Workshop Day

9:30 am - 10:00 am Registration and Coffee

Join this interactive workshop to:
• Address your hot topics and challenges with an industry expert 
• Benchmark with an intimate working group
• Discuss best practices in navigating the regulatory GMP landscape over the end to end lifecycle of your combination products
• Leave with concrete strategies to apply in your everyday role

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Susan Neadle

Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design
Johnson & Johnson

1:00 pm - 2:00 pm Networking Lunch


2:00 pm - 5:00 pm Workshop B - Using Design Controls to Aid in the Development of Combination Products

Sanjay Jain - Associate Engineering Director, Device, Janssen
Join this interactive workshop to:
• Document the structure and basic principles that aid in project planning, development, execution and life cycle management
• Gain an understanding of the rules and regulations, and merging pharma and medical device
• Explore using quality systems to develop combination products 
• Discuss the synergistic effects between device mode of actions and drug mode of action and their impacts on development plan
• Review a hypothetical product to come up with a development plan – what are the key elements that need to be incorporated?
• Leave with an understanding of how design controls influence development 

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Sanjay Jain

Associate Engineering Director, Device
Janssen

5:00 pm - 5:00 pm End of Workshop Day