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 

• QMS Compliance- ISO 13485:2016/FDA 21CFR Part 820
• Benefits of Process Validation System
• Challenges in Process Validation System

2.    Types of Validation System. 

• Prospective Validation System
• Concurrent Validation
• Retrospective system

3.    Elements of Process Validation System 

• Validation Master Plan
• Installation/Operational/Performance Qualification
• Protocol/ Report
• Revalidation Activities
• Challenge Test

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
• Packaging Validation
• Sterilization Validation

​TARGET AUDIENCE

• 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 (admin@medsociate.com) 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 : admin@medsociate.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 admin@medsociate.com.
Medsociate Sdn Bhd   
(HRDF Approved Training Provider - Registration No. 4195) 
(AMMI Authorised Training Provider and Secretariat) 
Tel: +6010 4040 662  Fax: +603 2178 4347