Introduction to Statistical Methods and Tools for a Quality System
Having a solid understanding of statistical methods and tools used to support your organization’s Design Control and Process Validation activities is important for regulatory compliance and business success. To address the industry’s need for further education on how to use statistical methods and tools to satisfy the requirements of the Food and Drug Administration’s (FDA) Quality System regulation, AAMI developed this webinar on CD — Statistical Methods and Tools for a Quality System.
This two-hour program is an introduction to statistical methods and tools and covers the following:
- Examines the importance of applying statistical tools to your Quality System
- Reviews where statistical tools can be used in Design Control and Process Validation
- Summarizes the recommendations of guidance documents developed by FDA and the Global Harmonization Task Force (GHTF)
- Offers industry best practices on the tools considered to be the most important by industry professionals
- Provides a forum where you can ask questions and get answers.
Don’t miss out on this exciting educational opportunity to learn more about the value of applying statistics to your Quality System!
PROGRAM-AT-A-GLANCE
- Regulatory Context
- Quality System Regulation 21 CFR 820
- ISO Guidance for Quality Management Systems
- FDA Guidance for Design Control
- GHTF Guidance for Process Validation
- Industry Needs and Best Practices
- Value Added to a Product or Process
- Mapping of Methods and Tools to Requirements of:
- Design Control
- Process Validation - Top Methods and Tools Identified in Industry Survey
- Demonstration of Best Practices
- Measurement System Analysis (aka, Gage R&R)
- Sampling Plans
- Capability Analysis
- Design of Experiments
- Q&A on General Topics
SPEAKER
- Peter Knepell, PhD, President, Peak Quality Services
AAMI Faculty Member for Process Validation course and soon-to-be launched Statistical Tools and Methods Workshop
WEBINAR CD - Includes pdf of handout materials and webinar recording on CD.
- $295 for webinar registrants
- $395 for non-registrants
- Please note: Domestic and international shipping rates apply.
THREE WAYS TO ORDER
- Phone - 1-800-373-3174 to order with a credit card
- Fax - Select and download the order form and fax to 240-396-5781
- Mail - Select and download the order form and mail with payment to:
Statistics Webinar CD
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For
questions about ordering the CD, please contact Publications at 1-877-249-8226 or 240-646-7031.