Thursday, July 14 | 11:00AM ET
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 into the quality workstream. What is quality’s role? How can quality make every other workstream better? The ICH guidelines provide quite a bit of background on the quality role and this session will integrate quality risk management and quality system guidelines into the discussion.
Top Ten Benefits
Attendees will:
- Gain an understanding of the complexity of delivering products in a regulated environment
- Explore the guidelines provided in ICH Q8, Q9, and Q10
- Explore practical application of regulatory requirements for the quality organization
- Review the workstreams in a standard pharma organization, understand their roles, and how quality interacts with each.
- Be familiarized with the quality organization’s audit role
- See the impact of quality risk management on speed to patient
- Understand the importance of early project planning
- See the criticality of stakeholder involvement in early project planning
- Experientially follow a project timeline from concept to production
- Understand the terms operational readiness and operational excellence
