10 December: Introduction to EtO Sterilization for Medical Devices

10 December 2019,  G Hotel Gurney, Penang
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Introduction to EtO Sterilization for Medical Devices

Venue: G Hotel Gurney Penang
Time: 9.00am-5.00pm

INTRODUCTION

Medical device manufacturing is both demanding and complex. The training course is designed to create better understanding of the Ethylene Oxide (EtO) sterilization process for the medical device manufacturing professionals in Malaysia.

 

COURSE OBJECTIVE

This course will give participants an overview of the EtO sterilization process, such as validation & standard, EtO routine process control, EtO residuals, safety & environmental control, handling EtO gas and biological indicator

 

COURSE OUTLINE

  1. Introduction
  2. Requirements for Validation of EO – ISO 11135
  3. EO Sterilizer Operation and EO Cycles
  4. Getting started on a new Microbiological validation
  5. Re-Qualification of EO – requirements of 11135 and TIR 28
  6. Other parts of the validation; EO residuals, packaging, etc..
  7. Problem Solving by Groups

 

TRAINER PROFILE

Mr Roslan Azman has more than 12 years’ experience in sterilisation – with extensive work experience in Medical Device Sterilization, specialising in EtO, and Gamma Sterilization as well as Medical Packaging. His experience was gained through his tenure with multinational med tech company, B Braun Medical Industries Sdn Bhd. In addition to sterilisation expertise, he also has experience in pharmaceutical quality control. He holds a degree in Applied Chemistry and diploma in microbiology from University Technology MARA.

 

 

TARGET AUDIENCE

Quality and regulatory affairs managers, engineers, technicians involved in the development, manufacturing and packaging of medical devices

 

DURATION
One (1) full day

 

COURSE FEES:

Early Bird Fees (Registration until  27 November)
AMMI Members: RM742 (inc 6% SST)
Non Members: RM848 (inc 6% SST)

Normal Fees (Registration from 28 November onwards)
AMMI Members: RM848 (inc 6% SST)
Non Members: RM954 (inc 6% SST)

PAYMENT AND CONFIRMATION OF REGISTRATION
All payment is due immediately upon receipt of invoice. Please note that a confirmation letter for HRDF submission will only be issued upon receipt of payment.

Option 1: Direct Bank-in or via E-Banking upon receipt of Invoice
An invoice will be sent to you within 3 working days upon your registration.  Please note that any Early Bird Discounts (for registration within the validity period) will be reflected in the invoice. Please email us (admin@medsociate.com) the bank-in slip/remittance slip once the payment is made. A confirmation letter for your HRDF submission will be issued to you upon receipt of payment.

Please refer the following bank account details:

Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 230-302-078-2
Bank: UOB Bank
Swift Code: UOVBMYKL 

 For Government Sector – A Local Order (LO) or letter of approval to participate must be submitted before your registration can be confirmed. 

Option 2: Direct  Online Payment
You may choose to make a direct online payment, via Paypal or your credit/ debit card. A tax invoice and confirmation letter will be sent to your email address within 3 working days, when you choose this option.

CANCELLATION / REFUND POLICY
AMMI reserves the right to cancel or postpone any training or event but with due notice to the registered participants/company (s). Any payment made will be refunded in full if the cancellation is made by AMMI.  No shows and cancellations made by participants/ companies within the specified period will incur the specified costs as per below schedule.

Prior to Training Date Cancellation Charges
30 days or more  No charges
15-29 days 25% of training course fee 
8 – 14 days 50% of training course fee
0 – 7 days 100% of training course fee

 SUBSTITUTION
Replacement of the participant is allowed at no additional cost if you are unable to attend. Please inform us of the replacement in writing at least 3 working days before the training date.

 

CONTACT

For enquiries, please email to secretariat@ammi.com.my
Tel: +6010 4040 662  Fax: +603 2178 4347