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    Upcoming

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    Scilife Showcase

    Master Internal Audits with Scilife

    Apr 25, 2024 11:00 AM (CEST)

     

    Are you struggling with planning and carrying out internal audits?
    Join us for an insightful online event focused on leveraging Scilife's Audits solution for seamless audit management.
     
    In this engaging session, we will delve into the complexities of performing internal audits, through the specific use case of a warehouse department.
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    Scilife Training

    Unlocking the Power of Critical Thinking in CSV

    Apr 30, 2024 11:00 AM (CEST)

     

    Join our online session, offering an in-depth exploration into applying critical thinking throughout the Computerised System Validation (CSV) lifecycle.
     
    Discover the pivotal role that analytical and evaluative thinking plays in navigating regulatory landscapes, ensuring data integrity, and fostering successful system validations within regulated industries.
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    Scilife Training

    Secrets to Getting Your Team to Write User-Friendly Documents

    May 16, 2024 11:00 AM (CEST)

     

    In our next Training 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 explore the secrets to implementing a plain language writing framework that will immediately improve the quality of your procedural documents.
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    Scilife Showcase

    Facing 21 CFR Part 211 Warning Letter citations with Scilife

    May 23, 2024 11 AM (CEST)

     

    In our upcoming Showcase, we'll explore the three most frequently cited sections of the current Good Manufacturing Practice for Finished Pharmaceuticals (21 CFR Part 211) regulations from 2023-2024. We'll illustrate how Scilife’s cutting-edge Smart QMS can serve as your ultimate compliance solution.

    Latest content

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    Scilife Showcase

    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.

    On demand

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    Scilife Showcase

    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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    Scilife Training

    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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    Scilife Showcase

    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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    Scilife Training

    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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    Scilife Showcase

    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 system while 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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    Scilife Showcase

    Boost your GMP change management process with Scilife

    In this free session, you’ll see a real example of how Scilife Change Control Management solution works. 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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    Scilife Training

    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 skills through four case studies to gain comprehensive knowledge to nail your upcoming audits.
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    Scilife Showcase

    Overcome the complexities of the GLP requirements with Scilife 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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    Scilife Showcase

    Simplify the Maintenance process with Scilife Equipment Management Software

     

    In this free session, you’ll see a practical demonstration of how Scilife’s centralized quality processes and its risk-based approach will help you manage quality throughout all stages of the clinical trial process. 
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    Scilife Showcase

    Unlocking Digital Transformation for Quality Management

     

    In this free Scilife Showcase, we look at the challenges and benefits of going fully digital. Our real-life case study showcases Scilife's approach to digital transformation. Learn how our innovative digital solutions can boost productivity by up to 40%. With 80% of Life Science companies lagging behind in digitalization, this is your chance to get ahead of the game!
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    Scilife Showcase

    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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    Scilife Showcase

    Simplify the process of implementing GDP requirements with Scilife Smart QMS

     

    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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    Scilife Showcase

    Handling key GDP requirements with Scilife

     

    In this free session, you’ll see a practical demonstration of how Scilife’s centralized quality processes and its risk-based approach will help you manage quality throughout all stages of the clinical trial process. 
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    Scilife Showcase

    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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    Scilife Showcase

    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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    Scilife Showcase

    Handling key GDP requirements with Scilife

     

    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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    Scilife Showcase

    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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    Scilife Showcase

    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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    Scilife Showcase

    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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    Scilife Showcase

    Avoiding Common cGMP Pitfalls with Scilife


    Manufacturing consistent high-quality products while complying with cGMP isn’t always easy. Fortunately, you’re not the first one to take this journey. In this Showcase, you'll learn how you can avoid the most common pitfalls with Scilife!
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    Webinar

    Smart Quality: The New Paradigm

     

    Discover how Smart Quality empowers 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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    Workshop

    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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    Summit

    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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    Summit 

    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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    Summit

    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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    Summit | Master-Class

    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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    Summit | AMA Session

    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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    Summit | AMA Session

    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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    Summit

    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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    Webinar

    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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    Workshop

    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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    Workshop

    Ace audits & inspections with Scilife

     

    Ease all your audits and inspection processes! 

    • Learn how to gather all the required information in no time 
    • Manage supplier qualifications, supplier audits, internal audits, and incoming audits in just one place
    • Turn audits into a tool to foster continuous improvement, instead of a hassle
    Equipments

    Workshop

    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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    Live Webinar

    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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    Workshop

    Scilife Competences Functionality Workshop

     

    In this free workshop, you’ll see a demo of the Scilife Competences Functionality, and you’ll learn the importance of tracking competences and skills within the company, how to define a competences matrix in 2 easy steps, how competences can be integrated with Scilife Trainings and how to define your CV form, ensuring uniformity, updated by employees themselves. 

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    Ask Me Anything Webinar

    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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    Live Webinar

    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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    Workshop

    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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    Live Webinar

    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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    Scilife Showcase

    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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    Live Webinar

    Being the pioneer: Helius, the first medicinal cannabis company in NZ to be GMP certified

     

    > Challenges of being the first
    > Regulatory requirements of new market opportunities
    > Merging cannabis agriculture with pharma industry
    > Live Q&A session
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    Workshop

    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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    Live Webinar

    Go-to-market strategy of a certified ISO13485 medical device

    With Vanessa Vankerckhoven,
    CEO and co-founder of Novosanis

     

    > Go-to-market strategy 
    > How to get ISO 13485 certified
    > Quality management in pre-market and post-market phases
    > Pre-acquisition vs post-acquisition
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    Workshop

    KPI Module: 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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    Live Webinar

    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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    Workshop

    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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    Workshop

    Scilife CAPAs Module 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.

    CI

    Live Webinar

    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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    Workshop

    Scilife Events Module 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. 

    Illustration of a cloud in pink background to illustrate data security concept in cloud-based applications | Scilife

    Webinar

    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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    Workshop

    Document Control +
    Trainings Modules 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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    Workshop

    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, or audits, customise the module and set up periodic review notifications.
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    AMA (Ask Me Anything) Webinar

    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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    Scilife Showcase

    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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    Scilife Showcase

    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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