Please check the entry requirements here before booking

This 5 day programme is designed to provide a detailed understanding of the process of validation for regulated industries, with particular focus on validation for the manufacture of medical devices and the requirements of ISO EN 13485 and FDA QSR. The course aims to explore in some depth:

• All validation activities;
• The reasons for these activities and how best to meet these requirements and methodologies.

All of these topics will be expanded on and case studies/examples will be included in order to best communicate the method for validation.

Introduction

A two-day course which covers the specification and selection of the equipment necessary for the entire moulding process. Starting from the machine and working outwards to cover all the key aspects of the process.

On successful completion, trainees will know the key points to be able to specify a range of capital equipment and to identify and troubleshoot a range of issues caused by incorrect specification of equipment. They should be able to consider aspects critical not only to part quality but also to productivity, capital cost and environmental impact.

Please check the entry requirements here before booking 

Operation Clean Sweep® (OCS) is an EU approved international programme aimed at improving awareness, promoting best practices and providing guidance and tools to support companies from the plastic and polymers value chain in the implementation of the necessary pellet loss prevention measures.

The initiative’s aim is to ensure that the plastic pellets, flakes and powders that pass through manufacturing facilities in Ireland are handled with the care they deserve and do not end up in our rivers or seas.

By signing up to OCS, companies make a commitment to adhere to best practice and implement systems to prevent plastic pellet loss — and that they will play their part in protecting the aquatic environment.

Led by Polymer Technology Ireland, this webinar will give participants an overview of the requirements of OCS and a practical guide to implementing the necessary steps to become a signatory of the initiative.

For more on OCS, visit https://www.opcleansweep.eu/. 

This course Please check the entry requirements here before booking 

This course is designed for Senior Management, Product Design Managers, Process Engineers, Manufacturing Cell Business Owners, Production Team Leaders QA and Regulatory personnel working on projects in industry.

Learners will have a complete understanding of:

• The Project Lifecycle

• Project Documentation

• Project Management Standards

Learners will be introduced to:

• Project Management Tools

• Microsoft Project

Please check the entry requirements here before booking

Programme overview

This 2 day programme is designed to provide detailed understanding of cleaning validation for regulated industries, with particular focus on medical device and pharmaceutical cleaning activities.

Please check the entry requirements here before booking

Programme Overview: 

Computer system validation is a critical tool to assure quality of computer system performance. CSV enhances the reliability of system, resulting in fewer errors and less risk to process the date integrity. A primary goal of software validation is to demonstrate that all completed software products comply with all documented software and system requirements. Confirmation is an important part of the overall design validation to ensure that all aspects of the medical device confirm to user needs and intended uses.