Getting ready for EU MDR ready for EU MDR​October 2 | Webinar The EU Medical Device Regulation (MDR – 2017/745) entered into force in May 2017 and will reach its full implementation in May 2020. MDR requires all companies that market devices in the EU must ensure not only compliance, but also an efficient implementation of internal adequate processes, technology and documentation according to the regulation. The first important step to compliance is to identify your process and technology gaps, conduct a risk assessment and clarify new necessary documentation. With NNIT’s deep roots in the Life Sciences domain and vast experience with assisting our clients in their journey to compliance, we have the foundation to help you in your adoption of MDR. NNIT has also developed an EU MDR Assessment Tool, which helps you discover all new relevant MDR initiatives (2017/745) for your organization and thereby avoid redundant work and costs as well as delayed compliance. Join this webinar to learn more about MDR and the steps to compliance. Agenda - EU MDR - Obstacles and New Requirements- Approach to Compliance - NNIT's Framework- EU MDR Readiness Assessment Tool - Demo- How to Form and Execute your EU MDR Project- QuestionsSpeakers Martin Rother Breyen, Senior Business Consultant, NNIT and Bjarne Wiboe, Subject Matter Expert, NNIT Time and Date 3 PM CEST / 3 AM ET, Tuesday October 2, 2018 Click here to sign up
Webinar: Get IFRS16 compliant with SAP Flexible Real Estate (RE-FX) & Asset Accounting (FI-AA) Get IFRS16 compliant with SAP Flexible Real Estate (RE-FX) & Asset Accounting (FI-AA)October 3 | Webinar ​The new global lease accounting standard will impact company’s lease-in portfolio and create potential cost savings strategies opportunities. IFRS 16 specifies how an IFRS reporter will recognize, measure, present and disclose leases. The standard provides a single lessee accounting model. The first official transition date is 1st of January 2019, starting with public business entities and the second is 1st of January 2020 with an interim period of additional one year (2021) applying to non-public entities. SAP standard can make you IFRS 16 compliant. REGISTER HERE Agenda - What are the main parts of the IFRS 16 standard? - What is the important business considerations? - System considerations? - Time perspective - Project models - NNIT case story Speaker Hans Mathiesen, Senior SAP Consultant, NNIT
Delivering Customer Experiences with AI Customer Experiences with AIOctober 4 | SøborgWe are all exposed to customer experience in our everyday life but what is it all about? Customer experience (cx) is about giving your customers the best experience with your brand across all relevant touchpoints. It is important to understand customer behavior in order to create unique CX that engages. By implementing Artificial Intelligence you can improve the way you deliver value as it will grow efficiency in your processes and gain competitive advantage that ultimately will make sure that your customers are getting their expectations exceeded. Join this seminar and hear how NNIT has worked with Customer Experience and what learnings and impact it has made in the organization. Hjaltelin Stahl will share their experience of advising and getting started with CX in companies and what to be aware of. Finally, we will present cases with AI on how to optimize the way you deliver customer experience by utilizing on new technologies. Agenda 0830 - 0900 Breakfast and registration0900 - 0910 Welcome by Thomas Schjødt, NNIT 0910 - 1000 CX - how to get started - Hjaltelin Stahl 1000 - 1015 Break1015 - 1045 What is AI - Supwiz 1045 - 1130 How do you use AI to improve your CX - Supwiz 1130 - 1145 Final notes - Thomas Schjødt, NNIT 1145 - Lunch and networking
Regulatory Affairs Transformation brings you into the future Affairs Transformation brings you into the futureOctober 10, 3:00-3:30 PM (CET) | WebinarOver the past decade, Regulatory Affairs has been undergoing a significant change. Technology has evolved, but with increasing requirements from authorities, it has been challenging to keep up with technological innovation and has led to complex and costly IT management. Most RA architectures have fallen behind on technology, hence not reaping the benefits of innovation and IT optimization. Join our webinar and learn how Regulatory Affairs Transformation can bring you into the future. During the webinar Rune Bergendorff, Director, Life Sciences Delivery, NNIT will go through The changing role of Regulatory Affairs and drivers for change Industry movements – benchmark yourself against others What are the main challenges/obstacles and how are you addressing these? The move from siloed applications to a unified platform – for better data insights and processes Click here to sign up
High Tech Summit Tech SummitOctober 10-11 | DTU Join High Tech Summit and hear various NNIT presentations during the two days. NNIT will be present at the summit and facilitate workshops and participate in key notes panels during the two days. Below you have the chance to get a sneak peak on what topics we will present Wednesday October 10, 10.30-12.00, Entrepreneurship track, Pretotyping workshop, "Pretotyping", Yasemin Sanchez, Consultant, NNIT Wednesday October 10, 12.45-14.00, Entrepreneurship track, Workshop, "Workshop on how to get started with corporate entrepreneurship - and how to make it stick", Camilla Krabbe Kongsted Christensen, Business Development Consultant, NNIT Wednesday October 10, 16.15-17.15, Keynote track "Entrepreneurship and Digital Transformation as driving forces for growth and job creation", Jens Maagøe, CTO, NNIT Date and Time TBA, Internet of Things track "Internet of Me", Massimo Caterino, Principal Consultant, NNIT You can read more about NNIT Corporate Entrepreneurship here. About the event A unique trade fair and conference! High Tech Summit is part conference and part exhibition powered by DTU (Technical University of Denmark). Our vision is to create the largest research-based meeting place in Denmark within the fields of digitalization, robotics and artificial intelligence. The summit takes place over two days in October 2018 and aim to create the perfect environment for companies, start-ups, organisations and universities to meet and present their latest technological developments, debate the most recent discoveries, participate in matchmaking events, and generate ideas. Registration is free and will open in early September 2018.
24th Annual Validation Week Annual Validation WeekOct 22-24 | San Diego, CA NNIT is exhibiting and presenting at IVT's 24th Annual Validation Week in San Diego, CA.About the conference Convening validation professionals of all levels for unmatched training, the Validation Week provides a transformative exploration through the world of validation. Build your own conference adventure and trek your way between four unique tracks — Process Validation, Quality, CSV/Data Integrity and Cleaning Validation. Navigate the critical aspects of validation with subject matter expert trailblazers and uncover a wide range of solutions to your organization’s specific challenges. Read more about the conference here...About the presentation Director at NNIT, Raymond McKinney will be giving the presentation Cutting Costs While Improving Quality in Validation using Robotic Process Automation on the CSV/Data Integrity Track during Validation Week. The presentation agenda consists of Introduction to Robotic Process Automation (RPA) Automated software testing using RPA tools Accelerating & error-proofing repetitive tasks using RPA tools Using RPA in regulated environment Live demos and excersices
Conference: 2018 ISPE Annual Meeting & Expo 2018 ISPE Annual Meeting & ExpoNovember 4-7 | Philadelphia ​NNIT look forward to meeting you at ISPE Annual Meeting & Expo in Philadelphia. Visit our booth for an informal talk about how we can assist you in transforming your digital journey. The Life Sciences industry is under constant transformation and many companies are now starting to embrace digital transformation. NNIT sees digital innovation as a prerequisite for digital transformation, and we are together with our clients finding new ways to tackle the challenges in the industry. For instance, due to increasing regulatory demands, computer validation and IT compliance have become more time and resource consuming. This is why we has developed NNIT Compliance as a Service that enables you to be compliant at any stage without worrying about resources, skills, upcoming regulations etc. We also work with Robotic Process Automation to help our clients automate repetitive and time-consuming tasks. Increasing regulatory requirements have also fostered a silo-based application landscape. This landscape doesn't support true end-to-end regulatory and safety activities and the changes within the regulatory environment (e.g. transparency). The growing demand for data sharing (across applications) and oversight (internal & external) suggests a revision of the Regulatory Architecture. A solution to this is an RA Information Catalog that provides you with search capabilities and instant access to data. About the conference The 2018 ISPE Annual Meeting & Expo will focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing across the globe, offering pharma professionals the opportunity to engage in industry-critical conversations. A comprehensive education program provides attendees with technical sessions on the latest developments in Supply chain Facilities & equipment Information systems Product development & production systems Quality systems & regulatory oversight Cutting-edge industry innovations. Read more about the conference here...
Nordic Blockchain Conference Blockchain ConferenceNovember 16 | Dansk IndustriNNIT invites you to join us at the Nordic Blockchain Conference this November, and learn how Blockchain solutions can add value to your business. About Nordic Blockchain Conference Nordic Blockchain Conference is a one-day event, where you will be able to learn how blockchain actually functions in an industry-specific context. In addition, you will learn how blockchain can become an asset and generate value for your business, meanwhile learning about the implications connected with implementing Blockchain into your business. At the conference industry experts and Blockchain enthusiasts will discuss the value of Blockchain as a tool, as well as examples of successful implementation and innovation of the technology. The conference will provide you with the necessary information to decide whether blockchain fits your business or organization. Interested? NNIT provides you with an exclusive 50% discount Fill out our webform below to participate in the first Nordic Blockchain conference, to meet like-minded professionals and potential clients. The discount is provided on a first-come, first-serve basis. Sign up to secure your exclusive discount. Read more about the conference Sign up here
Conference: Computer Systems Validation & Data Integrity Compliance Congress Computer Systems Validation & Data Integrity Compliance CongressDec 3 -5 | Washington D.C. The FDA has issued many Warning Letters emphasizing CSV non-compliance. These serious findings include; having interrupted, missing, deleted and lost data; inadequate records for risk analysis; failure to exercise appropriate controls; failure to validate computer software; failure to establish validation procedures; manipulation and deletion of audit trails; and many more. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures. NNIT has many years of experience with CSV as well as DI and will be exhibiting at this congress taking place in Washington D.C. The congress will focus on the below subjects. Computer Systems Validation Conduct a CSV Audit Enterprise-Wide and Develop a Master Plan Perform Risk Assessments on Complex Systems Understand Documentation Requirements for Validation Confirm Accurate Processing, Control and Reporting of Electronic Records Develop an Effective CSV Corrective Action and Preventive Action (CAPA) Program Audit and Validate Paper, Electronic and Hybrid Systems Streamline Processes with Innovative E-Validation Solutions Write IQ/OQ/PQ Procedures, User Requirements and Test Scripts for New Systems Learn Best Practices for Change and Configuration Management Qualify Cloud Infrastructures & Mobile Devices Understand How to Validate Excel™ Spreadsheets Data Integrity Compliance Develop, Implement and Maintain Data Integrity Protocols Enterprise-Wide Learn the Methodology and Techniques Used to Identify Inaccuracies Conduct an Audit Enterprise-Wide Ensure the Reliability and Completeness of Analytical Data Identify and Investigate Root Causes of Integrity Lapses Cybersecurity Risk Management Implementation and Continued Verification Perform a Risk Assessment for Deficiencies Understand Requirements and How to Handle Audit Trails Personnel in the Following Environments Should Attend Validation QA/QC Engineering IT Quality Control Manufacturing Management Laboratory Management Regulatory Affairs