Filling the Gap - How Digital Transformation should be embraced when Building your Next-Generation Labeling System
Sponsored by: PRISYM ID
- Digital Transformation
Date: 27 June
Time: 4PM London/11AM New York
Labeling Webinar Series - A Date with the Experts on Global Labeling Systems
For Life Sciences organizations designing a next generation enterprise labeling system, consideration must be given to the gap between today’s operational requirements, and the possible demands of the organisation, its customers and the market environment in years to come.
Anticipating and incorporating these future requirements is challenging, but by considering the current trends in digital transformation, insight into future business models and requirements can be gained.
It’s time to step back from your current processes and systems and start looking at the bigger picture. By evaluating the wider business strategy, identifying current operational bottlenecks, understanding the future regulatory landscape and challenging internal perceptions, you can embrace a new way of working and recognize how new technologies can support your organization.
Join us for the second of our 60-minute webinar series, featuring leading industry experts who will discuss how digital transformation should be embraced and why your user requirements must reflect the long-term strategy for your business to ultimately drive efficiency and reduce costs.
Azimuth Compliance Consulting
Kevin Bogert has become an information technology, project management, quality, regulatory, clinical, and validation expert during more than 25 years holding leadership roles within the life science industry and as an independent compliance consultant. His background includes software development and implementation, preclinical/clinical, quality management, regulatory affairs, and computer and process validation.
Kevin holds a master’s degree in Systems Management and a bachelor’s degree in Business Management/Computer Science. He has also completed numerous certificate programs and graduate coursework in international regulatory affairs, quality management, clinical trials, lean six sigma, and applied statistics. Kevin has served on the PhRMA Statistics and Validation Committees (predecessor to ISPE GAMP), the SAS Users Group, and as a member of the American Society for Quality and Regulatory Affairs Professional Society.
Tim has spent over 25 years in and around Life Science compliance. Having launched his career at Abbott Labs in the Hospital Products Division in North Chicago, he spent most of his early days within Biological QA/QC as well as Small Volume Parenteral operations management. He then did additional technical work.
Following his Abbott days, he worked as Director of Compliance for 3 CMOs and in 2007 decided to strike out and perform 21 CFR 820 quality system consulting. It was during this period that he developed an appreciation for compliance software of which he has been heavily involved in over the course of 6 years including with PRISYM ID.
Key Learning Objectives
- What to consider when developing the user requirements (URS) for your next-generation labeling system
- How to break down silos within your processes by using integrated technologies, automation and digital innovation
- Why building innovation and flexibility into your labeling processes will improve your ability to respond to compliance and industry changes
- How reviewing the latest technologies including cloud based models could drive efficiency and reduce costs
- Manager / Head / Director / VP of Labeling and Packaging
- Manager / Head / Director / VP of Manufacturing
- Manager / Head / Director / VP of Regulations
- Manager / Head / Director / VP of Quality
- Manager / Head / Director / VP of Compliance
- Manager / Head / Director / VP of Logistics
- IS / IT Managers / Heads / Directors / VP