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  • Acceptance Sampling - The Total Picture: 2-day In-person

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Jun 05, 2014 08:30 AM
  • End Time:
  • Friday - Jun 06, 2014 04:30 PM
  • Location:
  • San Diego,
    California, United States
  • Course Description:
    How well do you understand sampling plans and their application in your company? Many companies have procedures and program that fall short of the regulatory requirements and good statistical practice. In some cases, FDA may give the firm a 483 or even a Warning Letter. In other cases, the firm may not use the best methods, resulting in waste of resources.

    This unique hands-on course will provide attendees with a solid understanding of acceptance sampling methods and their application to medical device manufacturing. The course delivers tools, templates, and insight that will allow participants to implement sampling methods within their firm.

    This two-day hands-on course provides a clear understanding of the underlying statistics used in acceptance sampling. The course uses exercises to solidify understanding. As part of the practical implementation, the course explains common standards such as Z1.4 for attribute sampling and Z1.9 for variables sampling. In addition, the course covers other, less well known, methods such as sequential sampling, continuous sampling, and chain sampling.

    The course also covers specific applications of sampling including incoming inspection, design validation, design verification, process validation, and quality audits.

    Learning Objective:
    Upon course completion, participants will:

    -Understand FDA QSR and ISO 13485 requirements for acceptance sampling
    -Perform calculations using the binomial distribution
    -Perform calculations using the hypergeometric distribution
    -Perform calculation using the normal distribution
    -Apply tests of normality to a data set
    -Understand Acceptable Quality Limit (AQL) and apply it
    -Understand Operating Characteristic (OC) curves
    -Select sampling plans from Z1.4
    -Select sampling plans from Z1.9
    -Implement sequential sampling plans (using the Wald method)
    -Implement continuous sampling plans (CSP)
    -Implement skip-lot sampling plans (SkSP)
    -Implement chain sampling plans (ChSP)

    Who will Benefit:
    -Quality Managers
    -Quality Engineers
    -Supplier Quality Engineers
    -Quality Analysts
    -Production and Process Engineers
    -Design and Development Engineers
    -Verification and Validation Specialists
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