Overview:
The webinar will cover what it takes in conducting an effective recall. You will learn practical knowledge on how to work with FDA staff during a recall, and how you can prepare for inspectional follow up or a regulatory action. You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business.
As part of risk assessment, utilization of FDA's health risk criteria (Health Hazard Evaluation) will be discussed so that you can develop incorporate them into our recall procedures. Identification of the root cause of the recall prevents that problem from happening again. We will discuss how to utilize CAPA to prevent the issue to re-occur.
Why should you Attend: Product recalls impact all businesses at one time or another. It is important to establish a good plan and strategy to gain the confidence of your customer and regulatory body that the issue has been identified and a good plan to correct, remove or withdraw has been put in place accordingly.
This webinar will provide you knowledge to establish a plan for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy.
Areas Covered in the Session:
The webinar will cover what it takes in conducting an effective recall. You will learn practical knowledge on how to work with FDA staff during a recall, and how you can prepare for inspectional follow up or a regulatory action. You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business.
As part of risk assessment, utilization of FDA's health risk criteria (Health Hazard Evaluation) will be discussed so that you can develop incorporate them into our recall procedures. Identification of the root cause of the recall prevents that problem from happening again. We will discuss how to utilize CAPA to prevent the issue to re-occur.
Why should you Attend: Product recalls impact all businesses at one time or another. It is important to establish a good plan and strategy to gain the confidence of your customer and regulatory body that the issue has been identified and a good plan to correct, remove or withdraw has been put in place accordingly.
This webinar will provide you knowledge to establish a plan for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy.
Areas Covered in the Session:
- Understand FDA's recall authority and policy
- Learn how to manage recalls under FDA oversight
- Learn how to interact with FDA
- See how to develop health risk determinations
- Learn critical recall strategy component
Speakers
Swasita Saigal,
Who Should Attend
- Post Market Regulatory Affairs Manager
- Recall Managers
- Quality Assurance Managers
- Regulatory Affairs Directors
- Risk and Product Liability Managers
- Manufacturer's Sales and Marketing Managers
