How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing

GlobalCompliancePanel

Course

In Houston (USA)

£ 1,031.43 VAT inc.

*Indicative price

Original amount in USD:

$ 1,295

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Description

  • Type

    Seminar

  • Location

    Houston (USA)

  • Class hours

    9h

  • Duration

    2 Days

Design Control processes (verification, validation

The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

ISO standards and FDA/MDD regulations regarding the use of statistics.
Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
Statistical Process Control
Statistical methods for Design Verification
Statistical methods for Product/Process Qualification
Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications
How to craft "statistically valid conclusion statements" (e.g., for reports)
Summary recommendations

Facilities

Location

Start date

Houston (USA)
See map
15747 JFK Blvd, TX 77032

Start date

On request

About this course


FDA, ISO 9001/13485, and MDD requirements related to statistical methods
How to apply statistical methods to manage product-related risks to patient, doctor, and the designing/manufacturing company
Design Control processes (verification, validation, risk management, design input)
QA/QC processes (sampling plans, monitoring of validated processes, setting of QC specifications, evaluation of measurement equipment)
Manufacturing processes (process validation, equipment qualification)


QA/QC Supervisor
Process Engineer
Manufacturing Engineer
QC/QC Technician
Manufacturing Technician
R&D Engineer

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Reviews

Subjects

  • Metrology
  • Confidence Training
  • Statistics
  • Design
  • Process Control
  • Healthcare
  • Medical training
  • Pharma
  • Regulatory
  • Compliance

Teachers and trainers (1)

John N. Zorich John N. Zorich

John N. Zorich John N. Zorich

Statistical Consultant & Trainer, Ohlone College & SV Polytechnic

John N. Zorich, has spent 35 years in the medical device manufacturing industry; the first 20 years were as a "regular" employee in the areas of R&D, Manufacturing, QA/QC, and Regulatory; the last 15 years were as consultant in the areas of QA/QC and Statistics. His consulting clients in the area of statistics have included numerous start-ups as well as large corporations such as Boston Scientific, Novellus, and Siemens Medical. His experience as an instructor in statistics includes having given 3-day workshop/seminars for the past several years at Ohlone College (San Jose CA), 1-day training

Course programme

Day 1 Schedule Lecture 1:

Regulatory Requirements

Lecture 2:

Vocabulary and Concepts

Lecture 3:

Confidence Intervals (attribute and variables data)

Lecture 4:

Normality Tests and Normality Transformations

Lecture 5:

Statistical Process Control (with focus on XbarR charts)

Lecture 6:

Confidence/Reliability calculations for Proportions

Lecture 7:

Confidence/Reliability calculations for Normally distributed data (K-tables)

Lecture 8:

Process Capability Indices calculations(Cp, Cpk, Pp, Ppk)

Day 2 Schedule Lecture 1:

Confidence/Reliability calculations using Reliability Plotting (e.g., for non-normal data and/or censored studies)

Lecture 2:

Confidence/Reliability calculations for MTTF and MTBF (this typically applies only to electronic equipment)

Lecture 3:

Statistical Significance: t-Tests and related "power" estimations

Lecture 4:

Metrology (Gage R&R, Correlation, Linearity, Bias , and Uncertainty Budgets)

Lecture 5:

QC Sampling Plans (C=0 and Z1.4 attribute AQL plans, and alternatives to such plans), including OC curves, AQL vs. LQL/LTPD, AOQL, and calculation of acceptance rates.

Lecture 6:

Statistically valid statements for use in reports

Lecture 7:

Summary and Implementation Recommendations

See related categories

How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing

£ 1,031.43 VAT inc.

*Indicative price

Original amount in USD:

$ 1,295

The best Medicine courses

See all

See all