Workshop on Statistical Techniques for Medical Device Manufacturers
Two days workshop on
Statistical Techniques for Medical Device Manufacturers
Coming soon.. Please contact customer care for new schedule at +1-510-857-5896
Course Description
The FDA's Quality System Regulation (QSR) requires device manufacturers to identify valid statistical techniques to "establish, control, and verify the acceptability of process capability and product characteristics". When device manufacturers analyze CA & PA information, they must also use "appropriate statistical methodology". In addition, sampling plans must be valid, documented, adequate, and reviewed based on changes.

Some manufacturers are not clear about all of this. Others are nervous about creating a sufficient approach to make good decisions and satisfy the regulations. The result may be a patchwork of techniques without a coherent methodology. This workshop helps resolve the problem.

Learning Objectives
The workshop starts with an understanding of the regulations including QSR, ISO 13485:2003, and ISO 13485:2016. It also includes the methods regulators use to check compliance including the Quality System Inspection Technique (QSIT), FDA Warning Letters, and the Medical Device Single Audit Program (MDSAP).

The FDA regulations don't provide a catalog of available techniques or their application. This is the role of ISO/TR 10017:2003Guidance on statistical techniques for ISO 9001:2000. While this guidance was written for ISO 9001:2000, it is easily applicable to FDA QSR, ISO 13485:2003, and ISO 13485:2016.

The guidance document provides a list of statistical techniques and explains how each applies to particular ISO 9001:2003 clauses. Mapping these applications to FDA QSR, ISO 13485:2003, and ISO 13485:2016 is straightforward and provides a robust approach to help a manufacturer identify the appropriate methods.

The workshop explains the many of the techniques, shows how they apply using medical device examples, and includes exercises for participants to solidify understanding.

Why Should you Attend
Statistical techniques are powerful methods for medical device manufactures since they can help improve efficiency and effectiveness. Many techniques apply in a variety of situations. This workshop explains how to evaluate the situation, determine the correct technique and apply it. In addition, since there are regulatory requirements, the workshop includes the necessary documentation to satisfy audits and inspections.

Who will Benefit
  • All medical device manufacturers that apply FDA QSR, ISO 13485:2003 or ISO 13485:2016
  • Quality Managers
  • Quality Engineers
  • Quality Assurance and Quality Control
  • Regulatory Affairs Managers
  • Regulatory Affairs Professionals
  • R&D Managers
  • R&D Engineers
  • Product Design and Development
  • Operations Managers
  • Production Managers and Supervisors
  • Manufacturing Engineers
  • Risk Managers
  • Complaint system team members
  • CA&PA team members

Day One (8:00 a.m. - 8:30 a.m.: Registration Process)

Part A - Statistical Techniques in the Regulations
  • ISO 13485:2003
  • ISO 13485:2016
  • The Quality System Inspection Technique, QSIT
  • The Medical Device Single Audit Program, MDSAP
  • FDA Warning Letters
Part B - Identifying Statistical Techniques
  • The Problem and a Solution
  • Using ISO/TR 10017:2003
  • Using GHTF/SG3/N18:2010
Part C - Descriptive Statistics
  • Data Types
  • Measurement Scales
  • Common Descriptive Statistics
  • Graphical Methods
  • Statistical Distributions
  • Some Common Distributions
Part D - Hypothesis Tests
  • The Concepts
  • Comparing a Mean to a Standard
  • Comparing Two Means
  • Paired t-Test
  • Other Applications
Part E - Regression Analysis
  • The Concepts
  • Linear and Non-linear Methods
  • Using Excel
  • Residuals
Day Two

Part F1 - Attribute Sampling Plans
  • Sampling Plan Concepts
  • ANSI/ASQ Z1.4
  • Single Sampling Plans
  • Double and Multiple Sampling Plans
  • c=0 Sampling Plans
Part F2 - Variables Sampling Using Z1.9
  • Normality Assumptions
  • Acceptance Sampling Concepts
  • ANSI/ASQ Z1.9 Methods
  • Comparative Sample Size
Part G1 - SPC Variables Charts
  • x-bar and R Charts
  • x-bar and s Charts
  • I and MR Charts
  • OC and ARL Curves
  • Calculating Control Lines
  • Interpreting the Results
Part G2 - SPC Attributes Charts
  • p Charts
  • np Charts
  • u Charts
  • c Charts
  • OC and ARL Curves
  • Calculating Control Lines
  • Interpreting the Results
Part H - Process Capability Analysis
  • Cp and Pp
  • Cpk and Ppk
  • Interpreting the Results
Part I - Measurement System Analysis (MSA)
  • Measurement Analysis
  • The Components of Variability
  • Applications to Metrology

Daniel O'Leary - President, Ombu Enterprises, LLC

Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.