Category Archives: Upcoming Training and Workshops

5 – 6 July 2023: EUMDR

EU Medical Device Regulations (EU MDR 2017/745)

DATE: 5-6 July 2023

TIME: 8.30am – 5.30pm

DELIVERY MODE: Online Training via Zoom

OVERVIEW

The EU Medical Device Regulation (MDR) 2017/745 was published on 5th May 2017, and it has replaced the EU Medical Device Directive (MDD 93/42/EEC) and the EU Active Implantable Medical Device Directive (AIMDD 90/385/EEC). It came into force on the 25th May 2017, and all the related and relevant manufacturers have three years transition period to comply with the EU MDR. However, the European Parliament has adopted and supported the European Commission’s proposal to postpone the effective compliance and application of the EU MDR to 26th May 2021 due to the Covid-19 outbreak.

The 175-pages document outlined regulatory requirements to the economic operators (a manufacturer, an authorized representative, an importer and/or a distributor) as well as the notified bodies. The EU MDR also outlined the Rules (with added Rules compared to the previous EU Medical Device Directive) for medical device classification purposes.

The EU MDR compliance is important and mandatory for all existing economic operators that involved in marketing medical devices in the EU market as well as all economic operators who wish to expand their medical device distribution into the EU market.

COURSE OBJECTIVES

This course aims to give delegatesin-depth knowledge regarding the EU Medical Device Regulation and the course content outlined is to provide delegates with information on:

  • The structure of the EU Medical Device Regulation
  •  Who shall comply with the EU Medical Device Regulation
  • The Rules and Classifications of the medical devices
  • The Technical Documentation (Annex II and III of the EU MDR)
  • Clinical Investigation and Evaluation
  • Conformity assessment procedures

COURSE OUTLINE

Day 1: 

Opening and introduction

1.          Background of the EU Medical Device Regulation and its Structure

2.          The role and responsibilities of the economic operators

3.          Person Responsible for Regulatory Compliance

4.          Medical device Rules and Classifications

5.          Risk Management and Technical Documentation

 

Day 2: 

Day 1 Recap

5.          Risk Management and Technical Documentation (Continue)

6.          Clinical Investigation and Evaluation

7.          Conformity assessment procedures

8.          Course summary

COURSE BENEFITS

Upon completion of this training, delegates will have the knowledge on: –

  1. The purpose and structure of the EU MDR
  2. Who should be the appointed the Person Responsible for Regulatory Compliance
  3. Added Rules in the EU MDR for medical devices classifications
  4. The requirements on Risk Management Process and Technical Documentation
  5. The requirements on Clinical Investigation and Evaluation
  6. The different assessment route in accordance to Article 52 – Conformity assessment procedures

TARGET AUDIENCE

This program is very useful to delegates who handles EU MDR compliance and actively involved in EU MDR compliance planning and execution. However, this program is not restricted only to Quality and Regulatory Affairs personnel, personnel from other functions such as Design and Production will be benefited from this program as well.

Early Bird Prices (Register by 1 June 2023)
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 2 June 2023 onwards)
AMMI Member: RM 1,484.00 per pax (incl 6% SST)
Non Member: RM 1,696.00 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).

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 (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

 

26-27 June 2022: NCR/CAPA/ Complaint Handling

NCR /CAPA/ COMPLAINT HANDLING

Date: 26-27 June 2023

Time: 8.30am – 5.30pm

Delivery Mode
Online Training

INTRODUCTION

This course introduces the concepts needed to understand the requirements of NCR, CAPA & Complaint Handling under ISO 13485:2016 QMS and US FDA Quality System Regulation (21 CFR Part 820). And provide guidance on how to effectively address each of it with step-by-step process and root cause analysis & problem-solving tools.

COURSE OUTLINE

Introduction

  • Definition
    • NCR
    • Complaint Handling
    • CAPA
  • Standard and Regulatory perspective on NCR, Complaint Handling and CAPA.

 

NCR

  • What is Nonconformance?
  • Example of Nonconformance
  • Nonconformance process flow
  • Tips to Prevent Non-Conformance
  • Sample Template for NCR

 

Complaint Handling

  • What is customer complaint?
  • Why do customer complaint?
  • Complaint Handling Process
  • Rules of Complaint Handling
  • Tips of Effective Complaint Handling
  • Sample Template for Complaint Handling

 

CAPA

  • Intro
  • What is CAPA
  • Risk Based CAPA
  • Problem of CAPA
  • Why So Important
  • Cause of Confusion
  • Why Understand Difference So Important?
  • What’s the Difference Between Correction, Corrective Action, Preventive Action?
  • Steps to Create Risk Based CAPA Process
  • Sample Template for NCR
  • Learning from Experience- CAPA System Effectiveness
  • How CAPA Connects to NC and Complaint Handling

 

ROOT CAUSE ANALYSIS

  • Introduction
  • Challenge in Root Cause Analysis
  • Symptoms vs Cause of the Problem
  • Contribution Factor vs Root Cause
  • Root cause analysis problem solving model
  • Root Cause Analysis Tools
  • Root Cause Analysis in A Regulated Environment

 

TARGET AUDIENCE

Medical device quality professionals with knowledge of ISO 13485:2016 and FDA 21 CFR Part 820, individuals handling NCRs, CAPAs & Complaints, and those who news to medical device industry and would like to have better understanding on Nonconformance (NC), Complaint Handling and Corrective & Preventive Action (CAPA) to facilitate their implementation and improvements of their Quality Management Systems.

 

PRE-REQUISITES
An understanding of the ISO 13485:2016 and FDA 21 CFR 820 requirements is an advantage (not compulsory) and has work experience in the medical industry is recommended.

 

 

Early Bird Prices (Register by 1 June 2023)
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 2 June 2023 onwards)
AMMI Member: RM 1,484.00 per pax (incl 6% SST)
Non Member: RM 1,696.00 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).

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 (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

14-15 June 2023: Software Validation Requirements and Excel Spreadsheet Validation

Software Validation Requirements and Excel Spreadsheet Validation

DATE
14-15 June 2023

DURATION
2 full days

DELIVERY MODE
Hybrid –  Select from Classroom Training or Remote Online Training

TIME
8.30am – 5.30pm

VENUE:
Penang (Hotel to be confirmed)
Online training will be via Zoom.

INTRODUCTION / OBJECTIVES

Software Validation Requirements and Excel Spreadsheet Validation is a formalized, documented process for testing computer software and systems. The FDA and other regulatory bodies require Software and Excel Spreadsheet Validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems.  Software and excel spreadsheets used in GMP or GLP environments, as with any computer system, the regulatory bodies  expects measures to be in place to ensure system data are controlled and protected and to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. This training session shall explore the requirements for Software and Excel spreadsheets used in production or the quality system and case studies on how verification/validation can be accomplished.

 

 

COURSE OUTLINE

  1. Overview of Excel Validation System

1.1. Regulatory and QMS Requirements

1.2. Introduction to GAMP 5 requirements

1.3. 21 CFR Part 11 Regulations

 

  1. Types of Software/Computer Validation System

2.1. Computer System

2.2. Information System

2.3. Control System

2.4. Design system

 

  1. Software Category

3.1. Category 1 – Operating System

3.2. Category 3 – Standard Software Packages

3.3. Category 4 – Configurable Software Systems

3.4. Category 5 – Custom Built or Bespoke Systems

 

  1. Excel Spreadsheet Development Lifecycle

4.1. Project Planning.

4.2. Design

4.3. Development

4.4. Integration and Test

4.5. Installation and Acceptance

 

  1. Elements of Excel Spreadsheet Verification and Validation

5.1. Validation Master Plan

5.2. User Requirement Specification (URS)

5.3. Functional Requirement Specification (FRS)

5.4. Design Specification (DS)

5.5. Installation Qualification (IQ)

5.6. Operational Qualification (OQ)

5.7. Performance Qualification (PQ)

 

  1. Case Studies + Discussion

6.1. The “V” Model and how to apply it to software

6.2. Development of URS, FS, DS & Test Cases

6.3. Development of IQ, OQ and PQ protocols

6.4. Development of IQ, OQ and PQ report

TARGET AUDIENCE

Regulatory/quality systems professionals, manufacturing engineers, and process development engineers

This is a hybrid training course – you may select Classroom Training (Hotel) or Online Training (Zoom). The organiser reserves the right to switch to full online training by giving due notice to the registered participants.

Sign up for more than 6 pax, and enjoy special Group Registration Fee and Bonus Deal.

Course Fees – for 2 days Classroom Training (Hotel)
RM (inc 6% SST)
Online Training (Zoom)
RM (inc 6% SST)
Early Bird Course Fees (Registration by 27 May 2023)
AMMI Member  1,696.00 1,272.00
Non Member    1,908.00  1,484.00
Normal Course Fees  (Registration from 28 May 2023 onwards)
AMMI Member 1,908.00 1,484.00
Non Member   2,120.00 1,696.00
Package Deals
Group Registration > 6 pax                 1,590.00  1,166.00
Bonus Deal (10th – 18 pax)                    636.00    212.00

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 (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

7 June 2023: Failure Modes, Effects, and Criticality Analysis in Medical Device Manufacturing

Failure Modes, Effects, and Criticality Analysis in Medical Device Manufacturing

DATE
7 June 2023

TIME
9.00am – 5.00pm (1 full day)

DELIVERY MODE
Online Training

INTRODUCTION

FMECA is a proactive risk assessment, quality and cost improvement method. It is useful in pre-empting failure risks, and driving process improvement without having to deal with Statistical Tools. Participants will learn to systematically identify potential failure risks, quantify and prioritize these risks, and to work effectively in team to identify solutions to these risks.

COURSE OBJECTIVES

The course is design for the participants to:

  • Differentiate between Design and Process FMECA.
  • Assess risks in a systematic manner.
  • Quantify and prioritize risks.
  • Improve process within own department (point-kaizen).
  • Contribute to cross functional process improvement (flow-kaizen).
  • Engage staff through systematic analysis and improvement.

 COURSE OUTLINE

  • ISO 13485 and FMEA
  • Overview of Change and Risks
  • Introduction to FMECA
  • FMECA Overview
  • Failure Modes and Effects Analysis (FMEA)
  • FMEA Terminologies, Tools and Method
  • Criticality Analysis (CA)
  • FMEA Key Success Factors
  • Introduction to Process FMECA
  • The Five (5) Phases of Conducting FMEA
  • FMECA Tools.
  • Application Examples of FMEA

 

TARGET AUDIENCE

This programme is designed for operations and design staff who wants to learn a proactive method to manage and to continuously improve work processes, and to improve overall work effectiveness and efficiency.

Early Bird Course Fees (Register by 17 May 2023)
AMMI Members: RM636 per pax (inc 6% SST)
Non-AMMI Members: RM742 (inc 6% SST)

Normal Course Fees (Registration from 18 May 2023 onwards)

AMMI Members: RM742 per pax (inc 6% SST)
Non-AMMI Members: RM848 per pax (inc 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 RM583 per pax (inc 6% SST).

Bonus Deal Package:

For group registration of 10 pax and above (up to 18 pax), the bonus deal is as follows:

  • First 9 pax: RM583 per pax (inc 6% SST).
  • 10th pax – 18th pax: RM106 per pax (inc 6% SST).

 

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 (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