Medical Device Change Control
29-30 August 2022
2 full days
Remote Online Training
8.30am – 5.30pm
Change is an inherent part of the lifecycle of a medical device. It can affect all aspects of Current Good Manufacturing Practice (CGMP), from research and development to production and supply. Change management is a concept that ensures change is implemented in compliance with quality and regulatory requirements. Change Control ensures that device modifications, manufacturing process changes, and supplier changes within the scope of your company’s quality management system are planned, approved and implemented in a controlled manner, maintaining the safety and efficacy of product and the effectiveness of the quality management system.
The course provides participants with an overview of the medical device change control and regulatory and quality management system (QMS) compliance. The participants will learn the elements of change control, change control master plan, risk management and the challenges in medical device change control process
- Introduction to Medical Device Change Control
1.1. What Change Control System
1.2. Definition of Change Control
- Change Control – ISO and Regulatory Requirements
2.1. Regulatory and QMS Compliance
2.2. FDA 21 CFR Part 820 – Quality System Regulation
- 21 CFR Part 820.30 (Design changes)
- 21 CFR Part 820.40 (Document changes)
- 21 CFR Part 820.70 (Production and process changes)
2.3. ISO 13485:2016 – Medical Device Quality Management System
- Control of documents and records (4.2.4 and 4.2.5)
- Quality management system planning (5.4.2)
- Management reviews (5.6.1 and 5.6.3)
- Review of product requirements (7.2.2)
- Design and development changes (7.3.9)
- Purchasing process (7.4)
- Process validation (7.5.6 and 7.5.7)
- Need for change (8.5.1)
2.4. EU MDR 2017/745 – Medical Device Regulation
- “Significant” Change Under EU MDR Article 120(3)
- Intended Purpose
- Design or Performance Specification
- Change Control Master Plan
3.1. Change Control Model
3.2. Change Control Process
3.3. Change Control Standard Operating Procedure
- Elements of Medical Device Change Control
4.1. Regulatory/QMS Changes
4.2. Change Control – All Aspects of the Medical Device Life Cycle
- Medical Device Design Changes
- Medical Device Material/Supplier Changes
- Medical Device Manufacturing Process Changes
- Medical Device Software Changes
- Medical Device Labeling/Packaging Changes
- Medical Device Sterilization Process Changes
- Medical Device Change Control and Risk Management
5.1. Application of Risk Management to Change Control
5.2. Risk-Based Approach in Change Control Process
5.3. Classifying Changes – Criticality and Complexity
- Challenges in Medical Device Change Control Process
6.1. Lack of visibility
6.2. Complexity of Changes Communication
6.3. Ineffective Documentation
6.4. Training not Integrated with Change
- Effectiveness of Change Control
7.1. Continuous monitoring
7.2. Post Market Surveillance
- Change Control – Benefits and Good Documentation Practices
8.1. Good Change Control Documentation Practices
Knowledge of medical device manufacturing and preferably an understanding of Quality Assurance or Quality Management System or Good Manufacturing Practices.
• Regulatory Personnel
• Quality Engineers
• Quality System Auditors
• Management representatives
• R & D staff
• Risk Management Team members
Mr. Gobu Devarajan possesses a Master’s 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 22 July 2022)
AMMI Member: RM1,272.00 per pax (incl 6% SST)
Non Member: RM 1484.00 per pax (incl 6% SST)
Normal Fees (Register from 23 July 2022 onwards)
AMMI Member: RM1,484 per pax (incl 6% SST)
Non Member: RM1,696.00 per pax (incl 6% SST)
Sign up for more than 6 pax, and enjoy special Group Registration Fee and Bonus Deal.
- Group Registration Package:
For group registration of 6 pax and above (up to 9 pax), the fee is RM1,166 per pax (inc 6% SST).
- Bonus Deal Package:
For group registration of 10 pax and above (up to 18 pax), the bonus deal are as follows:
– First 9 pax: RM1,166 per pax (inc 6% SST).
– 10th pax – 18th pax: RM212 per pax (inc 6% SST).
PAYMENT AND CONFIRMATION OF REGISTRATION
Option 1: HRD Corp Claimable Course Scheme
A quotation together with course outlines and course agenda will be sent to you for HRD Corp 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 (firstname.lastname@example.org) 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.
CANCELLATION, REFUND AND SUBSTITUTION POLICY
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|
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
Tel: +6010 4040 662