REGISTRATION

October 27, 2022, 11am-1pm ET, Virtual

The goal is to make more products faster and more efficiently, without sacrificing quality.  Before implementing change, you need to answer several core questions, including:  How can I intensify an established process with minimal risk?  Why should I change a working, validated process? What are the appropriate technology options and what metrics should be considered to justify their investment?  

Our speakers provide insight on their experiences, decision-making processes and outcomes.

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Meeting Agenda (subject to change)    

Moderator:                  John Bonham-Carter, Vice President Business Development and Product Management, Erbi Biosystems    

11:00 am – 11:30 am    Meet and Greet Networking + Welcome

11:30 am – 11:50 am    Case Study 1: Changing Technologies Within an Established Manufacturing Process (Arthi Narayanan, Innovation Team Leader, Pharma Technical Operations, Genentech)

* How to upgrade technologies within existing process 

* What’s the justification – Why bother 

* How good does the improvement have to be to justify investment 

* Factoring in regulatory considerations 

* Satisfying internal and FDA regulatory concerns 

11:50 am – 12:10 pm    Case Study 2: Justifying the Process Change

* Why change a working process

* What’s the incentive/motivation

* How to justify the investment

* Critical data needed to support your decision

* Managing expectations  

12:10 pm – 12:30 pm   Case Study 3: Leveraging Established Processes - Intensifying with Minimal Risk

* How to decide on intensification for one product vs. continuous for another 

* What factors must be considered to make the best decision 

* Leveraging data/knowledge from sites using different techniques.  Assessing performance. 

* What metrics should you use to determine/decide * Lessons learned

12:30 pm – Close        Deep Dive Networking  

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