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

Quality Management Systems that Comply with ISO13485:2016

Course Description:

The Course "Quality Management Systems that Comply with ISO13485:2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

ISO 13485:2016 indicates prerequisites for a quality administration framework where an association needs to exhibit its capacity to give medical devices and related administrations that reliably meet client and relevant administrative necessities. Such associations can be included in at least one phase of the life-cycle, including plan and advancement, creation, stockpiling and circulation, establishment, or overhauling of a restorative device and outline and improvement or arrangement of related exercises (e.g. specialized support).

Prerequisites of ISO 13485:2016 are relevant to associations paying little heed to their size and paying little mind to their sort with the exception of where expressly expressed. Wherever prerequisites are indicated as applying to restorative devices, the necessities apply similarly to related administrations as provided by the association. 

The procedures required by ISO 13485:2016 that are pertinent to the association, yet are not performed by the association, are the obligation of the association and are represented in the association's quality administration framework by checking, keeping up and controlling the procedures. 

On the off chance that appropriate administrative necessities allow prohibitions of plan and improvement controls, this can be utilized as a defense for their avoidance from the quality administration framework. These administrative prerequisites can give elective methodologies that are to be tended to in the quality administration framework. It is the obligation of the association to guarantee that cases of adjustment to ISO 13485:2016 mirror any rejection of plan and improvement controls.

For a long time, ahead of schedule in the life of ISO 9001 and ISO 13485, it took a ton of instruction with respect to ISO examiners to show organizations the contrast between Corrections (settling the issue) and Corrective Actions, fixing the underlying driver of the issue. Organizations have now taken in these definitions truly well. In any case, the Corrective Action and Preventive Action (CAPA) framework frequently do not cover rectification and control activities identified with CAPAs. Adjustments for item issues are generally being done under different bits of ISO 13485, for example, control of nonconforming item and client criticism and grievances. These regularly have the little visibility in the Corrective Action framework, and by and large, don't address at all containing or rectifying quality framework issues that are frequently a noteworthy part of a CAPA framework. So now ISO evaluators, or if nothing else ISO 13485 Notified Body reviewers, are expecting that organizations record and give prove that they are doing regulation as well as rectifications, totally and rapidly. 

Join Lena Cordie  in this interactive workshop to get detailed guidance on how to develop, implement and maintain strategies in order to achieve a specific goal. This session will include lectures, round table discussions and activities all aimed at understanding key strategies and identifying specific actions to effectively improve Quality Management System Compliance.