BEDMINSTER, NJ — (Marketwired) — 06/12/13 — Elsevier Business Intelligence invites you to join your peers for a two-day, hands-on training workshop, , where you will learn how to implement a system that can withstand a rigorous FDA Inspection or ISO 13485 audit.
Two available dates and locations: June 25 & 26, Boston, MA | October 17 & 18, San Francisco, CA
During this interactive 2-day workshop, expert instructor, Dan O-Leary, Principal of Ombu Enterprises, will teach you the fundamentals of production and process controls. He will guide you through the fine points using the FDA-s own inspection documents coupled with extensive use of Warning Letters to illustrate the issues device manufacturer-s face.
Mr. O-Leary will begin by detailing the development of the Quality Management System (QMS), laying the regulatory foundation. He will then teach you how to set up your production system for the life cycle from design transfer to product release to Risk Management production information collection.
Over the course of two days, your instructor will address the following topics:
The role of design output and design transfer
Developing quality plans
Establishing, monitoring, and controlling process parameters
Production equipment including installation, maintenance, and effectiveness metrics
Validating production software
Controlling and calibrating measuring equipment including traceability
Evaluating and selecting external calibration laboratories
Production changes and when they are also design changes
Determining the process that require validation
Process validation as a statistical issue
Acceptance activities including sampling plans
Nonconforming product and associated corrective action
Risk management (ISO 14971) and production
the regular attendee rate. We have also introduced a special promotion and would like to extend the offer to you and your colleagues: If your company would like to take advantage of this opportunity, please at your convenience to register the third attendee once two registrations have been completed.
We hope to see you there!
MEDIA PARTNERS
Elsevier Business Intelligence, a global leader in the field of healthcare industry information, provides business intelligence on regulatory, business and reimbursement issues that are vital to the healthcare industry. Through a range of products including publications, conferences, e-learning, databases and reports, Elsevier Business Intelligence places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge, by providing the perfect combination of news and information together with penetrating insight and analysis. Our leading publications include PharmAsia News, IN VIVO and “The Pink Sheet.” For more information, visit: .
Elsevier is a world-leading provider of scientific, technical and medical information products and services. The company works in partnership with the global science and health communities to publish more than 2,000 journals, including and , and close to 20,000 book titles, including major reference works from Mosby and Saunders. Elsevier-s online solutions include , , , and , which enhance the productivity of science and health professionals, and the and , which help research and health care institutions deliver better outcomes more cost-effectively.
A global business headquartered in Amsterdam, employs 7,000 people worldwide. The company is part of , a world-leading publisher and information provider, which is jointly owned by Reed Elsevier PLC and Reed Elsevier NV. The ticker symbols are REN (Euronext Amsterdam), REL (London Stock Exchange), RUK and ENL (New York Stock Exchange).
Kristen Macholtz
Elsevier Business Intelligence
908-748-1192