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

Statistical Techniques for Medical Device Manufacturers

Statistical Techniques for Medical Device Manufacturers

By - Dan O'Leary, President at Ombu Enterprises, LLC on 30 November 2017 & 01 December 2017

Location: San Francisco, CA  

The seminar starts with an understanding of the regulations through a variety of sources. Ex: QSR, ISO 13485:2003, and ISO 13485:2016. Each application of statistical techniques starts with the regulatory requirements and is augmented by the preamble, where FDA addressed the comments it received on the proposed QSR. FDA published an extensive manual to help manufacturers implement the regulations. The seminar analyzes the objectives in the Quality System Inspection Technique (QSIT), the Medical Device Single Audit Program (MDSAP) and then turns to Warning Letters to help understand the methods of regulators.

In addition to statistical methodology, as part of CA & PA information, is required to identity recurring quality problems based on device manufacturers analysis. A similar requirement applies to servicing analysis. The requirement for process validation with a "high degree of assurance" is a requirement for process capability and product characteristics, i.e., a statistical technique.

Upon course completion participants will be able to:

•         Learn the sections of FDA QSR that require statistical techniques.

•         Understand how to apply the FDA tools to develop a clear understanding of the requirements.

·*     Regulation

·*     Preamble

·*     Small Entity Compliance Guide

·*     QSIT

·*     Warning Letters

•       Understand the set of statistical techniques in ISO/TR 10017

•        Learn how to implement and apply the ISO/TR 10017 statistical techniques.

Register yourself for this brainstorming session Now- Statistical Techniques for Medical DeviceManufacturers