Introduction to Microbiology for the Manufacture of Sterile Medical Devices / Products

Introduction

This course is intended to cover the fundamentals of microbiology as it applies to the medical devices, pharmaceutical and associated industries in a real world context to ensure that your product meets the requirements of the patient and of you, the manufacturer.

For products that need to be supplied sterile, products are sterilized by one or more technologies, Sterilization is a special process which requires validation and routine control to ensure that the product meets the requirements.

For products that need to be supplied clean, microbiological control of the processes can be just as important to the patient and you, the manufacturer.

Benefits of attending

Provide you with the knowledge and tools to:-

• Solve those real life problems
• Be armed with the knowledge for those real life problems yet to happen
• Share experiences with fellow colleagues
• Manage risks through Increased knowledge

Delegates

• Anyone with an interest in microbiology.
• Seasoned professionals for those looking for a Refresher course
• Anyone involved in the production of sterile and / or clean products
• Regulatory Affairs Professionals
• Quality Assurance, Quality Control Professionals
• Technicians
• Supervisors
• Students

Course Objectives

At the end of the course, delegates will be able to

• Demystify the secrets to the “black art” of microbiology.
• Gain a better understanding of how microbiology is important and how to control contamination levels.
• Hear how / why / what to investigate when there is a problem.
• Better understand how to use the data to conduct process improvements without impacting on the financial performance of the company.
• How to set up a microbiological control program to add value.
• How to audit the microbiological control process.

Course Content

• Introduction to microbiology
• Bioburden
• Sterilization
• Pyrogens
• Air borne and surface borne contamination
• Packaging
• Workshop
• Examination (optional)

Methodology

One day training course, presented by Jeff Vest.

There will be a mixture of presentations, discussions, workshop and an optional examination.

Presenter

Jeff Vest

With over 21 years of experience of microbiology in the healthcare industries, Jeff is Manager of the Medical Health Services of the UK office of TÜV SÜD Product Service.  Prior to this appointment Jeff has worked as a lead auditor for medical devices since 2004, for TÜV SÜD Product Service, specialising in sterile medical devices and sterilization technologies for all sterilization technologies.

Since 1999 Jeff has been Lead auditor for medical devices with two previous Notified Bodies, auditing medical device companies in Europe, Americas, Asia and Africa.

 Why choose TÜV SÜD Product Service

TÜV SÜD Product Service is the largest EU Notified Body for the Medical Devices Directive, with extensive experience in regulatory approvals. We provide a wide range of training services, sharing our expertise in product and quality system conformance.

Based on real life experiences, we provide you with valuable information in getting your products and services to market on a global basis.

Our expertise is supported by over 50 years’ experience in testing, certification and training, and by over 100 accreditations and approvals and have thousands of clients worldwide. 

For further information please contact Sandie Houghton, SHoughton@tuvps.co.uk.