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Pre-Conference Workshops

Tuesday January 28, 2020

Workshops should be selected separately from the conference only option at registration  

Workshop A

Process Design & Development: KPIs and CQAs of Continuous Manufacturing

9:00 am to 12:00 pm

Process design and development remain a critical element of a success continuous manufacturing. This session will be catered for both small molecules and biologics attendees, and through in-depth discussion and scenario case study, you will be able to apply the following after this short course:

• Apply QbD to process design and development for continuous manufacturing

• Understand the difference between legacy product and novel molecule filing

• Equip with transferrable skills between small molecules and biologics, and drug substance vs drug products

• Define your product's critical quality attribute and integrate this as part of your process design and development plan

• Verification is key: proof of concept and verification testing

Modern Pharma - Ian Leavesley

Ian Leavesley
President
Modern Pharma Consulting

Codiak Bio - Joon

Joon Chong Yee
Associate Director, Upstream Process Development
Codiak BioSciences

Workshop B

Process Design & Development: KPIs andCQAs of Continuous Manufacturing

9:00 am to 12:00 pm

Over the last few years we have witnessed the maturity of continuous manufacturing with a lot of pilot projects now going through scale-up, and from lab to commercial implementation. This can obviously be a pivotal moment a milestone for the project team but can also be a challenging one.

Ernie is an experienced continuous manufacturing expert and he’ll be leading this session to give you a practical step-by-step guide on how to execute this. Through open discussions and scenario-based exercise, you will be able to:

• Account for critical factors during the scale-up and commercialization

• Appreciate the differences and variables of CM in lab and commercial scale

• Engage and involve the right stakeholders to ensure project sponsorship and support

• Define the appropriate and optimal timeline for your project, as well as critical milestones you need to check in

• Re-assess if you are ready to scale up

• De-risk any potential pitfalls

EJH Consulting - Ernie H

Ernie Hillier
Founder
EJH Consulting