Back to Basics –Statistics/Process Validation:

Statistical Justification for Sample Size & Use of Only 3 Lots

How can we be ensured such a critical product assessment is so simple, yet appropriate?

Wednesday, June 12, 2019, 7:00 to 9:00 pm

Topic: Statistics/Process Validation

§820.75 Process Validation. (a) Where the results of a process cannot be fully verified by subsequent inspection & test, the process shall be validated with a high degree of assurance & approved according to established procedures.

ABSTRACT:

This seminar provides a statistical justification for: (1) sample sizes of lots used in verification/validation studies, and (2) the use of only 3 such lots when performing process validation. The goal of the seminar is to help the attendee avoid: (1) delays in product regulatory approvals, and (2) nonconformities from quality-system audits. This seminar does not address clinical trials nor bulk-solution processes; it applies to medical devices and components and unitized products such as pills, drug-filled syringes. One set of example