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Subscribe NewsletterEffective & Essential CAPA process to avoid FDA 483
Product Id
:
600270
Overview: 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.
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.
Areas Covered in the Session:
- FDA Inspection trends related to CA/PA
- CAPA data sources
- Elements of a successful CA/PA system
- Integrating risk management
- How to document
- How to Investigate and determine severity
- How and what to track - lifecycle management
Who Will Benefit: This program is designed to introduce Life Science technicians and professionals to the fundamentals of Corrective Action / Preventive Action as a risk mitigating tool. The discussions would be beneficial to personnel involved in manufacturing, compliance and engineering including:
- Technical Services
- Manufacturing and packaging
- Engineering
- Facilities Services and Maintenance
- Validation
- QA/QC