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  • Видео 171
  • Просмотров 84 824
Mastering technical writing: Deviations, CAPAs, and SOPs
🎓 Welcome back to the Scilife Academy! In this session, you’ll gain actionable tips for technical writing in the life sciences, covering everything from concise SOPs to thorough investigations.
🧠Elevate your technical writing skills with Scilife Academy! Join other life sciences professionals today: : academy.scilife.io/app
In this video, you'll learn:
- Deviations: Write facts in chronological order, include all relevant details, and reference applicable guidelines or specifications.
- Root-Cause Analysis: Utilize tools like the 5 Whys or Ishikawa diagram to identify root causes and propose scientific hypotheses when the exact cause isn’t clear.
- CAPAs: Go beyond human error or equipment fai...
Просмотров: 54

Видео

Effective technical writing for life sciences professionals
Просмотров 40Месяц назад
🎓 Welcome back to the Scilife Academy! In this session, we’ll introduce the key concepts, processes, and best practices for technical writing to help you create precise and effective documentation in regulated environments. 🧠 The Scilife Academy is waiting for you with a diverse range of courses designed to elevate your expertise in Quality Management and Regulatory Compliance. Start today: aca...
FDA process validation stages explained
Просмотров 54Месяц назад
🎓 Welcome back to the Scilife Academy! In this session, we break down FDA Process Validation into its three lifecycle stages, based on the 2011 guidance. ✨ Learn in the flow of work with Scilife Academy and get ahead in your career! Start your learning today: academy.scilife.io/app Whether you’re refining your understanding of GMP principles or exploring lifecycle approaches, this video is for ...
Requalification and process validation in GMP
Просмотров 72Месяц назад
🎓 Welcome back to the Scilife Academy! In this lesson, we’re exploring the critical concepts of Requalification and Process Validation in Good Manufacturing Practices (GMP). 💡 Gain insights from 40 courses designed to enhance your skills in regulatory compliance and quality management. Start learning today: academy.scilife.io/app In this video, you'll learn: - Requalification: Understand how to...
How Scilife Puts People at the Center
Просмотров 45Месяц назад
In this closing session of Smart Quality Summit 2024, we explore how Scilife’s eQMS empowers life sciences organizations to move beyond compliance. We invited our customers Astrid Thorissen, Global Healthcare Quality Manager at Yusen Logistics; Sarah Vanrenterghem, Head of Quality at Precirix; Vanessa Vankerckhoven, Co-Founder and Director at Ideva to share their experience on how Scilife's eQM...
From Industry 4.0 to Industry 5.0 roundtable discussion
Просмотров 39Месяц назад
The transition from Industry 4.0 to Industry 5.0 is redefining how the life sciences sector operates. In this roundtable discussion, featuring Karen Taylor, Head of the Centre for Health Solutions at Deloitte UK; Harsh Thakkar, Founder and CEO of Qualtivate; Lesley Worthington, Communication and Leadership Coach share diverse perspectives on how Europe is embracing a more human-centric, sustain...
Cultivating a Living Quality Culture in Life Sciences: Excellence in Action
Просмотров 16Месяц назад
Quality is more than a department-it’s a mindset. In this talk, Christy Mazzarisi, MSRAQA, Principal Consultant of Quality at Network Partners Group explains how organizations can shift from viewing quality as a compliance checkpoint to making it a cultural cornerstone that drives excellence. Christy challenges organizations to define their own “quality culture,” providing a roadmap to align te...
Digital Health, AI, and Software: Lean Regulatory Market Access Now and in the Future
Просмотров 19Месяц назад
In the fast-evolving digital health sector, regulatory compliance is crucial, but it doesn’t need to slow you down. In this talk, Rudolf Wagner, CEO at ADHOCON shares effective strategies for achieving lean regulatory market access in an increasingly complex landscape. Key takeaways: - Harmonized standards: The IMDRF’s alignment of FDA and EU standards simplifies global market entry. - Lean com...
Innovating the Future: Key MedTech Trends Shaping the Medical Device Industry
Просмотров 26Месяц назад
As technology continues to advance, the need for innovative solutions that balance compliance, quality, and security has never been more crucial in the MedTech industry. In this session, Jennifer Mascioli-Tudor, Founder and CEO of JMT Compliance Consulting explores the key trends driving innovation in MedTech, from AI-driven diagnostics to the FDA’s new QMSR standards. Jennifer emphasizes the n...
Qualification Phases: IQ, OQ, and PQ Explained
Просмотров 157Месяц назад
🎓 Welcome back to the Scilife Academy! In this lesson, we explore the qualification phases: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in life sciences! 💡 Enhance your expertise with Scilife Academy! Join us to access a wide range of courses in quality assurance and compliance. Start learning today: academy.scilife.io/app In this video, w...
Industry 5.0 as a North Star
Просмотров 362 месяца назад
Industry 5.0 is redefining the future of life sciences by focusing on human well-being, sustainability, and resilience. In this talk, Lars de Nul, Deputy Head of Unit Industry 5.0 and Artificial Intelligence in Science at the European Commission explains how these key pillars are shaping a more meaningful and adaptable industry. Key takeaways: Human-centricity: Empowering people with technology...
System Qualification: URS, Functional & Design Specs
Просмотров 752 месяца назад
🎓 Welcome to Scilife Academy! In this advanced course, we cover the critical phases of System Qualification and Validation, focusing on the User Requirements Specification (URS), Functional Specifications, and Design Specifications. 🧠 Ready to deepen your knowledge? Take your knowledge to the next level with our continuous learning programs at Scilife Academy: academy.scilife.io/app In this vid...
Validation Master Plan (VMP) essentials for GMP compliance
Просмотров 1362 месяца назад
🎓 Welcome back to the Scilife Academy! In this lesson, we’re diving into the essentials of a Validation Master Plan (VMP), a cornerstone document for maintaining GMP compliance in pharmaceutical manufacturing. 🌟 Committed to continuous learning? Join Scilife Academy to keep expanding your knowledge with courses designed for quality management and validation. Take the next step in your career: a...
Control Strategy Concepts - QTPP, CQA, CPP, and CMA
Просмотров 1112 месяца назад
🎓 Welcome back to the Scilife Academy! In this lesson, we’re exploring key control strategy concepts essential for maintaining product quality in pharmaceuticals. 🎯 Enhance your expertise with Scilife Academy! Dive into high-impact courses designed to boost your skills in quality assurance. Start today: academy.scilife.io/app In this video, we cover the foundational elements of control strategi...
System validation & qualification in GMP: Key concepts explained
Просмотров 1282 месяца назад
🎓 Welcome back to the Scilife Academy! In this lesson, we dive into System Validation and Qualification in pharmaceutical manufacturing! 💡 Expand your knowledge with Scilife Academy! Explore core courses in quality assurance and more. Begin your journey today: academy.scilife.io/app In this video, we dive into the key concepts of Good Manufacturing Practices (GMP) and the critical role that sys...
Good Distribution Practices (GDP) & EU Guidelines - Chapter 9 & 10
Просмотров 803 месяца назад
Good Distribution Practices (GDP) & EU Guidelines - Chapter 9 & 10
Good Distribution Practices (GDP) & EU Guidelines - Chapter 6, 7 & 8
Просмотров 943 месяца назад
Good Distribution Practices (GDP) & EU Guidelines - Chapter 6, 7 & 8
Good Distribution Practices (GDP) & EU Guidelines - Chapter 4 & 5
Просмотров 1153 месяца назад
Good Distribution Practices (GDP) & EU Guidelines - Chapter 4 & 5
Good Distribution Practices (GDP) & EU Guidelines - Part 2
Просмотров 1083 месяца назад
Good Distribution Practices (GDP) & EU Guidelines - Part 2
Good Distribution Practices (GDP) & EU Guidelines - Part 1
Просмотров 1224 месяца назад
Good Distribution Practices (GDP) & EU Guidelines - Part 1
Understanding EU GDP Guideline 2013/C 343/01
Просмотров 1464 месяца назад
Understanding EU GDP Guideline 2013/C 343/01
Key concepts of Good Distribution Practices (GDP)
Просмотров 2084 месяца назад
Key concepts of Good Distribution Practices (GDP)
Environmental monitoring and single-use technologies
Просмотров 764 месяца назад
Environmental monitoring and single-use technologies
How to minimize contamination in aseptic processing
Просмотров 814 месяца назад
How to minimize contamination in aseptic processing
Filtration and isolator technology
Просмотров 855 месяцев назад
Filtration and isolator technology
Cleanroom classification for aseptic processing
Просмотров 1375 месяцев назад
Cleanroom classification for aseptic processing
Aseptic processing vs terminal sterilization
Просмотров 4555 месяцев назад
Aseptic processing vs terminal sterilization
Chemical sterilization methods
Просмотров 1475 месяцев назад
Chemical sterilization methods
Physical sterilization by filtration
Просмотров 656 месяцев назад
Physical sterilization by filtration
Physical sterilization in life sciences laboratories
Просмотров 456 месяцев назад
Physical sterilization in life sciences laboratories

Комментарии

  • @sajjadzaman619
    @sajjadzaman619 11 дней назад

    Super 👌

  • @sunilkadam4024
    @sunilkadam4024 13 дней назад

    Which process in GDP certificate

  • @Food-cooking.416
    @Food-cooking.416 19 дней назад

    Always love scilife lessons🎉

  • @Food-cooking.416
    @Food-cooking.416 Месяц назад

    Good explanation

    • @ScilifePlatform
      @ScilifePlatform Месяц назад

      Thank you so much for your kind words, @Food-cooking.416! We're thrilled you found the explanation helpful-your feedback keeps us motivated to create even better content. 🚀✨

  • @RajibLuchanGogoi
    @RajibLuchanGogoi Месяц назад

    it's very useful guidelines

    • @ScilifePlatform
      @ScilifePlatform Месяц назад

      Thanks so much for your kind words, @RajibLuchanGogoi! We're thrilled to hear the guidelines have been helpful for you. 😊

  • @kruthicreations
    @kruthicreations Месяц назад

    Nice

    • @ScilifePlatform
      @ScilifePlatform Месяц назад

      Thanks for your kind words, @kruthicreations! :)

  • @fasmas2293
    @fasmas2293 2 месяца назад

    Very informative highlight, great thanks

    • @ScilifePlatform
      @ScilifePlatform 2 месяца назад

      Hi, @fasmas2293! Thank you so much for your kind words! We're glad you found it informative 😊

  • @RafaIII
    @RafaIII 2 месяца назад

    Great material!

    • @ScilifePlatform
      @ScilifePlatform 2 месяца назад

      Thank you, @RafaIII! We're glad you enjoyed it!

  • @SleepyPug2050
    @SleepyPug2050 2 месяца назад

    This type of training is not helpful, you are reading from a script without any visuals and examples. I would suggest providing case studies and examples.

  • @matteosodano890
    @matteosodano890 3 месяца назад

    You are beautifull!

    • @ScilifePlatform
      @ScilifePlatform 2 месяца назад

      Thank you for your kind comment! We're glad you're enjoying the content and appreciate your support for our team :)

  • @gopinathgovindaraj8811
    @gopinathgovindaraj8811 3 месяца назад

    There is no comments. It's shock to see this. Don't worry I will comment you. This is really wonderful video and this is going to help me for my external audit. Tq so much guys..keep on posting videos like this..all the best and love from India 🇮🇳

    • @ScilifePlatform
      @ScilifePlatform 3 месяца назад

      Hey, @gopinathgovindaraj8811! Thank you so much for your kind words! Comments like yours really motivate us to keep creating more helpful content. We're so glad the video will help with your external audit. All the best, and sending love back to India! 🇮🇳

  • @andif.308
    @andif.308 3 месяца назад

    you should use (more) graphics - very boring to watch

    • @ScilifePlatform
      @ScilifePlatform 3 месяца назад

      Hey, @andif.308! Thank you for your feedback. We really appreciate your suggestion and will definitely consider adding more graphics to make the content more engaging in the future. We're always looking for ways to improve, so your input is very valuable to us!

    • @TheNyakaat
      @TheNyakaat 3 месяца назад

      @@ScilifePlatformthe absence of graphics is exactly why I enjoyed this.

    • @ScilifePlatform
      @ScilifePlatform 2 месяца назад

      @@TheNyakaat Thank you both for your feedback! We appreciate all perspectives-some viewers enjoy the simpler format, while others would love more visuals. We’ll keep both styles in mind as we continue to improve our content. Your input helps us find that balance, so thank you again for sharing your thoughts!

  • @bojohannesen4352
    @bojohannesen4352 4 месяца назад

    Etcetera. Not Excetera. ET. Not EX.

  • @bojohannesen4352
    @bojohannesen4352 4 месяца назад

    This is amazing! And the content is good too.

    • @ScilifePlatform
      @ScilifePlatform 3 месяца назад

      Thank you! We’re so glad you enjoyed it! 😊

  • @bojohannesen4352
    @bojohannesen4352 4 месяца назад

    THANK you for not adding background music. Excellent preparation for GMP courses.

    • @ScilifePlatform
      @ScilifePlatform 3 месяца назад

      Thank you so much for your feedback, @bojohannesen4352! We’re glad you found the content helpful, and we appreciate your kind words about the video preparation. Best of luck with your GMP courses!

  • @fadimeozcan2017
    @fadimeozcan2017 4 месяца назад

    Thank you for sharing. Very usefull👍

    • @ScilifePlatform
      @ScilifePlatform 3 месяца назад

      Thank you for your comment, @fadimeozcan2017! Glad to know you found it useful 👍 Your support means a lot!

  • @virendrajagtap4123
    @virendrajagtap4123 4 месяца назад

    Pupsit presentation please

  • @dharmpalsaini2022
    @dharmpalsaini2022 4 месяца назад

    Thanks for giving valuable information 🙏

  • @MrAshpakSheikh
    @MrAshpakSheikh 4 месяца назад

    Highly appreciatedn Thank You For this Knowledgeble Video

  • @ITSkillswithwahab
    @ITSkillswithwahab 4 месяца назад

    Very good presented

  • @AdamCheen
    @AdamCheen 5 месяцев назад

    Lesley presents this topic well

  • @prakashwillrocku
    @prakashwillrocku 6 месяцев назад

    ❤❤❤

  • @eslamelsamahy7528
    @eslamelsamahy7528 6 месяцев назад

    Please, what is the difference between monitoring and measuring in cluse 9.1 Thank a lot

    • @ScilifePlatform
      @ScilifePlatform 6 месяцев назад

      Thank you so much for your question, @eslamelsamahy7528! In the context of ISO 19011:2018, monitoring and reviewing are distinct but complementary activities that ensure the effectiveness and continuous improvement of an audit programme. - Monitoring involves the ongoing evaluation of the audit programme to ensure that its objectives are being achieved. It includes ongoing evaluation, continuous assessment, and feedback mechanisms. - Reviewing is a more comprehensive process that involves a systematic examination of the audit programme to identify needs for changes and opportunities for improvement. I hope this clarifies the difference for you. We're here to assist you with any further questions or clarification you may need! :)

  • @omarsheriffkaptan
    @omarsheriffkaptan 6 месяцев назад

    Brilliant presentation and full of important information. You are highly appreciated.

  • @youtubeSEOexpert520
    @youtubeSEOexpert520 7 месяцев назад

    Recently, I visited Your RUclips channel and I found some problems. I think and believe that if you can fix that problem, your channel will grow very gradually. Then your channel possible to grow. So are you interested

  • @youtubeSEOexpert520
    @youtubeSEOexpert520 7 месяцев назад

    Your RUclips video content is so good. However the video does not get many views. Because your RUclips channel has some problems. Do you want to know about the problems?

  • @Dr-vr3tu
    @Dr-vr3tu 8 месяцев назад

    Great

  • @mkkbangash
    @mkkbangash 8 месяцев назад

    Nice Information

  • @commclick
    @commclick 8 месяцев назад

    Clearly and precisely explained.

  • @omerkizilirmak4637
    @omerkizilirmak4637 9 месяцев назад

    It was great

  • @omerkizilirmak4637
    @omerkizilirmak4637 9 месяцев назад

    It was great. thanks a lot.

    • @ScilifePlatform
      @ScilifePlatform 2 месяца назад

      Thanks a lot, @omerkizilirmak4637! We're really happy you liked it. Appreciate your support! 😊

  • @sameenfatima1968
    @sameenfatima1968 9 месяцев назад

    Very Helpful! where can I find the part 2 of this video?

    • @bojohannesen4352
      @bojohannesen4352 4 месяца назад

      You can't. I eated it.

    • @ScilifePlatform
      @ScilifePlatform 3 месяца назад

      Thank you, @sameenfatima1968! We're glad you found it helpful. Part 2 is coming soon, and we’ll be sure to let you know as soon as it’s uploaded!

  • @rajeshmutyala582
    @rajeshmutyala582 9 месяцев назад

    Most effective training session, explained in a very simple and clear manner. Thank you

    • @ScilifePlatform
      @ScilifePlatform 3 месяца назад

      Thank you for your kind words, @rajeshmutyala582! Your feedback motivates us to keep improving!

  • @mishelmk
    @mishelmk 9 месяцев назад

    Thank you!

  • @mishelmk
    @mishelmk 9 месяцев назад

    Thank you! Strictly to the points. ❤ extra thanks for the examples!!!

  • @anatheodoro599
    @anatheodoro599 9 месяцев назад

    The course was very useful! All explanations were very clear and completely instructive. Thank you very much for all the support and help.

  • @aminebahlou9158
    @aminebahlou9158 9 месяцев назад

    Thanks for sharing this is very useful, Do you have a training support for ISO 19011, that you can share it with me if it is possible?

    • @ScilifePlatform
      @ScilifePlatform 9 месяцев назад

      Hi, @aminebahlou9158! Thank you for your positive feedback and inquiry about ISO 19011 training support. While we don't currently offer specific training on ISO 19011, your interest is greatly appreciated, and we'll definitely keep it in mind for future content. In the meantime, feel free to explore our playlist covering risk-based auditing according to ISO 19011:2018 - ruclips.net/p/PLXDFJne8VYYqV7u3WibBRHsXnaSB2OcUY&si=hP2BQtyiB3dRx67A We hope you find it beneficial! If you enjoy our content, don't forget to subscribe for more updates, and if you find the video helpful, please give it a thumbs up :)

  • @arsalanarifkhan4014
    @arsalanarifkhan4014 10 месяцев назад

    Thanks!

    • @ScilifePlatform
      @ScilifePlatform 3 месяца назад

      Thanks to you, @arsalanarifkhan4014! 😊 We appreciate your support!

  • @guesswho1793
    @guesswho1793 10 месяцев назад

    Very very very useful

  • @subeerhydros6457
    @subeerhydros6457 10 месяцев назад

    Very useful information

  • @ayshariaz1693
    @ayshariaz1693 10 месяцев назад

    Hi, thank you for this. Will you be adding videos for the rest of the ISO 19011 clauses?

    • @ScilifePlatform
      @ScilifePlatform 10 месяцев назад

      Thanks for your comment, @ayshariaz1693! Absolutely, we'll be covering the rest of the ISO 19011 clauses in our upcoming videos. We drop a new video on our channel every week, so keep an eye out!

  • @criscarlo
    @criscarlo 11 месяцев назад

    Well explained!

  • @RUGINATHOMAS
    @RUGINATHOMAS 11 месяцев назад

    Thanks for the chapter 2😊

  • @RUGINATHOMAS
    @RUGINATHOMAS 11 месяцев назад

    Thanks for your education 🙏 😊

    • @ScilifePlatform
      @ScilifePlatform 2 месяца назад

      Thanks, @RUGINATHOMAS! So glad you found it valuable! 🙏😊

  • @agustinnurindahpuspitasari
    @agustinnurindahpuspitasari 11 месяцев назад

    it's very helpful! Thank you so much

  • @Pandadude3000
    @Pandadude3000 Год назад

    Really helpful series for someone looking to enter the pharmaceutical industry, thanks a lot for making this publically available!

    • @ScilifePlatform
      @ScilifePlatform Год назад

      Thank you @Pandadude3000, glad you find it useful!

  • @idresgardy
    @idresgardy Год назад

    well done, but if you show us an example of each section it will be better understanding

    • @ScilifePlatform
      @ScilifePlatform Год назад

      Of course! To be able to share accurate examples, could you tell us which section would you need them from? Thank you!

    • @idresgardy
      @idresgardy Год назад

      digital signature @@ScilifePlatform

  • @bianafishman7662
    @bianafishman7662 Год назад

    Thanks ❤

  • @Kapil_Jangra1988
    @Kapil_Jangra1988 Год назад

    Very well explanation of 21CFR part 11. Is there any training program for CSV? Plz share details if any

    • @ScilifePlatform
      @ScilifePlatform Год назад

      Thank you for acknowledging the explanation of 21 CFR Part 11! Regarding CSV trainings, we highly recommend considering "Quality Systems, Computer System Validation (CSV), and Data Integrity": www.scilife.io/events-and-webinars/qa-csv-data-integritry-with-yves-dene. Thank you for bringing the broken link to our attention. We sincerely apologize for the inconvenience this may have caused. We have now updated the link, and you can access the correct one here: QA CSV Data Integrity with Yves Dene. We appreciate your understanding and support.. This AMA Webinar, with Yves Dène, offers comprehensive insights into CSV practices, aligning with regulatory standards and emphasizing data integrity within the GAMP framework. Additionally, we attach two extra resources available on our website that complement your learning: - CSV vs. CSA: What are the main differences? www.scilife.io/blog/csv-csa-main-differences - GAMP 5 and GAMP 5 2nd Edition: What are the main differences? www.scilife.io/blog/gamp-5-and-gamp-5-2nd-edition-differences

    • @Grace-jb7me
      @Grace-jb7me 7 месяцев назад

      @@ScilifePlatform Your link is broken for the training

    • @ScilifePlatform
      @ScilifePlatform 7 месяцев назад

      @@Grace-jb7me Thank you for pointing out the issue with the link. We apologize for any inconvenience this may have caused. You can now access the correct link in the comment, or you can use this direct link: www.scilife.io/events-and-webinars/qa-csv-data-integritry-with-yves-dene. We appreciate your understanding and support!

  • @AnonymousUser-in9yn
    @AnonymousUser-in9yn Год назад

    Unconstitutional thought police