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

2-Day Training Workshop | Production and Process Controls: Building a Robust 
Approach 
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! 
MEDIA PARTNERS 
http://www.massmedangels.com/ 
http://www.fiercemedicaldevices.com/ 
http://www.marketwired.com/ 
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: http://www.ElsevierBi.com. 
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). 
Media contact:
Kristen Macholtz 
Elsevier Business Intelligence
908-748-1192 
k.macholtz@elsevier.com