Presented by: Joscelyn Bowersock, Customer Success Manager, L7 Informatics Part 1 – The Change Control System• Why is a change control system needed?• When does the change control system need to be implemented?• Project change control versus quality change control• Review an example of generic change control process flow• Paper versus electronic change control systems […]

Presented by: Cheryl Bondurant, Principal Consultant, CAI In 5 years, 10 years from now what will the Biotech industry look like? What will the expectations be for the health and safety of our public … and how can our Quality Systems affect this? In this session you will learn how we can make our Quality […]

Presented by: David Shenberger, Vice President, Consulting Services, CAI This session will start off by addressing what speed to patient really means and how important operational readiness is to deliver high-quality medicines in a timely manner. We’ll take a quick look at how all the workstreams come together to deliver products. And then, we’ll dig […]

Presented by Karen Zimm, Associate Director for Janssen Pharmaceuticals and Renée Phillips, Associate Director of Global Regulatory Affairs at Janssen Research & Development Top Reasons to Attend: • What does FDA continuously cite on 483?• Why does industry make the same mistakes over and over?• Possible systemic reasons• Contributing factors CGMP’s – Why Are We […]

Why a QRM Approach to C&Q?• Understand QRM as a holistic process, and how to apply it to C&Q• Understand the regulatory and industry drivers• Learn the benefits: scope, schedule, cost, effort, speed to marketRisk Assessment and Risk Control Through Design and Verification• Use PPK – CQAs and CPPs – as the basis for QRM• […]