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.
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
Validation sampling
Setting up a validation sampling plan
Acceptance criteria
Using process capability
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
Validation sampling
Setting up a validation sampling plan
Acceptance criteria
Using process capability
from Medical Device and Pharmaceutical Companies
Alan M Golden
Alan M Golden has over 30 years of experience in the medical device industry, both in basic research and quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents, and published numerous papers and abstracts. Alan then transitioned to a quality assurance role wherein both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support, and operations.Alan’s quality assurance experience extends from design control, change control, risk …
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