Statistical Justification for Sample Size & Use of Only 3 Lots: ASQ NCDG Ro...

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Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

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Back to BasicsStatistics/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 calculations is worked through completely, from pre-control R&D lots through to the correct wording for Process Validation Report conclusion statements.

FEATURED SPEAKER:

John N. Zorich, MS, CQE, worked 20 years as a "regular" employee in manufacturing, R&D, QA/QC, and Regulatory, primarily in medical device and biologics companies. In 1999, he became an independent consultant and trainer in quality systems and applied statistics. From 2000-2014, he worked half-time as an ISO/MDD auditor for European Notified Bodies TUV, KEMA/DEKRA. He's given several 2-day courses in applied statistics for Silicon Valley ASQ Biomedical; and annually since 2005, he's taught a 3-day Applied Statistics seminar for Ohlone College (this year June 11-13). Since 1999, he's given more than 200 statistics webinars & seminars, e.g. for the 2014 ASQ World Conference on Quality, UC Santa Cruz Extension, numerous SV startups, and recently for San Jose State's Dept. of Biomedical Engineering. His statistical consulting clients have included more than 150 mostly small companies, but also Boston Scientific, Siemens, and Novellus. Since 2014, he's been DEKRA's in-house consultant on statistics related to Design Dossiers and Technical Files. He's written several commercial statistical application software programs that have been purchased by more than 110 companies worldwide. He continues to work as a statistics consultant and trainer for clients throughout the US. This will be John’s fourth NCDG presentation.

Moderator: Barry Craner, former VP QA.RA, Stellartech Research Corp, Past Chair ASQ Biomedical Division, Past Chair ASQ San Diego Section, FASQ, CQE, CRE, CQA, CBA.

Location: Stellartech Research Corporation, 560 Cottonwood Dr, Milpitas, CA 95035

Food: Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.

Email: To be added to or removed from our email list, contact George Marcel, gjmarcel@gmail.com.

Registration Link: http://ncdgjun2019.eventbrite.com/

ONLY Check or Credit Card accepted at door

Questions: For information about this session, contact: John Zorich, at johnzorich@yahoo.com


Formal discussion and questions will end between 8:30 - 8:40 pm to allow time for networking.

Materials: Presentation & workshop sheets provided for onsite attendees only. Please limit distribution to attendees: personal professional use only.

Webinar Remote Access (no cost):

https://attendee.gotowebinar.com/rt/8290285084177151234







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Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

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