Medical Device Manufacturing Process Validation

21-22 August 2019 at E&O Hotel, Penang, 9am-5pm

MEDICAL DEVICE  MANUFACTURING PROCESS VALIDATION

EARLY BIRD COURSE FEES (until 15 July)
AMMI Member: RM 1,200 per pax
Non Member: RM 1,400 per pax

NORMAL COURSE FEES (from 16 July onwards)
AMMI Member: RM 1,400 per pax
Non Member: RM 1,600.00 per pax

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. Regulatory/QMS Compliance
1.1. QSR-21 CFR Part 820/ 21 CFR Part 11
1.2. ISO 13485:2016, GHTF/SG3/N99-10:2004 (Edition 2)

2. A Brief Introduction to Validation System
2.1. Process Validation/Software Validation System/Analytical Method Validation System
2.2. Cleaning Validation System/Packaging Validation /Sterilization Validation

3. Introduction to Process Validation
3.1. Overall Validation Program Description
3.2. Validation Definition
3.3 Process Validation Decision Tree
3.4. Types of Validation
3.4.1. Prospective Validation/ Concurrent Validation
3.4.2  Retrospective Validation/Revalidation

4. Validation Master Plan
4.1. Life Cycle Approach in Process Validation
4.2. Risk Assessment in Process Validation

5. Elements of Process Validation System
5.1. Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ)
5.2. Maintaining State of Validation
5.3. Deviation in Process Validation

DURATION
Two (2) full days

TRAINER’S PROFILE
Mr. Gobu Devarajan possesses a Master Degree in Electrical and Electronic Engineering and Certified Manager of Quality/Organizational Excellence (CMQ/OE, Certified Quality Auditor (CQA) from American Society of Quality (ASQ). Certified Six Sigma Green Belt.

He has more than twenty-five years of working experience with extensive knowledge in the field of Quality Engineering, Statistical Analysis and Quality System Requirements. He possesses excellent communication and presentation skills. He is capable of designing, conducting training programs and performs gap analysis according to QSR (21 CFR Part 820), ISO 13485, ISO 9001, ISO 16949 and ISO 14971. MDD 93/42/EEC, CMDCAS and JPAL

 

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: 800 3930 348
Bank: CIMB Bank
Swift Code: CIBB MYKL 

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