Production and Process Control: Building a Robust System

Production Process Control

Two days workshop on:

Date:           31 August 2017 & 01 September 2017

Location:    Boston, MA

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.

Areas Covered

Over the course of two days, 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 & effectiveness metrics

•          Validating production software

•          Controlling and calibrating measuring equipment including trace-ability

•          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 yourself for this brainstorming session now and get special group discounts on registration- Production and Process Control: Building a Robust System