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.

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 provides a comprehensive overview of process validation principles and practices specific to the medical device industry.