Validation sampling plans need to be statistically justified, and the acceptance criteria that go with them have to stand up too. This 60-minute validation sampling plans webinar shows how to set both up for process validation.
You'll learn how validation sampling differs from lot acceptance sampling, what to decide before sampling, and the steps for building a plan based on the risk profile of the final product or production step. The session compares variables and attributes sampling plans and covers how to set confidence levels and spread them over multiple runs.
It then explains variance, process capability (Cp vs Cpk) and how to use them to set acceptance criteria, including for test method validation.
WHY SHOULD YOU ATTEND?
Pharmaceutical and medical device companies must have formal, statistically justified sampling plans and acceptance criteria for validation. Many have no dedicated statistics department, so the work falls to validation or quality engineers. This training offers a simple, step-by-step method.
It suits QA professionals, technical scientists, production staff and statisticians involved in validation at medical device and pharmaceutical companies.
AREA COVERED
What is sampling
- Making a quality judgment about many items without examining each one
Validation sampling
- How it differs from lot acceptance sampling
Setting up a validation sampling plan
- Pre-sampling determinations
- Steps to set up a sampling plan
- Variables vs attributes sampling plans
Acceptance criteria
- The concept of acceptance criteria
- Variance: how much is too much
- How and why to measure variance
Using process capability
- The concept of process capability
- Cp vs Cpk
- Using process capability to set acceptance criteria
LEARNING OBJECTIVES
- Explain how validation sampling differs from lot acceptance sampling
- Set up a statistically justified sampling plan based on risk
- Choose between variables and attributes sampling plans
- Set confidence levels and spread them across multiple runs
- Measure variance and use Cp and Cpk to set acceptance criteria
- Set statistically justified acceptance criteria for test method validation
WHO WILL BENEFIT?
- QA professionals
- Technical scientists
- Production staff
- Statisticians involved in validation
from Medical Device and Pharmaceutical Companies
Pharmaceutical and medical device companies must have formal, statistically justified sampling plans and acceptance criteria for validation. Many have no dedicated statistics department, so the work falls to validation or quality engineers. This training offers a simple, step-by-step method.
It suits QA professionals, technical scientists, production staff and statisticians involved in validation at medical device and pharmaceutical companies.
What is sampling
- Making a quality judgment about many items without examining each one
Validation sampling
- How it differs from lot acceptance sampling
Setting up a validation sampling plan
- Pre-sampling determinations
- Steps to set up a sampling plan
- Variables vs attributes sampling plans
Acceptance criteria
- The concept of acceptance criteria
- Variance: how much is too much
- How and why to measure variance
Using process capability
- The concept of process capability
- Cp vs Cpk
- Using process capability to set acceptance criteria
- Explain how validation sampling differs from lot acceptance sampling
- Set up a statistically justified sampling plan based on risk
- Choose between variables and attributes sampling plans
- Set confidence levels and spread them across multiple runs
- Measure variance and use Cp and Cpk to set acceptance criteria
- Set statistically justified acceptance criteria for test method validation
- QA professionals
- Technical scientists
- Production staff
- Statisticians involved in validation
from Medical Device and Pharmaceutical Companies