Online Webinar 2019 - Building a World-Class Drug Supply Chain Tips for Compliance and Digital Transformation

Session Highlights
Lessons learned from FDA’s DSCSA implementation and pilot
What the next few years will look like for manufacturers, wholesalers and dispensers
How to establish and implement a solid foundation and baseline for digital supply chain and the digital transformation process
Strategic planning and realizing the return on investment and benefits
Discuss some of the new technologies (e.g., Internet of Things) that will define categorically supply chain capabilities
Ensure your company has the tools it needs to be at the forefront of this digital transformation of health information management and the drug supply chain
Who Will Benefit
Digital Transformation Leaders and SME’s
Regulatory Affairs
Executive Management
Operational Executives (Head of Supply Chain, Head of Manufacturing)
Serialization Project Leads
Supply Chain/Operations personnel
Packaging/Engineering Managers/Leaders
QA/QC personnel
IT Managers, IT Business Partners
Overview
Passed in 2013, the Drug Supply Chain Security Act (DSCSA) gives the Federal Drug Administration (FDA) more control over the manufacturing of drugs in the United States. Starting in 2015, with full compliance by 2023, most pharmaceutical drugs now must be traced, verified, and serialized for the entire supply chain, from manufacturer to pharmacy. The supply chain regulatory deadline of 2023 will be here soon; however, now is the time for all industry stakeholders, manufacturers, wholesalers, distributors and dispensers, to take a step back and plan strategically. Now is the time to begin preparation and understand the process regarding digital supply chain with track-and-trace capabilities. Companies in the drug supply chain should be looking not only at the trace and track software but should also be looking very closely at choosing the right computational backend as well. As the healthcare business intelligence grows, so does its potential, creating a situation where choosing the right back-end can become as important as the front-end software decision. Furthermore, revisit FDA’s Guidance - Drug Supply Chain Security Act Implementation and understanding the fundamentals, including identification of suspect product and the notification process and much more.
Instructor Profile
David R. Dills, Independent Regulatory & Compliance Consultant, with an accomplished record has more than 22 years of hands-on experience with emphasis on Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of QA, Regulatory Affairs and Compliance. Since 2000, has provided consultative services on behalf of global manufacturers and subcontracted by third-party consultancies and provides services involving all key stages of the product development, submission, and commercialization process, inspection readiness preparation, GxP compliance, execute audits and regulatory assessments, execute remediation and regulatory strategies, postmarketing surveillance/vigilance reporting, clinical affairs, deploy and remediate QMS and documentation systems, preparation for ISO 13485 registration and CE Mark, and multi-country device registrations. He has been previously employed, with increasing responsibilities by medical device firms and consultancies, including a globally recognized CRO.