9-10 November 2020 : Introduction to EtO Sterilization for Medical Devices

INTRODUCTION TO ETO STERILIZATION FOR MEDICAL DEVICES

Date: 9-10 November 2020
Time: 9am – 12.30pm

DELIVERY METHOD:
Online Training

DURATION:
2 sessions over 2 days (3.5 hours per session)

COURSE FEES
EARLY BIRD COURSE FEES (BY 26 OCT 2020):

AMMI Members: RM 636 (inc 6% SST)
Non Members: RM 848 (inc 6% SST)

COURSE FEES (FROM 27 OCT 2020)

AMMI Members: RM 742 (inc 6% SST)
Non Members: RM 954 (inc 6% SST)

INTRODUCTION
This 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 in depth perspective and practical examples 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 to EtO Sterilization
  2. Comparison of EtO to other sterilization methods
  3. Introduction to Microorganism(s)
  4. Sterilization Process, Media & Equipment
  5. Validation of EO Sterilization Process
  6. Understanding of Sterility Assurance Level
  7. EO Residual Requirements

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

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.

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

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:

Bank Account 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.

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.

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