Medical Device Manufacturing Process Validation
DATE
8-9, 23-24 Sept 2021
DURATION
4 half-day courses (4 hours per session)
DELIVERY MODE
Online Training
TIME
Thursday – 1.30pm-5.30pm
Friday – 2.30pm- 5.30pm
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
- 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)
- 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
- 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
- Validation Master Plan
4.1. Life Cycle Approach in Process Validation
4.2. Risk Assessment in Process Validation
- 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
5.4. Change Control in Process Validation
- Statistical Tools & Techniques
6.1. Acceptance Sampling Plan
6.2. Measurement System Analysis
6.3. The 7 Basic QC Tools
6.4. Process Capability Analysis
6.5. Statistical Method and Data Analysis
- Validation- Benefits and Good Documentation Practice
7.1. Good Validation Documentation Practice
7.2. Benefits of Process Validation
TARGET AUDIENCE
Regulatory/quality systems professionals, manufacturing engineers, and process development engineers
Mr. Gobu Devarajan possesses 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 perform 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
Early Bird Prices (Register by 8 August 2021)
AMMI Member: RM1,272.00 per pax (incl 6% SST)
Non Member: RM 1484.00 per pax (incl 6% SST)
Normal Fees (Register from 9 August 2021 onwards)
AMMI Member: RM1,484 per pax (incl 6% SST)
Non Member: RM1,696.00 per pax (incl 6% SST)
PAYMENT AND CONFIRMATION OF REGISTRATION
Option 1: HRDCorp Claim under SBL-Khas Scheme
A quotation together with course outlines and course agenda will be sent to you for HRDCorp grant application upon confirmation of the training. Please send us the grant application number for our record upon submission.
Option 2: Self-paying
2a) Direct Bank-in or via E-Banking
An invoice will be sent to you within 3 working days upon your registration. Please note that any Early Bird Discounts (for registration within 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.
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.
2b) Direct Online Payment
You may choose to make credit card payment via Paypal. An invoice with payment link will be sent to your email address separately when you choose this option.
The organisers, AMMI/Medsociate Sdn Bhd 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/Medsociate Sdn Bhd. 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 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 Medsociate Sdn Bhd
Authorised training provider of AMMI
Email: admin@medsociate.com
Tel: +6010 4040 662
Fax: +603 2178 4347
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