Industry Expert Learning Series HRDF SBL Claimable
Medical Device Manufacturing Process Validation
INTRODUCTION The global medical device market is governed by various quality system requirements and regulations of different countries. Medical device manufacturers need to perform process validation in order to comply with regulatory requirements and ensure business success
COURSE OBJECTIVES This course provides regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program.
COURSE OUTLINE 1. Overview of Process Validation System
4. Statistical Tools and Techniques in Process Validation
Statistical Process Control/Process Capability
5. Brief Overview of Validation System
Software Validation System
Cleaning Validation System
Analytical Method Validation System
Quality managers, quality engineers and quality technicians involved in the development and manufacturing of medical devices.
Professionals directly involved in regulatory affairs, quality assurance, process development or manufacturing.
PRE-REQUISITES Familiarity with ISO 13485 and/or 21 CFR 280 is preferable but not mandatory
DURATION Two (2) full days
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 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