Category Archives: 2021 Training

28-29 Dec 2021: Test Method Validation

Test Method Validation

 

DATE
5-6 January 2022

TIME
8.30am – 5.30pm

DELIVERY MODE
Online Training

INTRODUCTION

The global medical device market is governed by various quality system requirements and regulations of different countries. Medical device manufacturers need to perform test method validation 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 test method validation requirements of the FDA’s Quality System Regulation, EU MDR  2017/745, ISO 13485 and other regulatory requirements on how to implement an effective validation program.

COURSE OUTLINE

  1. Regulatory/QMS Compliance

1.1  QSR-21 CFR Part 820

1.2  ISO 13485:2016, ISO 9001:2015

1.3  EU Medical Device Regulation (EU MDR 2017/745)

 

  1. A Brief Overview to Test Method Validation

2.1. Test Method Validation System

 

  1. Test Method Validation Master Plan

3.1 Overall validation program description

3.2 Life cycle approach

3.3 Risk assessment

 

  1. Introduction to Test Method Validation

4.1. Overall Validation Program Description

4.2. Validation Definition

4.3. Types of Validation

4.3.1. Prospective Validation/ Concurrent Validation

4.3.2 Retrospective Validation/Revalidation

 

  1. Test Method Validation Essential Characteristics

5.1. Accuracy

5.2. Precision

5.3. Specificity

5.4. Limit of Detection

5.5. Limit of Quantification

5.6. Linearity

5.7. Range

5.8. Robustness

 

  1. Elements of Test Method Validation/Software Validation

6.1. User Requirements Specification

6.2. Functional Requirements Specification

6.3. Design Specification

6.4. Installation Qualification (IQ)

6.5. Operational Qualification (OQ)

6.6. Performance Qualification (PQ)

6.7. Maintaining State of Validation

6.8. Deviation in Test Method Validation

6.9. Change Control in Test Method Validation

 

  1. Statistical Tools & Techniques

7.1. Gage Repeatability and Reproducibility

7.2. Measurement System Analysis

7.3. The 7 Basic QC Tools

7.4. Process Capability Analysis

7.5. Statistical Method and Data Analysis

 

  1. Test Method Validation- Benefits and Good Documentation Practice

8.1. Good Validation Documentation Practice

8.2. Benefits of Test Method Validation

PRE-REQUISITES

Knowledge of medical device manufacturing and preferably an understanding of Quality Assurance or Quality Management System or Good Manufacturing Practices.

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

 

 

Course Fees

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

8 November 2021: Acceptance Sampling Method

Acceptance Sampling Method

Date:

8 November 2021

Time:
8.30am – 5.30pm (1 full day)

Delivery Mode
Online Training

INTRODUCTION

Acceptance sampling plan is not process control; it is a batch sentencing method which protects the company from processes that are not capable and minimises nonconforming parts in inventory.

 

COURSE OBJECTIVES

This course is designed for the participants to:

  • Understand the definitions for acceptance sampling plan.
  • Apply AQL for quality assurance.
  • Interpret OC curve
  • Select the right AQL
  • Understand AQL relationship with the outgoing decision.
  • Differentiate between over sampling and under sampling.
  • Apply switching rules.

 

COURSE OUTLINE

  • Sampling Plan Concept.
  • Advantages & Disadvantages of Sampling.
  • Types of Acceptance Sampling Plan.
  • Inspection Approach.
  • Sampling Plan Graphs
  • Acceptable Quality Level (AQL) and Operating Characteristic (OC) Curve.
  • Overview of Acceptance Sampling Plan for Attribute ANSI Z1.4/ISO 2859.
  • Switching Rules and Acceptance Sampling Procedures.
  • Single Sampling Plans for Critical, Major and Minor Non-conformances.
  • Lot Formation and Random Sampling.
  • Rectifying Inspection.
  • AOQL, ATI and ASN.
  • Tightened and C=0 Sampling Plans.
  • Double Sampling Plan.
  • Acceptance Sampling Plan for Isolated Lot.

 

DURATION: 8 hours

MODE OF TRAINING

Remote Online Training

 

TARGET AUDIENCE

This programme is designed for anyone who wants to learn to develop sampling plan for quality assurance and control.

TRAINER’S PROFILE

Lim Lip Khoon (LK) is an engineer and a Six Sigma Master Black Belt. He has a Bachelor of Science in Mechanical Engineering and a Master of Business Administration. He has over 10 years of Operations Management experience at senior leadership level in manufacturing sector. He also has over 30 years of working experience in Operations, Process, Quality System and Business Process Improvement in a variety of industries in Australia, New Zealand, Malaysia, Singapore, China, Indonesia, and Thailand. He has worked with and at senior management level to improve process efficiency, implement practical Lean manufacturing systems and improve profitability.

 

Together with the University of Auckland, he has presented the Lean Six Sigma methodology and mentored candidates from industries such as telecommunication, banking, infrastructure, manufacturing, and others. Beyond the University of Auckland, LK had also delivered Six Sigma training for Melbourne University (Australia) and Telkom University (Indonesia).

 

Apart from being a principal of NexMU Sdn. Bhd., he is also a pioneer in Motorola University in the APAC region. He played a significant role in developing, enhancing, and customizing the Lean Six Sigma program for Motorola University. Also, he has coached and consulted Motorola University’s clients on the Lean Six Sigma Business Improvement Campaign. In addition to consulting, he has trained Six Sigma and Lean Green and Black Belts candidates in Australia, New Zealand, Peoples Republic of China, India, Malaysia, Singapore, Indonesia, and Thailand. He is currently also serving as an advisor to senior leadership for companies in a variety of industries, some of which are multinationals (MNC).

 

COURSE FEES

Course Fees (Register by 5 November 2021)
AMMI Members: RM636 per pax (inc 6% SST)
Non-AMMI Members: RM742

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.

CANCELLATION / REFUND 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

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

21-22, 28-29 Sept 2021: US FDA 21 CFR Part 820 – Quality System Regulation

US FDA 21 CFR Part 820 – Quality System Regulation

DATE
21-22, 28-29 Sept 2021

TIME
8.30am – 12.30pm

DURATION
4 half-day courses (4 hours per session)

DELIVERY MODE
Online Training

 

INTRODUCTION

The US FDA 21 CFR Part 820 – Quality System Regulation was developed and published to regulate and monitor medical devices and their life-cycle activities. The US FDA 21 CFR Part 820 outlines the current good manufacturing practice (cGMP) guidelines for the manufacturers and other relevant organizations to ensure the efficacy and safety of the medical devices.

 

Compliance with the regulatory requirements is crucial to ensure constant device supply and benefits to the users. A thorough understanding of the regulatory requirements is necessary to ensure effective implementation and continuous compliance. It will also elevate the confidence level in the manufacturers to prepare and host periodic FDA inspections.

 

COURSE OBJECTIVES

This course aims to help delegates to understand the UD FDA 21 CFR Part 820 requirements and get themselves ready for the FDA inspection. The consultant will also share practical examples to help delegates to understand the content better and guide them on effective implementation of the requirements.

 

The course content outlined is to provide delegates with:

  • Understanding on the role and responsibilities of the US Food and Drug Administration (FDA)
  • Knowledge and interpretation of the 21 CFR Part 820 requirements
  • Simple practical implementation examples
  • Readiness for the US FDA inspection

 

COURSE OUTLINE

  • Opening & Introduction
  • The US Food and Drug Administration
  • The Federal Food, Drug, and Cosmetic Act (FD&C Act)
  • The Code of Federal Regulations
  • 21 CFR Part 820 (Subpart A-O)
  • FDA Inspection – The Expectation and Preparation
  • The FDA inspection outcomes
  • Summary

 

COURSE BENEFITS

Upon completion of this training, delegates will: –

  1. Have a good understanding of the US FDA CFR Part 820 requirements
  2. Be able to put the requirements into effective implementation
  3. Understand the FDA inspection process and the expectation

TARGET AUDIENCE

This programme is designed for ALL functions and levels of an organization who need to gain understanding of the FDA 21 CFR Part 820 requirements, especially organizations that has embarked on the journey and plan to expand their market reach to the United States of America.  This programme is particularly useful to those managing the quality management system, process owners and internal auditors.

Kenny Chong is the General Manager at Quintas Consulting Sdn Bhd where his role also includes maintaining top quality training, consultancy and coaching service for Medical Device & other regulated industries.  He has been involved in the Medical Device Industry for the past 14 years, working with Straits Orthopaedics, Symmetry Medical, Neville-Clarke as well as BSI Services. In this time, his experience throughout the entire product lifecycle and all 3 medical device regulatory stages has enabled him to gain qualification on all medical device technology scopes.  He is a trained CQI & IRCA Lead Auditor of ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2007 as well as ISO13485:2016.

Early Bird Prices (Register by 22 August 2021)
AMMI Member: RM 1,272.00 per pax (incl 6% SST)
Non Member: RM 1,484.00 per pax (incl 6% SST)

Normal Fees (Register from 23 August 2021 onwards)
AMMI Member: RM 1,484.00 per pax (incl 6% SST)
Non Member: RM 1,696.00 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

8-9, 23-24 Sept 2021: Medical Device Design Control

Medical Device Design Control

DATE
8-9, 23-24 September 2021

DURATION
4 half-day course (4 hours per session)

DELIVERY MODE
Online Training

TIME
8.30am – 12.30pm

INTRODUCTION

Design Control is a substantial element of Quality System Regulation FDA 21 CFR Part 820 and ISO 13485 standards for medical device industries. Manufacturers must establish a robust design control processes to ensure develop a safe and effective finished product thus complies to regulatory requirements. This interactive course engages the participants with in-depth discussion of industry best practices to learn how industry leaders address design control challenges.

 

COURSE OUTLINE

  1. Regulatory/QMS Compliance

1.1. QSR-21 CFR Part 820/EU MDR 2017/745

1.2. ISO 13485:2016, GHTF.SG3.N99-9

 

  1. Introduction to Design Control

2.1. What is Medical Device Design Control Process

2.2. Application of Design Control-Waterfall Design Process

  1. Medical Device Classification

3.1. European Medical Device Classification

3.2. US FDA Device Classification

 

  1. Implementing Design Control

4.1 Design & Development planning [21 CFR 820.30 (b)]

4.2 Design Inputs [21 CFR 820.30 (c)]

4.3 Design Outputs [21 CFR 820.30 (d)]

4.4 Design Reviews [21 CFR 820.30 (e)]

4.5 Design Verification [21 CFR 820.30 (f)]

4.6 Design Validation [21 CFR 820.30 (g)]

4.7 Design Transfer [21 CFR 820.30 (h)]

4.8 Design Changes [21 CFR 820.30 (i)

4.9 Design History file [21 CFR 820.30 (j)]

 

  1. Principles of Risk Management for Medical Device Design

5.1 Integration of risk management into the design and development lifecycle

5.2 Integration of risk assessment/risk management/ per ISO 14971:2019

 

  1. Design Control and Usability Engineering

6.1 Application of usability engineering in medical device design

 

  1. Design Control – Quality System Inspection Technique

7.1 QSIT inspection techniques for Design control

 

  1. Design Control Case Studies

8.1 Design control scenarios

TARGET AUDIENCE

  • Regulatory Personnel
  • Quality Engineers
  • Quality System Auditors
  • Management representatives
  • R & D staff
  • Risk Management Team members

PRE-REQUISITES
Basic knowledge of medical devices and quality systems would be beneficial.

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

 

 

Normal Fees
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