SOURCE: Elsevier Business Intelligence

June 12, 2013 12:02 ET

2-Day Training Workshop | Production and Process Controls: Building a Robust Approach

BEDMINSTER, NJ--(Marketwired - Jun 12, 2013) - 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!


About Elsevier Business Intelligence
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:

About Elsevier
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 The Lancet and Cell, and close to 20,000 book titles, including major reference works from Mosby and Saunders. Elsevier's online solutions include SciVerse ScienceDirect, SciVerse Scopus, Reaxys, MD Consult and Mosby's Nursing Suite, which enhance the productivity of science and health professionals, and the SciVal suite and MEDai's Pinpoint Review, which help research and health care institutions deliver better outcomes more cost-effectively.

A global business headquartered in Amsterdam, Elsevier employs 7,000 people worldwide. The company is part of Reed Elsevier Group PLC, 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).

Contact Information

  • Media contact:
    Kristen Macholtz
    Elsevier Business Intelligence
    Email Contact