Accelerate & Optimize Clinical Development: Risk Based Quality Management


February 8


12:00 pm - 01:00 pm

Event Category:


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Hughes BioPharma Academy with Dr. Candice Hughes

Website: Organizer's Website

Online Event

How can you have clinical trials that are better & faster with less burnout? Register Today.

You’ll learn real world methods Dr. Hughes has honed as a consultant for 2 decades with Fortune 500 biopharma firms to startup biotechs.

This presentation is an updated and enhanced version of an invited lecture Dr. Hughes presented at ASQ (American Society of Quality).

You’ll learn:

1. What is risk-based quality management (RBQM)?

2. What are global regulatory standards for risk based quality, for example, ICH E6(R2)

3. How can you use RBQM to make processes at your firm more efficient and effective?

4. How can you identify & track which aspects of your clinical trial that have the most impact on risk?

5. What are Key Risk Indicators & Quality Tolerance Limits?

6. Your Take Away from attending this session is: Increased success with submissions, lower cost, improved quality, shorter timelines.

Who is your professor, Dr. Candice Hughes?

Dr. Hughes has been hired by half of the world’s largest biopharma firms as an operations and compliance expert to develop and get their innovations to market faster. Dr. Hughes is CEO and Founder of Hughes BioPharma Advisers, a 20 year old management consulting firm. She has 30 years of experience as a scientific, quality and compliance expert in biopharma. She is a certified Risk Management Professional (CRM)) with a PhD in neuroscience and human anatomy. Dr. Hughes has an MBA that includes focus on process optimization and technology innovation.

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