🎤 Alan M. Golden | 📅 November 6, 2024 | 🕒 11 AM Eastern Time US
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.
Why Should You Attend:
Companies in the pharmaceutical and medical device space are required to implement statistically justified sampling plans for validation. This webinar will discuss methods for setting up sampling plans depending on the risk profile of the final product or production step. It will go into using the sampling plan to set statistically justified acceptance criteria for the validation. Also presented will be setting confidence levels and spreading that confidence level out over multiple runs. Setting statistically justified acceptance criteria for test method validation will also be discussed.
All companies in the pharmaceutical and medical device space are required to implement formal and statistically justified sampling plans and acceptance criteria for validation. Many companies do not have dedicated statistics departments, so it is up to the validation or quality engineer to develop sampling plans. This training will a simple step by step method of developing statistically justified sampling plans and acceptance criteria.
Areas Covered in the Session:
Why validate
What is Sampling
Validation Sampling
Setting up a Validation Sampling Plan
The concept of Acceptance Criteria
Use of Process Capability
Setting acceptance criteria for
Using acceptance sampling to set acceptance criteria