Kugel is joined by Christy Mazzarisi, a distinguished leader in the pharmaceutical industry with extensive experience in quality systems and leadership roles. In this episode, we explore Christy's journey in pharma, her works, her impact on advocacy and leadership, and her vision for empowering women in the pharmaceutical industry. Subscribe to The Qualitalks Podcast with y...
Pharma Trends: The Return of the FDA Warning Letters - Simone Ammons - #75
มุมมอง 91หลายเดือนก่อน
In this episode, Yan Kugel is joined by Simone Ammons, a dynamic engineer, technical writer, and entrepreneur who has navigated through diverse industries with finesse. She's the founder of the QneUp, a data-driven software tool that reduces equipment downtime and boosts productivity in the pharmaceutical industry. In this episode, we will be discussing data and FDA warning letters trends acros...
The Impact of AI on Patent Research and Analysis in the Pharma [Ben Coverdale] #74
มุมมอง 33หลายเดือนก่อน
In this episode, Yan Kugel is joined by Ben Coverdale, PhD, a seasoned global account director at Patsnap with a strong background in the life sciences and innovation and intelligence sectors. Ben brings a wealth of experience and insights into how AI and LLMs (Large Language Models) are transforming patent research and analysis in the pharmaceutical industry. Subscribe to The Qualitalks Podcas...
Navigating Complexity: Challenges and Solutions in Pharma 4.0 [Pavan Pasupulati] #73
มุมมอง 28หลายเดือนก่อน
In this episode, Yan Kugel is joined by Pavan Pasupulati, the Vice President of Manufacturing Excellence at Caliber Technologies. Here, he shares valuable insights into the future of pharmaceutical manufacturing. With over 25 years of experience in both the process and IT industries, Pavan has become a key figure in driving digital transformation within pharmaceutical manufacturing. Subscribe t...
Navigating FDA Inspections: Things You Should Never Say! [Vincent F. Cafiso] #72
มุมมอง 65หลายเดือนก่อน
In this episode, Yan Kugel is joined by Vincent Cafiso, the Director of Quality and Regulatory Services at CREO Consultancy and a former FDA investigator. Vincent shares invaluable advice on things never to say to an FDA investigator based on his extensive experience and expertise in the field. Join us as we uncover essential strategies and best practices to navigate FDA inspections with profes...
The Strategic Journey of Pharmaceutical Commercialization [Mohamed Amer] - #71
มุมมอง 142 หลายเดือนก่อน
In this episode, Yan Kugel is joined by Mohamed Amer, a seasoned executive with over 20 years of experience in strategic and commercial leadership in the healthcare industry. Mohamed emphasizes the significance of CME (Continuing Medical Education) accreditation when promoting pharmaceutical products. He further discusses the challenges companies face in different countries regarding ethical st...
Improving Processes: Insights and Transitions [Kelly Stanton] #70
มุมมอง 352 หลายเดือนก่อน
In this episode, Yan Kugel is joined by ⁠Kelly Stanton⁠, the Head of Quality Systems Improvement at Corden Pharma. Kelly discusses her transition back to the pharmaceutical industry after four years at Qualio, an eQMS provider. She also shares her improvement projects that make a real difference in her organization. Additionally, she shares insights on improving processes, the importance of reg...
Revolutionizing Validation and Automation in Biotech [Nagesh Nama] - #69
มุมมอง 1042 หลายเดือนก่อน
Yan Kugel⁠ is joined by Nagesh Nama, CEO at xLM who brings a wealth of experience and expertise in incorporating AI into validated processes within the pharmaceutical industry. Nagesh shares insights on the benefit challenges and best practices of using AI and machine learning technologies in pharmaceutical manufacturing quality. His insights shed light on the challenges and solutions in implem...
Navigating Communication Challenges in Quality-Driven Environments [Lesley Worthington] #68
มุมมอง 1262 หลายเดือนก่อน
Yan Kugel⁠ is joined by Lesley Worthington, a communication and leadership coach for quality professionals. Together, they discussed the significance of interpersonal skills in the realm of quality assurance within the pharmaceutical industry. Lesley emphasizes that communication and interpersonal skills are often overlooked but are crucial for quality professionals. Technical knowledge is impo...
Experimenting with AI in Pharma: A Question of Time [Vasyl Chumachenko] #66
มุมมอง 523 หลายเดือนก่อน
Yan Kugel⁠ is joined by Vasyl Chumachenko, Head of AI Consulting at Data Science UA. Here they delve into the future of pharma and explore the intersection of AI, ML, and GMP compliance. With a wealth of experience in integrating AI solutions into chemical and pharmaceuticals, Vasyl brings a unique perspective on driving innovation and growth in the industry. Together they explore the prospects...
Enhancing Compliance and Efficiency in Pharma Manufacturing with AI [Vivek Gera] #65
มุมมอง 753 หลายเดือนก่อน
Yan Kugel⁠ is joined by Vivek Gera, the CEO of Leucine and a seasoned process engineer. Vivek has a wealth of experience leveraging cutting-edge technologies to enhance compliance and operational efficiency within pharmaceutical manufacturing. Throughout this episode, they delve into the transformative impact of AI on manufacturing, QA, and QC processes, shedding light on how these advancements...
Revolutionizing Temperature Control in Pharma [Jakob Konradsen] #64
มุมมอง 593 หลายเดือนก่อน
Yan Kugel⁠ is joined by Jakob Konradsen, the Co-Founder & Head of Quality at Eupry and here he discusses the importance of moving away from paper or PDF calibration certificates and manual work in the GXP industry. They explore the idea of using machine learning algorithms for auditing and the need for a business continuity plan for temperature control. The speaker emphasizes the value of being...
How to Navigate GDP Compliance in Pharma [Paul Sarrazin] #63
มุมมอง 473 หลายเดือนก่อน
Yan Kugel⁠ is joined by Paul Sarrazin, an esteemed expert in good distribution practices (GDP) within the pharmaceutical sector. Here, he provides a glimpse into his journey from a permanent employee to a consultant specializing in GDP compliance. With a strong background in bioengineering and a rich portfolio of collaborations with industry giants like GSK, UCB, and Takeda, Paul's expertise in...
Navigating the World of Asset Management and Quality Assurance [Jennifer Chang]
มุมมอง 354 หลายเดือนก่อน
Yan Kugel is joined by Jennifer Chang, a QA Intelligence Specialist at Blue Mountain. Yan and Jennifer discuss the impact of digital transformation on manufacturing processes, the challenges and benefits of compliance in the pharmaceutical industry, and companies' struggles in keeping up with regulators and taking a risk-based approach. They also explore why companies switch to digitized soluti...
Unleashing the Power of AI in Pharma [Fabrizio Maniglio] #61
มุมมอง 714 หลายเดือนก่อน
Unleashing the Power of AI in Pharma [Fabrizio Maniglio] #61
Navigating the Path to Success A Journey into Consulting in the Life Sciences [Harsh Thakkar] #60
มุมมอง 284 หลายเดือนก่อน
Navigating the Path to Success A Journey into Consulting in the Life Sciences [Harsh Thakkar] #60
Empowering Pharma Partnerships with Digitalization [Ammar Badwy] #59
มุมมอง 204 หลายเดือนก่อน
Empowering Pharma Partnerships with Digitalization [Ammar Badwy] #59
Explore the Future of APQR: Revealing the Influence of Digital Tech on Pharma Quality Reviews.
มุมมอง 7911 หลายเดือนก่อน
Explore the Future of APQR: Revealing the Influence of Digital Tech on Pharma Quality Reviews.
Mastering Pharma Temperature Monitoring: 5 Tips for Seamless Automation
มุมมอง 3211 หลายเดือนก่อน
Mastering Pharma Temperature Monitoring: 5 Tips for Seamless Automation
Securing Quality in Pharma: How Thermal Mapping Makes the Difference
มุมมอง 67ปีที่แล้ว
Securing Quality in Pharma: How Thermal Mapping Makes the Difference
Practical Steps to Excellence: Mastering Risk Management in Pharmaceuticals with a Case Study
มุมมอง 43ปีที่แล้ว
Practical Steps to Excellence: Mastering Risk Management in Pharmaceuticals with a Case Study
Conquer Pharma Audits: 4 more tips to elevate your skills
มุมมอง 58ปีที่แล้ว
Conquer Pharma Audits: 4 more tips to elevate your skills
Improving Manufacturing Efficiency and Compliance with Toon Lambrechts [The Qualitalks Podcast[
มุมมอง 94ปีที่แล้ว
Improving Manufacturing Efficiency and Compliance with Toon Lambrechts [The Qualitalks Podcast[
From Audit Stress to Success: Overcoming the 6 Common Challenges
มุมมอง 68ปีที่แล้ว
From Audit Stress to Success: Overcoming the 6 Common Challenges
Mastering the Art of Calibration: 6 Factors for Selecting Perfect Calibration Points
มุมมอง 30ปีที่แล้ว
Mastering the Art of Calibration: 6 Factors for Selecting Perfect Calibration Points
Reliable access to medications: Best Practices to Mitigate Disruptions in Drug Manufacturing
มุมมอง 21ปีที่แล้ว
Reliable access to medications: Best Practices to Mitigate Disruptions in Drug Manufacturing
The 4 Technologies That Will Increase Reliability and Compliance in Life Science Manufacturing
มุมมอง 15ปีที่แล้ว
The 4 Technologies That Will Increase Reliability and Compliance in Life Science Manufacturing
What Cold Chain Solutions Are There and How to Monitor Them [Nathan Roman]
มุมมอง 74ปีที่แล้ว
What Cold Chain Solutions Are There and How to Monitor Them [Nathan Roman]
Temperature Mapping - All You Need To Know About Good Qualification Protocol [Nathan Roman]
มุมมอง 131ปีที่แล้ว
Temperature Mapping - All You Need To Know About Good Qualification Protocol [Nathan Roman]

ความคิดเห็น

  • @NahidMojumder-u1y
    @NahidMojumder-u1y หลายเดือนก่อน

    Appreciate this video a ton!

  • @wld-ph
    @wld-ph หลายเดือนก่อน

    FDA is playing catch-up with inspections, widening gaze, just like everyone else.

  • @vincentcafiso3855
    @vincentcafiso3855 2 หลายเดือนก่อน

    Great conversation Yan! I really enjoyed speaking with you on this VERY IMPORTANT topic!

  • @gingerjones111
    @gingerjones111 2 หลายเดือนก่อน

    If they refuse to speak with you on the phone, they are not serious. I disagree about LinkedIn, you can look at it but that doesn't mean it needs to be the primary port of call. LinkedIn is filled with liars, so I don't take it seriously when I am hiring.

  • @xaviermbida7005
    @xaviermbida7005 2 หลายเดือนก่อน

    Amazing video! Thanks for your work!

  • @ratkapr684
    @ratkapr684 3 หลายเดือนก่อน

    I’m a process engineer graduate in Germany with a Masters degree. I have problem in getting a job and I want to transit to Pharma , what certification do i need to?

  • @PABPbb
    @PABPbb 4 หลายเดือนก่อน

    Excellent video!, thank you!

  • @memoriesatlast
    @memoriesatlast 5 หลายเดือนก่อน

    I am looking for pointers on drying a floor using a caution cone with a fan

  • @catherinebrench2195
    @catherinebrench2195 5 หลายเดือนก่อน

    I am starting up as a Foot Health Practioner, going to buy an Autoclave with a basket. As I am only going to do part-time work, also they are smaller and less expensive. Looking at Prestige autoclave-model 210052. Can you use sterilization pouches for instruments in this type of autoclave? Hope to hear from you..

  • @vajona2495
    @vajona2495 9 หลายเดือนก่อน

    Imagine believing this nonsense. You didn't get hired because they are not hiring based on merit; rather they are hiring Affirmative Action Trash, like the thing in this video

  • @tiend3220
    @tiend3220 10 หลายเดือนก่อน

    I enjoyed the content. Found it today. Thank you!

  • @alexandergreene3234
    @alexandergreene3234 11 หลายเดือนก่อน

    Promo`SM 😻

  • @beontrack7366
    @beontrack7366 ปีที่แล้ว

    How much percentage does a contractor roughly earn more than a permanent employee?

  • @ProfessionalFilmmakers
    @ProfessionalFilmmakers ปีที่แล้ว

    The things is: LinkedIn's algorithm will punish you for adding people you don't know. You should only add people you work with or know in some way. There is a little button someone clicks that says "I don't know this person" after they ignore your friend request. If enough people click that button LinkedIn shadow bans you without your knowing it. Also, adding people just because they're in the same industry won't help you on LinkedIn. That only works on Facebook or Twittter. Maybe Instagram.

  • @liseaimejaychou
    @liseaimejaychou ปีที่แล้ว

    Hello, I want to know if the machine capability study is mandatory in the qualification processus? If yes, it is part of OQ or PQ? Thanks

  • @sudo_nym
    @sudo_nym ปีที่แล้ว

    I worked with Kris at GE in Amersham some years back. Great guy!

  • @MP-dz2ki
    @MP-dz2ki ปีที่แล้ว

    so valuable! thank you!

    • @Qualistery
      @Qualistery ปีที่แล้ว

      Glad it was helpful!

  • @cmtmuthu8290
    @cmtmuthu8290 ปีที่แล้ว

    Will anyone explain about 21CFR??

  • @CebiGreen
    @CebiGreen ปีที่แล้ว

    Very insightful especially from a different region. How does one prepare herself to land a consulting job in Swiss? Any chance to get transferred from US to Swiss?

  • @redica-systems
    @redica-systems ปีที่แล้ว

    So good to see Jerry on your show! 🙌

  • @sabryalshazly2553
    @sabryalshazly2553 2 ปีที่แล้ว

    thanks so much,🌹🥀🌺 great

    • @Qualistery
      @Qualistery ปีที่แล้ว

      Most welcome 😊

  • @gxpmatters5705
    @gxpmatters5705 2 ปีที่แล้ว

    th-cam.com/channels/yB3GFq6cWuAZzGWpnTX70A.html

  • @christinmathew67
    @christinmathew67 2 ปีที่แล้ว

    Thank You

  • @yutingwu4875
    @yutingwu4875 2 ปีที่แล้ว

    Memerlukan lebih ramai orang jadi sebarkan video ini lebih banyak

  • @SouthAfricanCannabisExtraction
    @SouthAfricanCannabisExtraction 2 ปีที่แล้ว

    Great discussion topic 👍

  • @elenadenisova2251
    @elenadenisova2251 2 ปีที่แล้ว

    Super!

  • @heenapatel5973
    @heenapatel5973 2 ปีที่แล้ว

    really nice explaination

  • @myintmyintthan5833
    @myintmyintthan5833 2 ปีที่แล้ว

    Great

  • @TJ-hq7ib
    @TJ-hq7ib 2 ปีที่แล้ว

    당신은 매우 아름다운 이미지를 만들고 Nghia Tui는 그것을 정말 좋아합니다.

  • @maxyoung7082
    @maxyoung7082 2 ปีที่แล้ว

    so touching for an excellent video

  • @deepbist5064
    @deepbist5064 2 ปีที่แล้ว

    To what extent and how would you validate the cloud services and maintain the system in a validated state in a scenario where cloud vendor updates cloud codes as part of its maintenance release?

  • @SouthAfricanCannabisExtraction
    @SouthAfricanCannabisExtraction 2 ปีที่แล้ว

    Great interview, keep up these great discussions!

  • @thithuynguyen5158
    @thithuynguyen5158 2 ปีที่แล้ว

    so touching for an excellent video

  • @frominside8223
    @frominside8223 2 ปีที่แล้ว

    Many thanks for this content Sir. What kind of tools are there for a project engineer (studied Process engineering) in biotech to develop himself?

  • @frominside8223
    @frominside8223 2 ปีที่แล้ว

    Thank you very much for this video. What are the typical equipments, apparatus, maschines etc in biopharma project planning? Are there any sources where I can see an P&I Diagrams, flow charts etc...?

  • @frominside8223
    @frominside8223 2 ปีที่แล้ว

    Many thanks!

  • @huytrinh432
    @huytrinh432 2 ปีที่แล้ว

    so touching for an excellent video

  • @MUHAMMADHAZRIZALBINMUKHTAR
    @MUHAMMADHAZRIZALBINMUKHTAR 2 ปีที่แล้ว

    great explanation.. its help me a lot

  • @gaborlantos4041
    @gaborlantos4041 2 ปีที่แล้ว

    I'm a quality expert working in automotive, not in healthcare. I fully agree with the statemetn of the auditor. Maybe I didn't listen to the video carefully, but I miss several things. So first of all I would stop the production! Second I would have forced the audited organisation to start a detailed risk analysis about what are the potential effects of the impurities to the consumers, how many products are distributed to the market already, exactly where, and I would have asked them to make an approximate cost estimation of a potential recall. As well I would request an immediate communication strategy towards the public.

  • @HuyenBui-xu7np
    @HuyenBui-xu7np 2 ปีที่แล้ว

    the sound is not good I am quite disappointed

  • @khanhvu4597
    @khanhvu4597 2 ปีที่แล้ว

    so touching for an excellent video

  • @SouthAfricanCannabisExtraction
    @SouthAfricanCannabisExtraction 3 ปีที่แล้ว

    Great to find this resource on GMP! Great channel keep up the excellent work.

  • @pravin-nc9tu
    @pravin-nc9tu 3 ปีที่แล้ว

    Yesterday I read article of shoyab sir and today I got video 😁 what a surprise, thank you sir