Conference 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." Some manufacturers are not clear about what this means, while others employ statistical techniques but remain nervous about this means.

Similarly, sampling plans must be valid, documented, adequate, and reviewed based on changes.

In addition, statistical methodology, as part of CA & PA, is required to identity recurring quality problems based on data system analysis. A similar requirement applies to servicing analysis.

In addition, the requirement for process validation with a "high degree of assurance" is a requirement for process capability and product characteristics, i.e., a statistical technique.

These four areas often create a patchwork of techniques without a coherent approach. This seminar will help you resolve the problem.

The seminar starts with an understanding of the regulations through a variety of sources. Each application of statistical techniques starts with the regulatory requirements and is augmented by the preamble, where FDA addressed the comments it received on the proposed QSR. FDA published an extensive manual to help manufacturers implement the regulations. The seminar analyzes the objectives in the Quality System Inspection Technique (QSIT) and then turns to Warning Letters to help understand the issues.
Learning Objective:
Learn the sections of FDA QSR that require statistical techniques.
Understand how to apply the FDA tools to develop a clear understanding of the requirements.
Regulation
Preamble
Small Entity Compliance Guide
QSIT
Warning Letters
Understand the set of statistical techniques in ISO/TR 10017
Learn how to implement and apply the ISO/TR 10017 statistical techniques.
Who will Benefit:
All medical device manufacturers that apply FDA QSR or ISO 13485:2003:

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
CAPA team members