Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced Manufacturing Conference and Supply Chain Summit, in partnership with Axendia, Inc. The two events will run back-to-back with registration options available for each program as well as a discounted rate for professionals who would like to attend both programs.
Both events will be held at the offices of Hogan Lovells in Washington, DC.
The MedTech Intelligence Advanced Manufacturing Conference will bring together leading MedTech executives and regulators for an in-depth look at the value of adopting advanced manufacturing technologies. Learn how advanced manufacturing supports improved quality, speeds time to market, and helps tackle labor shortages.
Session highlights include:
What Does Advanced Manufacturing Mean to MedTech?
The industry perspective on innovative technologies and processes to improve the efficiency, quality, and competitiveness of manufacturing in MedTech.
Presented by: Garth Conrad, Vice President – Quality, Flex Health Solutions
Regulatory & Quality Frameworks for Advanced Manufacturing
The industry perspective: leveraging regulatory & quality frameworks to drive advances in manufacturing.
Presented by: Hugo Felix, Director, Medical Device and Combination Products, Pfizer
Real World Success Stories – Computational Modeling & Simulation
How to use mathematical and computational approaches to replicate and analyze complex systems.
Presented by: Payman Afshari, PhD, Sr. Principal Engineer, Depuy Synthes – Johnson & Johnson
Goodbye Computer System Validation, Hello Computer Software Assurance!
The FDA, recognizing industries CSV challenges, released the long-anticipated Draft Guidance on Computer Software Assurance for Production and Quality System Software in September 2022. This session will explore the impact of this guidance on advanced manufacturing.
Presented by: Daniel Walter, CSA & Advanced Manufacturing, CDRH OPEQ FDA
Do or Do Not…There is No Try in Digital Transformation
The role of Good Technology Practices in support of digital sustainability.
Presented by: Sandra Rodriguez, Sr. Industry Analyst, Axendia
The MedTech Supply Chain Intelligence Summit will offer insights and strategies from MedTech executives and regulators on overcoming current challenges and preparing for future supply chain risks. Learn how your peers assess and mitigate risks, improve logistics, and build sustainable, resilient supply chains.
In-person and virtual registration options available.
Session highlights include:
Overcoming Supply Chain Challenges & Seizing Opportunities
Panelists: Hugo Felix, Director, Medical Device and Combination Products, Pfizer; Garth Conrad, Flex Health Solutions; Robert Nunez, Sr. Director of Reliability, Ethicon, a J&J Company
Challenges of Executing Risk Management for Combo Products in a Global Supply Chain
This session will address risk management execution for combination products and the challenge associated with varying global definitions of combination products and inconsistent application of requirements, especially in lifecycle management. These trends call for a new paradigm in global supply chain management.
Presented by: Hugo Felix, Director, Medical Device and Combination Products, Pfizer
Digital Transformation – Efforts at FDA CDRH
Elizabeth McNamara, Associate Director, Office of Digital Transformation, CDRH, FDA
Supply Chain Visibility: A Regulatory Necessity and Business Imperative
Why shifting from Rigid Supply Chain to Value Networks is a MUST: The Analyst perspective based on primary market research.
Presented by: Daniel Matlis, President and Founder, Axendia
Managing Supply Network Risk – A CMO Perspective
Mitigating supply chain risk in the age of continuous disruptions requires CMOs/CDMOs to operate with a high degree flexibility.
Presented by: Presented by: Garth Conrad, Vice President – Quality, Flex Health Solutions
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