BEDMINSTER, NJ -- (Marketwired) -- 06/12/13 -- Elsevier Business Intelligence invites you to join your peers for a two-day, hands-on training workshop, Production and Process Controls: Building a Robust Approach, 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
Register today and save $300 off the regular attendee rate. We have also introduced a special promotion and would like to extend the offer to you and your colleagues: Any company with two registered delegates will receive a complimentary ticket for a third delegate. If your company would like to take advantage of this opportunity, please contact us at your convenience to register the third attendee once two registrations have been completed.
We hope to see you there!
Most Popular Stories
- 15 Myths That Could Ruin Your Hispanic Ad Campaign
- AIG to Create 230 Jobs in Charlotte
- General Motors Names Mary Barra as First Female CEO
- Russia Says Nyet to Canada North Pole Claim
- Bipartisan Negotiators Reach Modest Budget Agreement
- Senate Dems Move Forward With Obama Nominees
- Justin Bieber Visits Typhoon Victims, Plays Concert
- New Obama Aide to Focus on Climate Change
- Obama Nominee Confirmed for D.C. Appeals Court
- MasterCard to Split Shares, Raise Dividend