Description
How do you prevent becoming another FDA statistic? Poor corrective and preventive action (CA/PA) and investigations continue to be among top FDA Form 483 deficiencies issued to drug, biologic, and medical device manufacturers. It`s in everyone`s self interest to improve the quality of investigations and CA/PA. This webinar will provide regulated companies the core principles and practices needed to implement an effective and efficient CA/PA process.
This presentation will begin by defining risk in compliance and the methods, which can be used to mitigate risk. One of the methods defined by the regulators and the industry is "Corrective Action / Preventive Action" otherwise referred to CA/PA. We will first define what we mean by risk. We will then explore the factors associated with risk in compliance. We will also explore risk causing events and how to address them. A review of risk severity/level will then ensue. Upon completion of risk part of the presentation we will define what a CA/PA system would look like. Finally an overview of a CA/PA system will be presented and a CA/PA approach will be proposed. The approach will focus on defining the specific steps to be taken when implementing a CA/PA system and review some of the possible pitfalls one may encounter when implementing a CA/PA system.
