Validation Sampling Plans, Setting Acceptance Specifications, and Statistical Process Control

Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.

Regulatory agencies expect statistically justified sampling plans as well as statistically justified acceptance criteria. In this presentation, we will discuss a 5 step approach to setting up sampling plans, and using those sampling plans to set appropriate acceptance criteria for process validations. We will discuss a risk-based approach to determine sampling and confidence levels needed depending on the validation and risk of release of non-conforming product.

After a process is validated, it is important to ensure it is maintained in a validated state. We will discuss the tools available using statistical process controls to provide continual monitoring of the process to ensure that is continues to perform as validated and to be able to take proactive measures if the date shows adverse trending.

Why should you Attend:
This webinar will be useful to validation engineers, R&D scientists, quality professionals and production personnel involved in validation activities. Validation professionals in both medical device and pharmaceutical industries will benefit. Setting up sampling plans is a joint effort between the above team members who each bring a part to the table. An understanding of how to set up appropriate sampling plans and setting appropriate acceptance criteria is critical to a successful validation.

I don't do FUD.

Areas Covered in the Session:

• What is sampling
• Validation sampling vs lot acceptance sampling
• Setting up a validation sampling plan: 5 step method
• Using sampling plans to set acceptance criteria for process validations
• Use of process capability to set acceptance criteria
• Statistical process control and maintaining a controlled state

• Quality Assurance Professionals
• R&D Scientists
• Technical Support Scientists
• Regulatory Affairs Professionals
• Manufacturing and Production Personnel Involved in Validation Activities
• Both Pharmaceutical and Medical Device Professionals are Appropriate