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Validation of Ethylene Oxide Sterilization Print E-mail
An intensive one-day course to establish and improve compliance with ISO 11135-1:2007

Background
The course is designed to ensure delegates fully understand the new and revised requirements contained in ISO 11135-1: 2007, which is a major revision of the 1994 version of the standard. This standard addresses requirements for control and validation of ethylene oxide sterilization processes.

Learning Objectives
  • The course provides an excellent opportunity to:
  • Understand the importance of compliance with the requirements to ensure that the Sterility Assurance Level (SAL) is achieved for medical devices.
  • Understand the key steps in performing adequate validation in all stages of IQ, OQ and PQ.
  • Identify, plan and execute improvement to sterilization activities in a structured and efficient manner, to satisfactorily meet both business and regulatory responsibilities.
  • Ensure your needs are properly addressed in subcontract sterilization facilities used to sterilize your medical devices.

Course Format
The course presents ISO 11135-1:2007 comprehensively, uses lectures, discussions and group exercises. Each delegates will be provided with a comprehensive course manual, and copies of relevant regulations, standards and guidance documents are provided for the use of delegates during the course. Delegates will receive a Certificate of Attendance.

Contact us for detailed training agenda and prices
 

Latest News

Regulatory Updates

Two new guidance documents on Clinical Investigation: MEDDEVs 2.73/3 & 2.7/4

14-12-2010

FDA CDER (&CBER & CVM) Guidance for Industry: Process Validation: General Principles and Practices

24-11-2011

FDA CDRH: Medical Device Innovation Initiative

February 2011
 
Our 2010 Success

Although the 2010  economy was a difficult year for many businesses, we can look back with justified pride in our success and draw confidence that we can improve and grow our services to the health care industry in 2011, nationally and internationally.

Here are some brief statistics on our 2010 activities, which are indicative of our ongoing success

  • we provided major services to more than 24 medical device and drug facilities
  • we agreed service contracts with 12 new companies
  • we trained over 250 people in the industry, including Competent Authority personnel
  • we successfully project managed 3 FDA compliance inspections in the UK and China
 
Smithers UK (formally RAPRA) partners with Medicom
Medicom has successfully renewed its contract for 2011 with iSmithers to provide bespoke training for medical device polymer suppliers
 
DS Certificering A/S partners with Medicom
Medicom successfully renews contract for 2011 with DS Certificering A/S to provide public and in-house medical device training courses in Denmark.

Public Training Courses

Book now to secure your place on our remaining public training courses in 2011 Dates to be announced soon

Process Validation
Device Design
QS Regulation

Book now to secure your place on our remaining public training courses in 2011 at iSmithers, UK.

Medical Device Legislation and Material Selection

14-15 June

Shawbury, Shropshire, UK.

15-16 November

Shawbury, Shropshire, UK.

Book now to secure your place on our remaining public training courses in 2011 at DS Certificering, Copenhagen, Denmark.

Process Validation

3 May
Copenhagen, Denmark

Medical Device Design and Development Control

4 May
Copenhagen, Denmark

Establishing Compliance With ISO 11135-1:2007 for Validation of Ethylene Oxide Sterilization

5 May
Copenhagen, Denmark

 

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