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FDAnews Announces -- Managing Risk for Clinical Trials: Incorporating Quality by Design and Risk Management Strategies Webinar, Sept. 9, 2014

August 19, 2014



Falls Church, VA (PRWEB) August 19, 2014

Managing Risk for Clinical Trials:

Incorporating Quality by Design and Risk Management Strategies

**FDAnews Webinar**

Sept. 9, 2014 -- 1:30 p.m. 3:00 p.m. EDT

http://www.fdanews.com/ManagingRiskforCT

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 detect and mitigate the risks that can lead to clinical trial failures.

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

On Sept. 9, the FDAnews webinar Managing Risk for Clinical Trials: Incorporating Quality by Design and Risk Management Strategies will help attendees make that critical choice.

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

Even better, they'll show attendees how to proactively identify and manage risks to trials with methods that can immediately be implemented and used.

Attendees will 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 attendees will 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

And more! BONUS: During the session, attendees will also receive a copy of an invaluable risk assessment process/checklist to apply to the selection of vendors. Attending Managing Risk for Clinical Trials: Incorporating Quality by Design and Risk Management Strategies might be the best decision made 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. Meet the 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.

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. Who Will Benefit:



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

Webinar Details:

Managing Risk for Clinical Trials:

Incorporating Quality by Design and Risk Management Strategies

**FDAnews Webinar**

Sept. 9, 2014 -- 1:30 p.m. 3:00 p.m. EDT

http://www.fdanews.com/ManagingRiskforCT

Tuition:

$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:

Online: http://www.fdanews.com/ManagingRiskforCT

By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at http://www.prweb.com/releases/FDAnews/ManagingRiskforCT/prweb12103237.htm


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