The Process and Logistics of Internal Quality Auditing in a Regulatory Environment
Quality auditing is a tool used to measure the effectiveness of a Quality Management System. Having a working understanding of the nuances of process architecture and how sub-systems interact is key to a medical device manufacturer’s regulatory compliance and business success.
This webinar CD addresses quality auditing in the medical device industry. Based on the following regulation and industry standard, it examines the requirements, techniques, objective evidence, and logistics involved in internal quality auditing that supports your company’s Quality Management System:
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ANSI/AAMI/ISO 13485:2003, Medical Devices — Quality Management Systems, Requirements for Regulatory Purposes
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21 CFR, Part 820, Good Manufacturing Practices — Quality System Regulation
PROGRAM OBJECTIVES
The webinar CD provides an introduction to the process of auditing. The program discusses the importance of clear communication, relationship building and the over-arching requirements for documentation and objective evidence in a regulated environment. Using the standard and regulation as a foundation, attendees will learn how to effectively use certain investigative methods to understand levels of compliance and opportunities for improvement.
You will hear from experienced auditing professionals who share their past experiences, provide suggestions and techniques, and demonstrate how auditing can be used to improve a Quality Management System. Please note this is not a certification program.
PROGRAM-AT-A-GLANCE
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Overview of Auditing: The Regulated Years | |
| Product | Process | |
| System | Management | |
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Conducting Audits: ANSI/AAMI/SO 13485:2003 and the Quality System Regulation | |
| Scope and similarities | Terms and definitions | |
| Linkages with other processes within the Quality Management System (QMS) | Compliance expectations for objective evidence and effectiveness | |
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The Process of Auditing | |
Foundation and Infrastructure |
Logistics and Guidance - Audit preparation and due diligence - Making contact - The opening meeting - Audit techniques - Conducting the audit - Personalities, push-back, and politics - The audit trail - The closing meeting |
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The Post-Audit Phase | |
| Reporting the Audit | Compliance and improvement | |
| Corrective and preventive actions | Verification and / or validation of effectiveness | |
| Audit closeout | ||
SPEAKERS
| John Gagliardi, President, MidWest Process Innovation, LLC | |
| Maggie Purcell, Supplier Quality Auditing Unit Manager, Cordis Corporation |
WEBINAR CD
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includes handout material and CD |
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$295 for webinar registrants | $395 for non-registrants |
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Please note domestic and international shipping rates apply |
THREE WAYS
TO PURCHASE
1.
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Phone - 1-877-249-8226/ 240-646-7031 to order with a credit card. |
2.
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Fax - Select and download the order form and fax to 301-206-9789. |
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Mail - Select and download the order form and mail with payment to: Auditing Webinar CD Package |
QUESTIONS
For questions about ordering the CD, please contact Publications at 1-877-249-8226/ 240-646-7031, ext. 217, or 1-800-332-2264, ext. 217. For questions about CD content, contact Virginia Schoenauer at 703-525-4890, ext. 247.