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Agenda
Speakers
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Home
Agenda
Speakers
Handouts

GMP Quality Management vSummit 2023

Where Quality Meets Risk

An FDAnews Virtual Summit
Wednesday, Oct. 11 to Thursday, Oct. 12, 2023

Agenda

Time Zone Preference

Wednesday, October 11, 2023

10:00 AM

Welcoming Remarks

10:15 AM

Keynote Address – Enhancing Agility in Quality Management

11:00 AM

Quality Management Maturity – Pharmaceutical Principles and Priorities

11:45 AM

Making the Case for Quality – Voluntary Improvement Program

12:30 PM

1:00 PM

The Intersection of Risk and Quality – Implementing ICH Q9

1:45 PM

Updating Device Quality Regulations – What (and When) to Expect of the New QMSR

2:30 PM

3:30 PM

3:45 PM

Thursday, October 12, 2023

10:00 AM

Recap of Day 1 and a Look Ahead to Day 2

10:15 AM

Finding Common Ground – Drug and Device Risk Management for Combination Products

11:00 AM

Mending the Supply Chain – Overcoming Shortages

12:00 PM

12:30 PM

Building a Culture of Quality from the Top Down – A Companywide Attitude of Excellence

1:15 PM

The Nuts and Bolts of Continuous Improvement

2:00 PM

2:15 PM

Quality Metrics – How Do You Measure Quality

3:00 PM

Quality Management in the Trenches – Case Studies and Best Practices

3:45 PM

Summit Q&A & Wrap-Up

4:00 PM

Summit Adjournment

(UTC-04:00) Eastern Time (US & Canada)

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