Thursday March 28, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Danielle DeLucy
Why You should Attend The Session
If you have reoccurring problems showing up in your quality systems, your Quality system is not effective and you have not performed an in-depth root cause analysis to be able to detect through proper problem solving tools and quality data sources, the true root cause of your problem. Unless you can get to the true root cause of a failure, nonconformity, defect or other undesirable situation, your Quality System will not be successful. Historically, 483s in the pharmaceutical industry related to CAPAs, are due to lack of inadequate root cause investigations, among other factors.
Description Of The Topic
In many companies, deviation/non-conformance investigations are often criticized for the lack of a robust root cause analysis. Proper root cause can help a company in many ways.
Root cause analysis helps identify what, how and why something happened, thus preventing recurrence. Root causes are underlying, are reasonably identifiable, can be controlled by management and allow for generation of recommendations. The process involves data collection; cause charting, root cause identification and recommendation generation and implementation.
Areas Covered During The Session
(Bullet Points) Upon completion of this seminar, one will be able to:
- Know what to do when problems occur.
- Define, validate and decide if the problem should be solved.
- Use a team approach and understand team dynamics.
- Take appropriate interim actions.
- Choose the most appropriate RCA methods for the situation.
- Determine and implement the best sustainable solution.
Target Industry Pharmaceutical, Medical Device, Clinical, R&D, Biologics, Generics
Target Job Title Site Quality Operations Managers
Quality Assurance personnel
Plant Managers and Supervisors
Manufacturing Superintendents and Managers
Regulatory Affairs Managers
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-582