AS 326-3 ISO 13485 INTERNAL AUDITOR - MEDICAL DEVICES

DO NOT PAY BY PAYPAL.  WITHHOLD PAYMENT UNTIL CLASS IS CONFIRMED.

This course meets 2 days starting Tuesday, February 16th and ends Wednesday, February 17, 2010

AS 326  ISO 13485 INTERNAL AUDITOR COURSE

Instructor: Wayne Paupst,  CSSBB, CQE, CMQ/OE, CQA, CQI, CQPA, CQIA

Abstract:

This course covers the fundamentals of Internal Auditing of an ISO 13485 Quality Management System. An element by element review of the ISO 13485 Standard and Auditing Planning, Performing, and Reporting, along with Corrective Action and Follow up will be covered.

Course Topics and Organization:

The following topics representing will be covered in the classroom.

·         Quality Concepts

·         Quality Tools

·         Inspection & Sampling

·         Metrology & Calibration

·         Blueprint Reading

·         Quality Audits

·         Corrective/Preventive Actions

·         Basic Statistics

·         Control Charts

Classroom Approach to the Class

This is an adult centered course for busy professionals.  The class is intended to provide:

 o        Enough review during the class such that only nominal additional preparation is required. 

o        Practice Exercises will be utilized during the course to allow participants to replicate potential real time audit scenarios. 

o        In addition, the course provides a forum for discussion of and advice with respect to the students’ individual professional circumstances, and the instructor’s experiences.

 Course Text – A course workbook along with a copy of the ISO 13485 Requirements are included.

A continental breakfast, morning and afternoon breaks and lunch are included in the tuition.

1.  A 10 % discount will be applied to the purchase of 3 or more registrations either on-line or with a company purchase order.

2.   This course will be held if there are at least six registered and paid attendees.

3.  Also available as an ON-SITE Course.

4.  Do not pay the course fee until you are notified by the instructor that the course will be offered.

Payment for the course is due by the first class session unless prior arrangements are made with the Registrar.

For Payment by Check

Make payable to: ASQ Philadelphia Section 505

Mail remittance to:

ASQ Philadelphia Education Registrar

149 Kirkland Ave

West Chester PA 19380-3982

For Invoicing:

Send Company Purchase Order made to: ASQ Philadelphia Section 505

Provide: Contact name, mailing address, telephone number of the person to receive the invoice.

Send to

ASQ Philadelphia Education Registrar

149 Kirkland Ave.

West Chester  PA  10380-3982

Questions: Email: captkmcc@verizon.net

Phone: 610-696-7589

Tuesday, February 16, 2010 at 8:30 AM
- to -
Wednesday, February 17, 2010 at 4:30 PM (ET)

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Pennsylvania State University (PSU) Great Valley Campus
30 E. Swedesford Road
Malvern, PA 19355

Philadelphia Section -American Society for Quality

The Philadelphia Section of the American Society for Quality (ASQ) is one of the leading sections in the nation, with 1200+ members! Come join us for this exciting course.

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