TRAINING

  • Good Distribution Practice for Medical Devices Interpretation
  • ISO 13485:2016 Interpretation
  • ISO 9001:2015 Interpretation
  • Good Distribution Practice for Medical Devices Internal Auditing Training
  • ISO 13485:2016 Internal Auditing Training
  • ISO 9001:2015 Internal Auditing Training
  • Medical Device Technical Documentation Training

GDPMD
INTERPRETATION

Overview

GDPMD is a stipulated requirement under the Malaysian Medical Device Act 737 and its accompanying Regulations affects parties involved in the distribution of medical devices. This course provides an introduction and interpretation of GDPMD and related guidelines.

Participants will gain proficiency on GDPMD development, implement and maintain the GDPMD Quality Management System in their organisations.

Course Objective
  • Understand the requirements of GDPMD
  • Ensure an efficient and successful medical device quality management system to improve and maintain compliance
  • Understand and implement the medical device regulations effectively
  • To gain knowledge and skill to establish the GDPMD regulatory system in their organisations
Course Content
  • Overview of the Malaysian Medical Device Regulation framework
  • Organisation & GDPMD Regulatory compliance system
  • Responsibilities of Authorised Representative (AR), Distributor and Importer
  • Resource Management
  • Supply Chain & Device Specific requirements
  • Surveillance & Vigilance
  • Strategy towards development and implementation of GDPMD
Target Audience/ Participants
  • Designated Persons
  • Quality Managers
  • Regulatory Affairs Managers
  • Auditors of Medical Device supply chain firms (internal and external)
  • Cross functional team members of implementation project
  • Persons who are responsible for GDPMD in organisations assuming either the roles of local Authorised Representatives, Distributors or Importers

ISO 13485:2016
INTERPRETATION

Overview

This course introduces the concepts required to understand, develop/upgrade, and deploy a quality management system as outlined in the medical devices quality management standard ISO 13485:2016.

Participants will be led by an experienced instructor in auditing, training and quality assurance as well as management system development. Participants will engage in small group activities and lively debates, additionally instructor will explore segments to gain the knowledge required to effectively manage changes brought by the new standard. Participants will acquire knowledge on application the principles to achieve and maintain medical device.

Course Objective
  • Understand the requirements of ISO 13485:2016 for medical devices and related services
  • Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
Course Content
  • Introduction
  • Overview of ISO 13485:2016 requirements
  • ISO 13485:2016 Quality Management Principles
  • Comparisons between ISO 13485:2016 and ISO 13485:2003 requirements
  • Documented information and ISO 13485:2016 implementation
Target Audience/ Participants
  • Quality Managers
  • Project Coordinators
  • QMS Executioners
  • QMS Consultants
  • Internal Quality Auditors
  • Companies requiring ISO 13485 Certification

ISO 9001:2015
INTERPRETATION

Overview

Effective management system enables to realize the transparent and stable processes. Through efficient communication, every function gets aware on their responsibilities to drive towards customer satisfaction and retain customer loyalty through company’s products or services.

When employee aware of their duties and objectives, this will boost motivation of employees towards cost reduction and mistake proofing. All these elements are the pulling factor in minimizing the RISK and increase of economic success by anchoring a continuous improvement process in the organization.

Course Objective
  • Able to explain on the impact to the QMS within the organization
  • Able to utilize the knowledge to adapt with ISO 9001:2015
  • Able to evaluate and perform gap analysis of organization towards upgrading to QMS
Course Content
  • Introduction of benefits of ISO 9001 to an organization
  • Understand ISO 9001:2015 Quality Management Principles
  • Process Approach
  • ISO 9001:2015 terminology and concepts
  • Overview of ISO 9001:2015 clauses
Target Audience/ Participants
  • Management Representatives
  • Quality Managers
  • Internal Auditors
  • Document Controller
  • Top Managements

GDPMD INTERNAL
AUDITING TRAINING

Overview

GDPMD is a stipulated requirement under Malaysian Medical Device Act 737 and its accompanying Regulations effects parties involved in the distribution of medical devices.

Participants will be led by an accomplished instructor with wide experience in auditing, training and quality assurance as well as management system development experience, including experience in assisting organisations in the implementation of the GDPMD. Participants will engage needed to effectively manage audits. Participants will learn how to apply these principles to produce effective internal audits on Establishments and their Outsource Service Providers.

Course Objectives
  • Recognize the relationship between GDPMD and Quality Management System (QMS)
  • Understand and apply the principles of GDPMD and ISO 19011 for value added auditing
  • Perform audits displaying auditing techniques and attributes
Course Content
  • Overview of the Malaysian Medical Device Regulation framework
  • Understand the Roles & Responsibilities of Authorized Representatives, Importers and Distributors in GDPMD as well as Post Market activities
  • Apply Principles of ISO 19011 in the auditing processes
  • Plan, conduct, and report effective Internal Audits for compliance to GDPMD
  • Familiarise with Audit interpretation of MDA/RR No. 1
Target Audience/ Participants
  • GDPMD auditors (internal & external)
  • Auditors of Medical Device Supply Chain (including assessments on Supplier/ Outsource Service Provider)
  • Designated Persons (GDPMD)
  • Personnel managing/ conducting Post Market Surveillance & Vigilance
  • Quality Managers
  • Regulatory Affairs Managers
  • Cross functional team members of system implementation projects

ISO 13485:2016
INTERNAL AUDITING TRAINING

Overview

This course introduces the concepts needed to understand, develop/upgrade, and deploy a quality management system as outlined in the medical devices quality management standard ISO 13485:2016.

Participants will be led by an experience instructor of auditing, training and quality assurance as well as management system development experience. Participants will engage in small group activities and lively debate, additionally instructor will explore segments to gain knowledge required to effectively manage changes brought by the new standard. Participants will acquire knowledge on application the principles to achieve and maintain medical device.

Course Objective
  • Understand the requirements of ISO 13485:2016 for medical devices and related services
  • Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
Course Content
  • Overview of internal auditing by applying ISO 19011 against the requirements of ISO 13485:2016
  • Pre-Audit preparation
  • Conducting the audit program
  • Reporting the audit
  • Follow-up activities after the internal audit
Target Audience/ Participants
  • Quality Managers
  • Project Coordinators
  • QMS Executioners
  • QMS Consultants
  • Internal Quality Auditors
  • Companies requiring ISO 13485 Certification

ISO 9001:2015
INTERNAL AUDITING TRAINING

Overview

Audit is an evidence gathering process. Audit evidence is used to evaluate how well audit criteria are being met. Audits must be objective, impartial and independent, and the audit process must be both systematic and documented. Internal audits are referred to as first-party audits. Organisation use internal audits as a tool to audit themselves for internal purposes.

In the context of ISO 9001:2015, an auditor is a person who collects evidence in order to evaluate how well quality management systems requirements are met. Auditors are expected to determine whether quality management systems comply with standards and other planned arrangements.

Course Objective
  • To provide in-depth understanding of the concepts of ISO 9001:2015 standard requirements
  • To provide the knowledge and skills for participants to plan and conduct effective internal audits on their management systems according to ISO 9001:2015
  • Enable them to report audit findings clearly and undertake effective follow-up audit on corrective actions taken to ensure continual improvement
Course Content
  • Understand on fundamentals of auditing process based from latest guidelines released by ISO 9001
  • Develop the audit program according to ISO 19011
  • Detail reviews on ISO 9001:2015
  • Identify the Correction, Corrective and Preventive Action and review the effectiveness of action taken
  • Prepare the audit checklist according to ISO 9001:2015 requirements
  • Audit reporting and reviewing the audit findings
Target Audience/ Participants
  • Management Representative
  • Quality Managers
  • Internal Auditor
  • Document Controller

MEDICAL DEVICE
TECHNICAL DOCUMENTATION
TRAINING

Overview

This course introduces the concepts required to understand and prepare the technical documentation according to Malaysian Medical Device Regulations 2012 and guidance documents on the technical documentation.

Participants will be led by an experienced instructor in auditing, training and quality assurance as well as management system development experience. Participants will engage in small group activities and lively debates.

Course Objectives
  • Identify the medical device classification rule and risk-based classification according to Medical Device Regulations 2012
  • Understand on the medical device grouping criteria
  • Understand the preparation of technical documents (CSDT & EPSP) for medical device registration in Malaysia
Course Content
  • Introduction
  • Medical device risk-based classification and classification rule
  • Medical device grouping
  • Element of Common Submission Dossier Template (CSDT) and document preparation
  • Essential Principles Safety and Performance Element and how to prepare
  • Post Market Surveillance documents
Target Audience/ Participants
  • Quality Managers
  • Project Coordinators
  • Medical Device Consultants
  • Regulatory Affairs