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    Events and webinars at Scilife | Scilife

    Upcoming

    Sandglass symbolizing upcoming events for Scilife | Scilife
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    Training

    From CSV to CSA: Streamlining software validation with a risk-based approach

    Apr 10, 2025 4 PM (CET)

    In this session, we’ll show you how to revamp your approach by integrating the FDA’s emerging Computer Software Assurance (CSA) principles into your system validation and vendor management programs.

     
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    Showcase

    GMP change management: Jumping on the fast track from deviation to resolution

    Apr 24, 2025 11:00 AM (CEST)

    In this free showcase, we'll walk you through a real-world use case involving a deviation in a pharmaceutical product's repackaging process, highlighting how Scilife enables you to maintain compliance, ensure traceability, and optimize your change management workflows. 

     
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    eQMS Series

    Spotting Quality System must-haves: Choosing the one that works for you

    Apr 29, 2025 04:00 PM (CEST)

    This online event is designed to guide you through the essential considerations when choosing an electronic Quality Management System (eQMS). We''ll provide insights into industry requirements and best practices, and demonstrate these points with practical key learnings from his experience.

     

    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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    How to survive and thrive in FDA and EU inspections for GxP - Ask the expert

    Watch an exclusive AMA session with Andrés Gola, Senior Consultant at PBSV, who brings 15 years of experience in FDA-regulated environments. He answered the most pressing live and pre-submitted questions from the life sciences community, covering everything from pre-inspection preparations to post-audit compliance and the future of regulatory audits.

     
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    How to win buy-in for quality investments with a soft skills approach

    In this free session, Lesley Worthington, Communication & Leadership Coach, and Angel Buendía, Scilife’s Knowledge Manager, will help you turn resistance into agreement on quality investments using soft skills. They will show you how to build strong relationships, understand stakeholder goals, use principles of influence, and communicate effectively to ensure you finally get your green light for quality.

     
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    Top strategies to tackle data governance and lifecycle obstacles in life sciences

    In this free session, Kurt In Albon, Global Head of Information Quality at Lonza, and Scilife’s Knowledge Manager, Àngel Buendia, will show you how to define data structures effectively, avoid the common data pitfalls, and make data work for you in the long term. They’ll also go through real world examples where data quality is a make-or-break factor for you to learn from and improve your decision-making.

     
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    Turning your QMRs into drivers of lasting improvement

    In this free session, Angel Buendia, Scilife’s Knowledge Manager, and Didier Giffroy, Head of Quality & Regulatory Affairs at DiaSource ImmunoAssays, will show you how to identify opportunities for improvement, strengthen cross-functional connections, and deliver actionable outcomes that will benefit your entire organization. 

     
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    Beyond compliance: How Scilife's eQMS drives GMP success

    At Scilife, we help life sciences companies ensure GMP compliance while driving continuous improvement and operational excellence. Join us for this free session to discover how a global, unfied eQMS can be your catalyst for growth and strategy.

     
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    Harmonizing Quality Across Sites: Unifying Your QMS for Consistency and Efficiency

    Join us for this free session to discover how a global, harmonized QMS can transform operations by aligning quality processes, reducing risks, and cutting down on redundant costs and resources.

     
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    Maintain data integrity in your paper processes

    Join us for this free showcase to discover how Scilife's Print & Reconciliation solution helps you maintain data integrity, automate document tracking, and ensure regulatory compliance while working with paper-based processes in GMP environments.

     
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    Speaking the language of leadership: Aligning compliance with business priorities

    In this free training, Kathy Walsh, a renowned GxP and Plain Language Specialist, will share essential communication techniques to elevate compliance as a core business priority. Discover actionable strategies to align your compliance initiatives with organizational goals and communicate their value to senior leadership.

     
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    Quality First: How to reduce deviations and cultivate a quality-driven environment with Scilife

    Join us for this free session to discover how Scilife’s Events Solution can transform your organization’s approach to managing deviations, fostering a robust quality culture, and driving continuous improvement in your quality management practices.

     
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    Enhancing Change Management and Supplier Qualification with Scilife

    Join us for this free session to discover how Scilife's Change Control solution can transform your change management processes in regulated industries. A daily calibration problem will be illustrated showing how to identify the problem, implement corrective actions, and manage changes.

     
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    Best Practices Applying AI GPT in your QMS

    In this free session, Matin King, Regulatory Affairs & Quality Assurance expert, will guide you through the strategic implementation of AI GPT models in Quality Management Systems. You'll discover how to harness the power of AI to enhance quality processes, minimize risks, and drive innovation while maintaining regulatory compliance. 

     
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    How to Build a Quality Culture

    In this free session, Angel Buendia, Scilife’s Knowledge Manager, and Lesley Worthington, Communication and Leadership Coach will guide you through the essentials of embedding quality into every facet of your organization. They will explain why a robust quality culture is essential and outline the steps needed to achieve it.

     
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    Transform your IVD Quality System with Scilife

    Join us in this free session to discover how Scilife's Smart QMS can help you streamline compliance processes, enhance document control, and foster a proactive quality culture that supports continuous improvement under the new IVDR regulations.

     
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    Become a pro at CAPA implementation with Scilife

    Many companies struggle with complex workflows and siloed information, making it difficult to manage corrective and preventive actions efficiently. Join us in this free session to discover how Scilife's smart QMS transforms your CAPA management by streamlining and optimizing workflows, fostering effective collaboration, and enabling agile CAPA management.

     
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    Key considerations for SaaS eQMS validation

    In this free session, Angel Buendia, Scilife’s Knowledge Manager, andAngela Bazigos, CEO at LEADER Compliance Consulting, will discuss the critical aspects of validating SaaS eQMS systems. They will cover SaaS validation to comply with GaMP5 requirements, the expected deliverables, and the roles and responsibilities of your company versus the vendor.
     
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    Achieve excellence with effective auditing

    In this free session, we will offer expert insights into effective auditing in the pharmaceutical supply chain. Discover the roles and responsibilities of key stakeholders, understand essential auditor qualifications, and delve into case studies on GMP, GDP, and other critical areas.
     
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    Activando la Transformación Digital en la Gestión de Calidad con Scilife

    Es crucial avanzar hacia este cambio para mejorar la eficiencia, reducir costes y asegurar el cumplimiento normativo. Únete a nosotros en esta sesión gratuita donde exploraremos cómo la transformación digital puede revolucionar la gestión de calidaden la industria.
     
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    Take your employee training program to the next level with Scilife

    Discover how a Smart QMS can help you: 

    1_Monitor employee training progress and performance

    2_Ensure compliance and traceability

    3_Automate training management and streamline onboarding and role transitions

     
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    Secrets to Getting Your Team to Write User-Friendly Documents

    In this free session, Dr Kathy Walsh, Principal Consultant and Founder of Quality Systems Now, will offer a practical guide to transforming your QMS documents from a company liability to a plain language company asset. She will teach you to implement a plain language writing framework that will immediately improve the quality of your procedural documents.
     
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    Facing 21 CFR Part 211 Warning Letter citations with Scilife

    Discover how a Smart QMS can help you: 

    1_Streamline discrepancy recording and root cause analysis

    2_Simplify drafting, review, approval, and application of procedures

    3_Empower your workforce with essential equipment maintenance skills

     
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    Unlocking the Power of Critical Thinking in CSV

    In this free session, Joseph Turton, QA Manager and CSV Specialist at The Knowlogy delivers an insightful examination of the application of critical thinking throughout the CSV lifecycle. He delves into how critical thinking enhances regulatory navigation, ensures data integrity, addresses challenges in CSV, and offers practical techniques for its integration into validation processes. 
     
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    Navigating FDA's QMSR Final Rule with Scilife

    The new FDA Quality Management System Regulation (QMSR) and its alignment with the ISO 13485 standard opens up a new era for medical device companies which will require them to make important updates to maintain compliance and work more efficiently.

    In this free session, you’ll see a real industry example of how Scilife smart QMS can enable your organization to navigate QMSR topics with ease.

     
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    Master Internal Audits with Scilife

    Internal audits are a perfect opportunity to build a continuous improvement culture within the organization, but they are usually quite time-consuming for teams and end up representing a burden.

    In this free session, you’ll see a real example of how Scilife smart QMS simplifies the overall process to improve and ease your audit management. 

     
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    Scilife Document Control: The Ultimate Document Management Solution for Life Sciences companies

    In this free session, you’ll see a real example of how Scilife’s Document Control solution works. You’ll learn how to easily manage all the documents within your organization, customize and streamline approval cascades, and keep a clear audit trail.

     
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    How to write design and development inputs to meet ISO 13485 requirements

    In this free session, Peter Sebelius (CEO and Founder of Medical Device HQ) offers a practical guide to developing requirements in the medical device sector. He explores the crucial role of clearly defined requirements and strong design inputs in guaranteeing adherence to regulations and the accomplishment of 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

    In this training, Rodrigo Nasif, Director of Pharmware, will uncover how the synergy between quality and regulatory compliance is critical to the success and sustainability of any organization. Watch the recording and discover practical strategies backed by real cases to learn how to optimize your processes and make more informed decisions!
     
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    The 5 Keys to Earn ISO 13485 Certification with Scilife

    In this free session, you’ll see a real example of how Scilife eQMS works. You’ll learn how to improve your document management systemwhile protecting data integrity, manage your internal and vendors’ audits more effectively, and perform risk assessments, to get your company ready for ISO 13485 certification. 
     
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    Boost your GMP change management process with Scilife

    In this free session, you’ll see a real example of how Scilife Change Control Management solutionworks. You’ll learn how to evaluate, approve, and implement changes to cope with regulatory updates, implement continuous improvement initiatives, and adapt to novel technologies. 
     
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    Ensure Data Integrity of Printed Documents with Scilife

    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, how to set up an approved printer networkto have control over your prints and follow data integrity and 21 CFR Part 11 requirements.
     
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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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