Statistical Techniques for Medical Device Manufacturers at Philadelphia, PA

Overview:

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". Some manufacturers are not clear about all of this. Others are nervous that their approach is sufficient.

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

These issues can create a patchwork of techniques without a coherent methodology. This seminar helps resolve the problem.

Why you should attend:

The seminar starts with an understanding of the regulations through a variety of sources. This includes the Quality System Inspection Technique (QSIT) as well as Warning Letters.

The FDA regulations don't provide the available techniques or their application. This is the role of ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000. While this guidance applies to an earlier version of ISO 9001, both FDA QSR and ISO 13485 are ISO 9001 successors.

The guidance document provides a list of statistical techniques and explains how each applies to the particular ISO 9001 clauses. Mapping these applications to FDA QSR is straightforward and provides a robust approach to help a manufacturer identify and implement the appropriate methods. The seminar provides the cross reference to help you decide on which techniques to apply.

The seminar explains the methods, shows how they apply using medical device examples, and includes exercises for participants to solidify understanding.

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

·         CA&PA; team members

Agenda:

Day One

Lecture 1: Statistical Techniques in FDA QSR

·         QSIT

·         Warning Letters

Lecture 2: Applications of ISO/TR 10017:2003

Lecture 3: Descriptive Statistics

Lecture 4: Hypothesis Testing

Lecture 5: Regression Analysis

Day Two:

Lecture 6: Acceptance Sampling Plans (Attributes and Variables)

Lecture 7: Statistical Process Control (Attributes and Variables)

Lecture 8: Process Capability Analysis

Lecture 9: Measurement Analysis

Speaker:

Dan O'Leary 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.

Location: Philadelphia, PA        Date: July 30 & 31, 2015        Time: 9:00 AM to 6:00 PM EDT 
Venue: DoubleTree by Hilton Hotel Philadelphia Center City

Venue Address:  237 South Broad Street, Philadelphia, Pennsylvania, 19107-5686, USA

Price: $1,295.00   (Seminar for One Delegate)

Register now and save $200. (Early Bird)

Until April 30, Early Bird Price: $1,295.00   

From May 01 to July 28, Regular Price: $1,495.00

Contact Information:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA         

USA Phone: 800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com          

http://www.globalcompliancepanel.com

Event Registration Link - http://bit.ly/1zzZDvv