Once again last year, failure investigations topped the list of citations in FDA Form 483 reports and warning letters. And it’s no wonder – they’re among the most difficult and frustrating tasks that fall to pharmaceutical quality units. Yet conducting these investigations properly is the key to identifying and eliminating the root causes of compliance failures, patient risks and corporate turmoil.

Often this means tackling the mother of all root causes: Variability.

After ruling out microbial contamination, McNeil Consumer Healthcare inexplicably closed out its first root cause investigation of malodorous Tylenol bottles. The discovery that a wood pallet preservative was responsible came the next year, as did the Form 483 reports, the warning letters, the congressional hearings and the management shake-ups.

So confident was Claris Lifesciences in its leak detection methodology that it disregarded complaints by Pfizer and other customers that fungi and bacteria had infiltrated IV bags of sterile injectables it had manufactured for them. Despite Claris’ confidence, FDA sent the company a warning letter and banned imports.

But persistence can pay off. It took Amgen eight months to identify the root cause of glass vial breakage at one of its plants. In the end, the key was a statistical analysis of multiple variables that identified the problem: a change in oven temperature at a glass vial supplier. When you run into a quality issue you can’t explain, a lot will be riding on your mastery of the root cause investigation process – patient safety, company reputation, maybe even your job.

In this session, you’ll learn the components of a successful root cause investigation, including how to:

• Use a closed loop process to go from problem statement to likely root cause;
• Appropriately use expertise/process and inference/facts when investigating;
• Utilize tools that organize and guide investigations;
• Collect and use data that supports an investigation;

For one low price, you and your entire team can take part in this fast-paced, insightful webinar. Best of all, you’ll be able to connect personally with our speaker, George Bernstein, when we open up the phone lines for live Q&A.