Industry Expert Learning Series HRDF SBL Claimable
Fundamentals of Sterilization, Concept to Market, Routine Validation and Control
INTRODUCTION Medical device manufacturing is both demanding and complex. The training course is designed to create better understanding of the Ethylene Oxide (EtO) and Gamma Sterilization process for the medical device manufacturing professionals in Malaysia.
COURSE OBJECTIVES The course will give participants an in depth perspective and practical examples of the Validation and Routine control of Ethylene Oxide Sterilization as well as Gamma Sterilization.
COURSE OUTLINE EO - Validation and Routine Control of Ethylene Oxide Sterilization.
Overview of Ethylene Oxide processing
What’s new in ISO11135:2014
Process Qualification of EO processes
Establishing and appropriateness of IPCDs & EPCDs
Parametric release for EO processes
Product & Process Equivalence
Laboratory tests associated with EO processing
Routine monitoring and control
Process failure investigation
Introduction – Gamma Irradiation, its principle and how it works
Requirements for Validation and Routine Control under ISO 11137:2015
Establishing the sterilization dose (minimum dose) – Dose Setting Method 1, 2 and VDmax
Establishing the maximum acceptable dose (maximum dose)
Validation process, IQ, OQ, PQ
Performance Qualification – practicality and common found problems
DURATION One (1) full day
PAYMENT Payment is required before/ on training date. Please choose from below options.
Option 1 : Direct Bank-in or via E-Banking upon receipt of Invoice Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice.
Please refer the following bank account details: Beneficiary Name: Medsociate Sdn Bhd Bank Account Number: 800 3930 348 Bank: CIMB Bank Swift Code: CIBB MYKL
Please email us (firstname.lastname@example.org) the bank-in slip / remittance slip once the payment is made.
For Government Sector A Local Order (LO) or letter of approval to participate must be presented before the training.
Option 2 : Direct Online Payment You can choose to make payment via Paypal upon receipt of invoice. When making payment, in the email section, please key in our Paypal Account : email@example.com
SUBSTITUTION Substitution is allowed for a registered participant. No refund will be made for cancellation.
CANCELLATION Medsociate Sdn Bhd (AMMI Authorised Training Provider) 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 if the cancellation is made by training provider. Cancellation of attendance and refund will not be entertained within 7 days of training date as all bookings would have been reserved and confirmed.
CONTACT For enquiries, please email to firstname.lastname@example.org. Medsociate Sdn Bhd (HRDF Approved Training Provider - Registration No. 4195) (AMMI Authorised Training Provider and Secretariat) Tel: +6010 4040 662 Fax: +603 2178 4347