Managing Risk for Clinical Trials

Managing Risk for Clinical Trials - Webinar CD/Transcript

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Managing Risk for Clinical Trials: Incorporating Quality by Design and Risk Management Strategies

Among the many issues that can derail a clinical trial, quality failures are surely the most frustrating.

Why? Because risk management techniques exist that can help you detect and mitigate the risks that can lead to clinical trial failures.

Those undetected flaws in your design and development process are preventable if, early in a trial, you incorporate risk management strategies such as Risk Management Plans and Quality by Design (QbD) tools.

The real question is: What are you waiting for?

The FDAnews webinar CD and transcript Managing Risk for Clinical Trials: Incorporating Quality by Design and Risk Management Strategieswill help you make that critical choice.

With more than 50 years of combined experience, expert presenters Sherri Hubby and Brian Nugent share insights that can be used to establish Risk Based Monitoring Plans, including triggers for return to 100% source data verification. 

Even better, they show you how to proactively identify and manage risks to your trial with methods that can immediately be implemented and used.

You find out about QbD examples such as failure-modes-and-effects and criticality analysis (FMECA), Isikawa/Fishbone Diagrams, and Hazard Analysis and Critical Control Points (HACCPs).

 And you learn these specifics:

  • 10 factors to consider when evaluating risk-based monitoring for clinical trials
  • 6 triggers for moving from on-site monitoring to centralized monitoring
  • 7 warning signals that suggest increased source data verification is needed at an investigator site
  • 6 elements of a site level risk-based monitoring plan
  • Best practices from successful programs that are actively using centralized risk-based monitoring
  • The "5 why" approach to prospectively identifying the root cause of a non-compliance systemic issue
  • Tips for establishing an effective risk management system culture within your organization
  • And more!

Ordering the Managing Risk for Clinical Trials: Incorporating Quality by Design and Risk Management Strategies webinar CD and transcript might be the best decision you make in 2014.

After all, Risk Management Quality by Design (QbD) Strategies are encouraged by regulators such as the FDA and EMA.  In fact, the QbD process was first introduced by the FDA — and is considered an important process and systematic approach to achieve clinical success.

  • Clinical trial directors
  • Medical affairs directors
  • Compliance officers
  • Project and clinical managers
  • Regulatory affairs professionals
  • Risk management specialists
  • Study monitors
  • Study research coordinators
  • Study sponsors and contract research organizations
  • Training personnel
  • Personnel new to the industry

Meet Your Presenters
Sherri Hubby began her career in clinical research in December 1998 as an FDA investigator responsible for conducting inspections of Clinical Investigators, IRBs, pharmaceutical, medical device, software and blood banks.  Sherri has also served as the Human Research Protection Program Manager for an IRB to help them become accredited. 

Sherri joined Premier Research in June 2008 as Director of Quality Assurance for the US and is responsible for implementing the Quality Management system to ensure compliance. Her specialized experience includes conducting directed audits and performing FDA and EMA Mock inspections with pharma, CRO and investigator sites.  Sherri is a frequent speaker at the U.S. Drug Information Association (DIA) and DIA Euro Meeting.

Brian  Nugent has spent over 30 years in health care and 15 years in the drug development industry spanning both biopharmaceutical and CRO organizations with Director level responsibility for quality, clinical operations, process development, TMF and safety. 

Over the past several years Brian has concentrated his efforts on clinical operations process development and the building of quality systems to include QRM and QbD, as well as the establishment of risk management standards and plans.