Category Archives: 2024 Training

Medical Device Manufacturing Process Validation

DATE: 9 & 10  September 2024  (Online Only)

TIME: 9.00am – 5.00pm

DURATION: 2 full-day course (8 hrs per session)

COURSE FEES:

AMMI Members –  RM1,652.40 per pax (including 8% SST)
Public –  RM1,852.40 per pax (including 8% SST)

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. 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)

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

3. 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

4. Validation Master Plan

4.1. Life Cycle Approach in Process Validation

4.2. Risk Assessment in Process Validation

Process Validation

5. 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

6. 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

7. Validation- Benefits and Good Documentation Practice

7.1. Good Validation Documentation Practice

7.2. Benefits of Process Validation

PREREQUISITE

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

 CONTACT

For enquiries, please email to learning@ammi.com.my

Tel: +6010 4040 662

ISO13485: 2016 Internal Audit

DATE: 24-25 September 2024

TIME: 9.00am – 5.00pm

DURATION: 2 full-day course (8 hrs per session)1

COURSE FEES

Price is inclusive of 8% SST

AMMI Member: RM1,998 per pax

Public/ Non Member: RM2,592 per pax

INTRODUCTION

Internal audit is a mandatory requirement of ISO 13485 2016 as it mandates the review and evaluation of the organisation’s quality management system QMS to evaluate its conformity with the ISO 13485 stipulated requirements, compliance with applicable regulatory requirements and whether the procedures within the QMS is effectively implemented.

An effectively conducted internal audit is crucial for the successful operation of a QMS as it provides documented audit results to the organisation which can provide inputs to the analysis aspect of business planning, and can contribute to the identification of improvement needs and necessary follow-up activities. And when an organisation closes the feedback loop it provides assurance that its product realisation processes are in a desired state of control.

This training is designed for participants who are new and also those seeking to enhance their auditing skill as it intends to produce a pool of internal auditors with the necessary skill and knowledge to conduct effective internal audits.

COURSE OBJECTIVES

To provide participants with the necessary competence to plan, conduct, record, issue reports and perform the necessary audit follow-up activities. This training will be based on the ISO13485 2016 requirements with informative guidance from the ISO 19011 2018 Guidelines for Auditing Management System in extension from ISO 13485.

• Understand the ISO 13485 requirements for an internal audit.
• Knowledge on the principals of auditing, managing an audit, conducting the audit and guidance on the evaluation of an auditor competence and personality to add confidence to the audit performance.
• Optimise participants auditing skill in line with the ISO 19011 2018 standard.

COURSE OUTLINE

• ISO 13485 2016 requirements on internal audit.
• Terminology and Types of audits
• Principals of Auditing
• Establishing, Implementing and Managing an audit program
• Conducting the audit:
  • Initiate the audit
  • Preparation for the audit
  • Develop the audit plan
  • Assign audit responsibilities
  • Audit work documents
  • Determine the audit sequence flow
  • Opening meeting
  • Review of requested documents and communicate
  • Audit evidence triangle and information verification
  • Generate Findings
  • Present Findings
  • Audit follow up
• Auditors competence

COURSE BENEFITS

At the end of the session, participants will:

• Gain an understanding to conduct an effective audit confidently to help your company to improve.
• Be knowledgeable on the perquisites prior to, during and after an internal audit.
• Gain practical knowledge and skill from the ISO 19011 2018 Guidelines for auditing management systems which reflects current ‘state of the art’.

TARGET AUDIENCE

This programme is designed for ALL functions and levels of an organization that need to gain knowledge and practical skills on internal auditing based on ISO 13485.

This programme is particularly useful to those managing the quality management system, and internal auditors.

PRE-REQUISITE

Participants should have completed prior ISO 13485 2016 QMS Training.

CONTACT

For enquiries, please email to learning@ammi.com.my

Tel: +6010 4040 662

ISO13485: 2016 Quality Management System

DATE: 12-13 November 2024
TIME: 9.00am – 5.00pm
VENUE: Eastin Hotel, Penang
DURATION: 2 full-day course (8 hrs per session)

COURSE FEES

INTRODUCTION

Medical device regulatory requirements are becoming more stringent throughout every step of a medical device life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes are compliant and ensure best practice in everything they do.

This internationally accepted ISO 13485 2016 standard sets out the requirements for a quality management system specific to the medical devices industry. Its implementation in a quality management system is mandatory for an organisation involved is one or more phases of a medical device life cycle either as a manufacturer, supplier or external organisation providing products which has to consistently meet customer and applicable regulatory requirements.

COURSE OBJECTIVES

Participants will be introduced to the concepts required to understand, implement and maintain an ISO 13485 2016 medical device quality management system (QMS).  Participants will also be imparted with the knowledge on the utilisation of mandatory requirements within an ISO 13485 2016 compliant QMS for the one or more stages of a medical device life-cycle.

• Introduction on the background of this standard currently in its third edition.
• An understanding of what is termed and defined as a medical device.
• Guided understanding of the of the ISO 13485 2016 clauses and its application.

COURSE OUTLINES

• An overview of the ISO 13485 2016
• Clause 1: Scope
• Clause 2: Normative References
• Clause 3: Terms and Definitions
• Clause 4: Quality Management System
• Clause 5: Management Responsibility
• Clause 6: Resource Management
• Clause 7: Product Realization
• Clause 8: Measurement, Analysis and Improvement

COURSE BENEFITS

At the end of the session, participants will;

• Gain an understanding of the intent of the various clauses.
• Be aware of the application of the clauses in its implementation.
• Be knowledgeable on the maintenance of the QMS effectiveness to reflect current ‘state of the art’.
• Fulfil the prerequisite competence prior to participating in an ISO13485 2016 Internal Audit training.

TARGET AUDIENCE

This programme is designed for ALL functions and levels of an organization who need to gain understanding of the requirements in the standard, especially organizations that has embarked on the journey and plan to be certified with ISO 13485.

This programme is particularly useful to those managing the quality management system, process owners and internal auditors.

CONTACT

For enquiries, please email to learning@ammi.com.my

Tel: +6010 4040 662

Risk Management for Medical Devices (EN ISO 14971:2019)

AVAILABLE SESSIONS

• 4 & 11 Oct 2024 (Online)
• 7 – 8 Oct 2024 (Ascott Gurney Hotel, Penang)

TIME: 9.00am – 5.00pm

INTRODUCTION

ISO 14971 is an ISO standard for the application of risk management to medical devices. ISO 14971:2019 was released mid-December, and the EN version was released on December 18, 2019 to replace the ISO 14971:2007 and EN ISO 14971:2012 respectively. The latest version EN ISO 14971:2019 +A11:2021 is released in 2021.

Main highlighted of the updates is as follows:

• The key concepts and core approach to risk management was maintained
• Clarification was added around the following:
• Production and post-production information
• Clinical benefits and risk-benefit analysis
• Update the guidance in the annexes
• Revise ISO/TR 24971- The Technical Report that provides guidance on the application of ISO 14971

• Informative Annexes would primarily reside in ISO TR 24971 because it is easier to update a Technical Report than it is a standard. A new Clause was added: Clause 2 on Normative References. As a result, all Clauses past Clause 1 are incremented by 1.
• While the Technical Report complements the standard, it is important to note that the information in ISO TR 24971:2019 serves only as a guidance, and not requirements. As well, the first 3 annexes in ISO 14971:2019 act as guidance, and not requirements. The ISO/TR 24971:20XX has not been released yet.

COURSE OBJECTIVE

This training aims to provide participants with a clear understanding and insight into the new EN ISO 14971:2019+A11:2021 requirements. The training takes a look at the major changes in 2019 updates/revision and also covers some of the commonly used risk management tools such as FMEA, FTA etc.

COURSE OUTLINE

• EN ISO 14971:2019+A11:2021 Requirements
  • Clause 1 Scope
  • Clause 2 Normative Reference
  • Clause 3 Terms and Definitions
  • Clause 4 General Requirements for Risk Management System
  • Clause 4.1 Risk Mgt Process
  • Clause 4.2 Management Responsibilities
  • Clause 4.3 Competence of Personnel
  • Clause 4.4 Risk Management Plan
  • Clause 4.5 Risk Management File
  • Clause 5 Risk Analysis
  • Clause 6 Risk Evaluation
  • Clause 7 Risk Control
  • Clause 8 Evaluation of Overall Residue Risk
  • Clause 9 Risk Management Review
  • Clause 10 Production and Post-Production Activities
• Review on EN ISO 14971:2012 Annex Z on Potential New Annex in EN ISO 14971:20XX
• ALARP Concept
• Summary
• Extra Information

TARGET AUDIENCE

Professionals from quality assurance, regulatory affairs, research and development, process improvement, manufacturing and others who involve and wish to understand how to apply and develop proper risk management documentation for product and process of medical device industry.

PRE-REQUISITES

Basic understanding of the ISO 13485:2016 and use of risk management tools such as FMEA is an added advantage. Previous knowledge of ISO 14971:2007 or EN ISO 14971:2012 is not required.

CONTACT

For enquiries, please email to : learning@ammi.com.my

Tel: +6010 4040 662