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    Past editions of Smart Quality Summit

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    Smart Quality Summit 2023

    This edition is all about making quality your competitive edge. Watch the full talks with top industry experts to gain practical strategies to move beyond the 'compliance only' mindset and cultivate a strong quality culture.
     

    Smart Quality Summit 2022

    During the first edition, we focused on the re-evolution of quality. We brought together industry professionals together to re-think, re-connect, re-imagine, and re-invent the way we do quality. Watch all the recordings on demand!

     

    On demand

    Scilife events on demand to watch | Scilife
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    From CSV to CSA: Streamlining software validation with a risk-based approach

     

    Join Harsh Thakkar as he shares how to adopt a risk-based, agile approach to streamline validation and vendor management by shifting from traditional methods to the FDA’s CSA principles.
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    Simplify compliance and reduce the risk of FDA 483 findings

     

    See firsthand how to use Scilife to efficiently manage supplier questionnaires, perform risk-based assessments, and maintain a fully audit-ready documentation trail — all in one centralized platform.
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    How to survive and thrive in FDA and EU inspections for GxP - Ask the expert


    Watch Andrés Gola, Senior Consultant at PBSV, tackle top regulatory audit questions — from pre-inspection prep to post-audit compliance and future trends.
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    ICH Q9 Quality Risk Management in action with Scilife


    Tired of complex risk management? In this webinar, our experts walk you through a real use case — a risk assessment of document control in a paper-based system.
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    How to win buy-in for quality investments with a soft skills approach


    Learn how to gain buy-in for quality initiatives using soft skills, influence principles, and stakeholder alignment, with insights from Lesley Worthington and Àngel Buendía.
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    Top strategies to tackle data governance and lifecycle obstacles in life sciences


    Discover how to structure data, avoid common pitfalls, and improve decision-making with real-life examples, led by Kurt In Albon and Àngel Buendía.
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    Turning your QMRs into drivers of lasting improvement


    Learn how to spot improvement opportunities, boost cross-functional collaboration, and drive impactful results with insights from Àngel Buendía and Didier Giffroy.
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    Beyond compliance: How Scilife's eQMS drives GMP success


    Discover how a unified eQMS can ensure GMP compliance while fueling continuous improvement and strategic growth in life sciences.
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    Harmonizing Quality Across Sites: Unifying Your QMS for Consistency and Efficiency


    Explore how a harmonized QMS streamlines operations by aligning quality processes, minimizing risks, and eliminating redundant costs.
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    Maintain data integrity in your paper processes


    Discover how Scilife’s Print & Reconciliation solution maintains data integrity, automates document tracking, and ensures compliance in paper-based GMP workflows.
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    Speaking the language of leadership: Aligning compliance with business priorities


    Learn key communication techniques from Kathy Walsh to position compliance as a business priority and align it with organizational goals to gain leadership support.
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    Quality First: How to reduce deviations and cultivate a quality-driven environment with Scilife


    Discover how Scilife’s Events Solution helps manage deviations, strengthen quality culture, and drive continuous improvement in your QMS.
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    Enhancing Change Management and Supplier Qualification with Scilife


    Discover how Scilife’s Change Control solution streamlines change management in regulated industries, with a real case on resolving a daily calibration issue.
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    Best Practices Applying AI GPT in your QMS


    Join Matin King as he guides you through implementing AI GPT models in QMS to enhance quality, minimize risks, and drive innovation while ensuring regulatory compliance.
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    How to Build a Quality Culture


    Join Àngel Buendía and Lesley Worthington as they guide you through embedding quality into every aspect of your organization and building a robust quality culture.
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    Transform your IVD Quality System with Scilife


    Discover how Scilife’s Smart QMS streamlines compliance, enhances document control, and fosters a proactive quality culture under the new IVDR regulations.
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    Become a pro at CAPA implementation with Scilife


    Discover how Scilife’s Smart QMS transforms CAPA management by streamlining workflows, fostering collaboration, and enabling agile corrective and preventive actions.
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    Key considerations for SaaS eQMS validation


    Join Àngel Buendía and Angela Bazigos as they discuss SaaS eQMS validation, covering GaMP5 compliance, deliverables, and the roles of your company and the vendor.
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    Achieve excellence with effective auditing


    Gain expert insights into effective pharmaceutical supply chain auditing, covering stakeholder roles, auditor qualifications, and case studies on GMP, GDP, and more.
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    Activando la Transformación Digital en la Gestión de Calidad con Scilife


    Descubre cómo la transformación digital puede mejorar la eficiencia, reducir costes y asegurar el cumplimiento normativo en la gestión de calidad.
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    Take your employee training program to the next level with Scilife


    Discover how a Smart QMS helps monitor training progress, ensure compliance and traceability, and automate onboarding, training, and role transitions.
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    Secrets to Getting Your Team to Write User-Friendly Documents


    Join Dr. Kathy Walsh for a practical guide on turning QMS documents from a liability into a plain language asset using a clear writing framework that boosts document quality.
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    Facing 21 CFR Part 211 Warning Letter citations with Scilife


    Discover how a Smart QMS streamlines discrepancy recording, simplifies procedure management, and empowers your workforce with essential equipment maintenance skills.
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    Unlocking the Power of Critical Thinking in CSV


    Join Joseph Turton as he explores how critical thinking enhances regulatory navigation, ensures data integrity, and addresses CSV challenges, offering practical techniques for integration into validation processes.
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    Navigating FDA's QMSR Final Rule with Scilife


    Discover how Scilife’s smart QMS helps medical device companies navigate the new FDA QMSR and align with ISO 13485, ensuring compliance and improving efficiency with a real industry example.
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    Master Internal Audits with Scilife


    Discover how Scilife’s smart QMS simplifies audit management, turning internal audits into an opportunity for continuous improvement while reducing time and effort.
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    Scilife Document Control: The Ultimate Document Management Solution for Life Sciences companies


    Discover how Scilife’s Document Control solution simplifies document management, customizes approval workflows, and maintains a clear audit trail with a real-world example.
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    How to write design and development inputs to meet ISO 13485 requirements


    Join Peter Sebelius for a practical guide on developing requirements in the medical device sector, focusing on the role of clear requirements and strong design inputs in ensuring regulatory compliance and effective product development.
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    Quality Management Review Made Easy with Scilife

    The Quality Management Review is a formal process for assessing the performance of a company's quality management system (QMS). This process is essential for any QA department.
    In this Showcase, we will go through the main contents of a Quality Management Review Report, and demonstrate how Scilife can help you streamline its preparation.
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    Quality and Compliance


    Watch Rodrigo Nasif discuss the critical synergy between quality and regulatory compliance, sharing practical strategies and real cases to optimize processes and make informed decisions.
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    The 5 Keys to Earn ISO 13485 Certification with Scilife


    Discover how Scilife eQMS improves document management, protects data integrity, enhances audit management, and supports ISO 13485 certification readiness with a real-world example.
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    Boost your GMP change management process with Scilife


    Discover how Scilife’s Change Control Management solution helps evaluate, approve, and implement changes to meet regulatory updates, drive continuous improvement, and adapt to new technologies with a real-world example.
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    Ensure Data Integrity of Printed Documents with Scilife


    Discover how Scilife’s Print & Reconciliation solution ensures data integrity and compliance with 21 CFR Part 11 by using barcode systems and setting up an approved printer network for print control.
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    Best Practices and Soft Skills for Auditing Training

    In this free training with Carla Peraferrer, Vice President of Quality at Qualifyze, and Jordi Ferrando, Quality Manager & Auditor at Qualifyze, we’ll delve into auditing best practices and key soft skillsthrough four case studies to gain comprehensive knowledge to nail your upcoming audits.
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    Simplify the process of implementing GDP requirements withScilife Smart QMS

    In this free session, you’ll see a real-world example of how Scilife Smart QMS works. You'll learn how to implement the GDP principles, rules, and criteria in your quality management system. 
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    Simplify the Maintenance process with Scilife Equipment Management Software

    In this free session, you’ll see a real-world example of how Scilife’s Equipment ManagementSoftware works. You'll learn how to use it to simplify the maintenance process, by creating and managing recurring maintenance and calibration programs.
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    Avoid compliance failure with Scilife’s Print & Reconciliation Solution

    In this free session, you’ll see a practical demonstration of how Scilife’s Print & Reconciliation solution works, you’ll learn how to use the barcode system, and how to set up an approved printer network to have control over your prints and follow data integrity requirements. 
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    Avoiding Common cGMP Pitfalls with Scilife

    In this free session, you’ll discover the main errors in cGMP environments and a use case of how to avoid inadequate deviation investigations & poor root cause analysis with Scilife. 
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    Removing Audit Stress with Scilife Audits Management Software

    In this free session, you’ll see a practical demonstration of how Scilife’s Audits Management software works, you’ll learn how to go through any audit process, and how to mitigate finding by linking Audits’ solution with CAPAs, quality events, or change management.
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    Empower GLP Compliance with Scilife

    Discover how Scilife can help you implement the GLP rules and criteria in your quality management system.

    Don't let the complexities of GLP impede your progress, and learn how to navigate this terrain!
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    Unlock Digital Transformation for Quality Management with Scilife

    Discover how Scilife’s Smart Quality Platform can revolutionize your organization's digital capabilities and improve productivity!
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    Learn how to optimize your trials with Scilife to make your next sponsor’s audit a breeze!

    Discover how Scilife can improve your clinical trial processes and help you succeed in your sponsor's audit!
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    Smart Quality: The New Paradigm

    Discover how Smart Qualityempowers Life Sciences organizations to increase productivity and speed in Quality Assurance processes by up to 40% and reduce the total Cost of Quality by up to 50%!
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    Documents & Records

    In this free workshop, you’ll see a practical demonstration of how Scilife’s Document Control & Records Management software works, you’ll learn how to overcome the challenge of optimizing your document management to keep it centralized and clean, and how to easily create customizable and digital forms to avoid unnecessary data.
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    Smart Quality: the backbone of continuous improvement

    Only available for registrants

    In this webinar, Evgeniya Makarova enlightened us with the introduction of the Smart Quality approach, a new way of understanding Quality that involves automated and digitized processes and procedures, design-thinking, artificial intelligence, and advanced analytics, to empower a Quality and Continuous Improvement culture. 
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    How to leverage Natural Language Processing (NLP) in the Life Sciences industry

    In this talk, Sami Nas provides an overview of the Natural Language Processing discipline, answer why it is needed in the Life Sciences, and showcase specific use cases of how it can improve efficiency and effectiveness.
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    Master-Class Artificial Intelligence Validation Consideration - AI/ML

    In this webinar, Jonathan Boel dives into the key aspects around Artificial Intelligence and Machine Regulations, such as the different initiatives proposed by international authorities, the objectives, requirements, and impact of the regulations, and the validation considerations for both Artificial Intelligence and Machine Learning.
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    Software as a Medical Device

    Software as a Medical Device, Medical Device Software, Software in a Medical Device… All these concepts can end up being confusing. In this Ask Me Anything Session, Mika Siitonen clears up all the related questions from our audience.
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    Everything you want to know about CAR-T

    In this Ask Me Anything Session, Lieve De Wolf solves all the questions of the audience around the types of Advanced Therapy Medicinal Products, the classification and the manufacturing process, and the regulatory framework.
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    Six ways the metaverse will help shape the future of pharma

    In this webinar, Robin Kerbel, CEO & Co-Founder at Six Degrees Medical, and Carolyn Whiting, EVP, Strategy & Innovation at Six Degrees Medical, have an interactive discussion dissecting case studies and summarizing how Pharma, Biotech and Medical device companies can make an impact in the metaverse, through quality training and interactions with stakeholders.
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    Learn about fundraising as a Pharma or MedTech company

    In this webinar, Franziska Stemmler, Chief Operating Officer at Hemex, shares with us what we need to take into account when we’re facing a fundraising process (the most important actions to take before, during, and after fundraising) and general dos and don’ts.
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    Print & Reconciliation Solution Workshop

    In this free workshop, you’ll see a practical demonstration of how Scilife’s Print & Reconciliation solution works, you’ll learn how to overcome the challenge of printing and reconciling in a regulated environment, keeping Data Integrity, and being fully compliant with FDA 21 CFR Part 11.
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    Ace audits & inspections with Scilife

    1_Learn how to gather all the required information in no time
    2_Manage supplier qualifications, supplier audits, internal audits, and incoming audits in just one place
    3_Turn audits into a tool to foster continuous improvement, instead of a hassle
    Equipments

    Scilife’s Equipment Management Solution

    In this free workshop, you’ll see a practical demonstration of how Scilife’s Equipment solution works, and you’ll learn how to keep all your qualifications, recurrent maintenance, and calibration tasks in order and up to date.
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    How to build a Quality ecosystem in a Medical Device 3D Printing company?

    Amnovis, a contract manufacturing company, will talk about achieving compliance and flexibility from day one, and going to market faster while cultivating an Innovation and Quality Ecosystem.
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    AMA: Performing Risk Management under MDR/IVDR

    Mika Siitonen, Medical Development Manager at Labquality, answers your questions about Risk Management under MDR/ IVDR, which has an impact on your quality system, medical device product, clinical evaluations, and much more.
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    How to stop burnout, so work-life balance is a reality not a utopia?

    But what is burnout? What are the triggers? Is it preventable and if so, how? Andrew Pain, TEDx / Keynote speaker, shares everything we need to know about burnout!
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    Competences Matrix: How to get the most out of your team

    In this free workshop, Filip presents an efficient way of tracking the knowledge and skills of the teams with Scilife’s Competences functionality, which will allow you to invest your people in the tasks they do best.
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    AI: The path to empower us to superhuman performance

    Discover how the company Relu is adopting and implementing AI technologies, discover all about  market acceptance of AI applied to Life Sciences, and dive into the advantages and disadvantages of this new technology.
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    Being the pioneer: Helius, the first medicinal cannabis company in NZ to be GMP certified

    1_Challenges of being the first

    2_Regulatory requirements of new market opportunities

    3_Merging cannabis agriculture with pharma industry

    4_Live Q&A session
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    Scilife Record Management Solution: Get rid of your paper records and paper forms

    Companies needs to create, fill out and store lots of forms and they are usually dense and dull. In this workshop, Filip presents a revolutionary way of creating and managing your records with our new Record Management solution.
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    Go-to-market strategy of a certified ISO13485 medical device

    With Vanessa Vankerckhoven,
    CEO and co-founder of Novosanis

    1_Go-to-market strategy

    2_How to get ISO 13485 certified

    3_Quality management in pre-market and post-market phases

    4_Pre-acquisition vs post-acquisition
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    KPI Solution: How Scilife tackles KPIs to fuel growth

    Real-time performance insights and historic trends at your fingertips! In this free webinar, Filip enlightens us on how to keep track of your quality processes while discovering areas for improvement within Scilife.
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    Customer Centric Approach: Quality as the backbone of BD in Healthcare

    In this free Scilife webinar, Filip Heitbrink speaks with Marloes Seesing about Yusen Logistic's approach to successful business development by merging quality with sales.
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    Benefits of a Well-Executed Change Control Management

    Filip goes through the fundamentals of our Scilife Change Control module, making sure your project and organization can reap the benefits and avoid the pitfalls of a bad change control process.
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    Scilife CAPAs Solution Workshop

    In this free Scilife webinar, Filip Heitbrink explains the nuts and bolts of our Scilife CAPAs module and how to use it to effectively manage your CAPAs, followed by a Q&A session.
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    Continuous Improvement in a fast-growing Medical Device company

    With Amanda Amell 

    Enjoy the expertise of Amanda Amell, QA expert at Shoebox, who will explain the Continuous Improvement Framework, the main challenges and the Shoebox case study.
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    Scilife Events Solution Workshop

    In this one-hour session, our CEO Filip Heitbrink explains the nuts and bolts of our Scilife Events module, and how to use it like a pro to effectively manage your deviations & nonconformities. Followed, as usually, by a live Q&A session.
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    Data security of a cloud-based application in Life Sciences

    With Amazon (AWS)

    We’re thrilled that Patrick Lamplé, the expert on data security in the life sciences sector at Amazon Web Services (AWS), joined Filip Heitbrink in this webinar to share his valuable insights on the subject.
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    Document Control +Trainings Solutions Workshop

    New Scilife features

    Our CEO Filip Heitbrink explains how these two handy modules can help you set up a fully compliant Document Control system and training matrix for your team.
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    Risk Assessment Solution Workshop

    Scilife has a new module! Finally, risk management is made a whole lot simpler, as well as accessible by everyone; manage the full risk assessment process, link risk assessments to deviations, non-conformities, CAPAs, oraudits, customise the module and set up periodic review notifications.
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    Quality Systems, Computer System Validation (CSV), and Data Integrity

    With Yves Dène

    An interactive Q&A webinar with Yves Dène, Knowledge Manager at QbD, that answers all your questions about how to reach an embedded quality system and ensure data integrity.
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    One Woman’s Journey into Science and Tech

    with Lučka Bibič

    In this Q&A session with Lučka Bibič, you’ll discover how gamification can be used to improve quality within the Life Sciences, how scientific research was turned into a VR game, and how women can overcome the challenges they face in science and tech. 
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    Master your IVD Complaint Management with Scilife

    Implementing a solid Complaint Management System directly impacts the safety of your IVD during post-market surveillance!
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    Smart Quality mindset in your organization.

    Filip Heitbrink showcases a practical example of how the transformative Smart Quality approach can be implemented in a Quality Management platform such as Scilife, to help Life Sciences companies engage the whole organization with Quality and turn it into a catalyst for value creation instead of a cost of doing business.
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