Root cause analysis of failure and CAPA
Course objectives and benefits
This workshop intends to give you an insight into the methods to be followed for effective Failure Investigation and Root Cause Analysis for different types of failures, e.g. GMP-related deviations, market complaints, OOS/OOT results, etc. This workshop would also discuss how we can identify appropriate corrective and preventive actions (CAPA) following risk management principles.
Regulatory expectation in this area will also be covered along with documentary requirements. This workshop is designed to be highly interactive; along with these theoretical aspects, several practical case studies will be discussed.
Participants will get an opportunity to work hands-on on practical exercises related to root cause identification, risk analysis and corresponding CAPA.
An opportunity to interact with industry contemporaries and see your situation from a different persepctive.
Learn how the industry is coping with their problems.
Get guidance from industry expert with loads of experience.
Deviation Failure Investigation CAPA
Course objectives and benefits
During manufacturing of any drug or product to be used for the manufacturing of medicinal products failures in respect to pre-defined conditions can occur. Basically this will not immediately cause to disturb the product but actions have to be taken to invest on the reason of this issue and to correct the failure. Finally it is expected to take decisions on how to prevent the re-occurrence and implementing actions to prevent the occurrence of any possible failure in relation to the deviation working on. CAPA is one of the most need observation by the FDA not to have implemented the correct system or not acting sufficiently on the actions to be taken.
Deviations and failures are the cause for initiating CAPA. How to act on failures? How to investigate the failure? What actions have to be taken (CAPA) finally to close the process? How to check the effectiveness of the measurements taken.