Category Archives: Uncategorized

ISO 13485:2016 Quality Management Systems

SOCSO Course Category:
Quality Management Systems

SOCSO Course Code:
HIT3046

Course Title:
ISO 13485: 2016 Quality Management System

Duration:
2 Days

Target Group:

  • Those involved in the Design, Production, Subcontract Manufacturing (including Sterilization, Aseptic Packaging etc.), Importation, Distribution, Installation, Servicing or appointed as Authorized Representatives in the Medical Device sector.
  • Anyone tasked with development of a QMS or conversion from ISO 13485:2003.
  • Management representatives.
  • Implementation team members.
  • Auditors (Internal or External /Supply Chain).
  • Quality Managers.
  • Regulatory Affairs personnel.

 

Target Industry:
Medical Device Manufacturing Industry

Certification:
Certificate of Attendance in ISO 13485:2016 Quality Management System by the Association of Malaysian Medical Industries

Course Objectives:
The new ISO 13485:2016 extends the scope to the entire medical device supply chain, introduction of the Risk Based Approach to QMS processes, with new as well as expansion of existing requirements and an increased focus on the organisations ability to meet applicable customer and regulatory requirement.

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.  This course also discusses the aspects of ISO 14971, which contains key principles and guidance for risk management.     

 Methods/ Methodology:

  • Lecture
  • Case Studies
  • Pre-Test & Post-Test

 

Course Content:

  • Overview of Requirements
  • Overview of the ISO 13485:2016 Standard
  • Interpretations of ISO 13485 Clauses
  • Transition to ISO13485:2016
  • Steps to Transition
  • ISO 13485 Linkage to Regulatory Requirements

 

Learning Outcomes:

Upon successful completion of the training, participants will be able to:

  • Understand Quality Management Terminology & Definitions (including revisions), Concepts and Guidelines.
  • Understand differences in objective evidence between ISO 13485:2003 and ISO 13485:2016 to be demonstrated.
  • Interpret All Clauses of ISO 13485:2016 to accurately address your company’s Role in the Medical Device Supply Chain.
  • Understand what is meant as Risk Based Approach, how it differs from Risk Management and how to evident its incorporation in to your ISO 13485:2016 based Quality Management System.
  • Learn World Class Practices to ensure Effective Implement of each Clause of ISO 13485:2016.
  • Understand requirements for Transition from 13485:2003 and ISO 13485:2016 – Timelines and Strategies.
  • Learn how to Prepare for an Audit and to Maintain ISO 13485:2016 Certification.
  • Understand relationship of ISO 13485:2016 and its roles in compliance to medical device regulations –Malaysia, ASEAN Medical Device Directive and the significantly amended EU regulations.

Labelling of Medical Devices (ISO15223-1)

SOCSO Course Category:
Manufacturing

SOCSO Course Code:
HIT3048

Course Title:
Labelling of Medical Devices (ISO 15223-1)

Duration:
1 Day

Target Group:

  • The Site Inspection Readiness Team, whom will be hosting, supporting & engaged in the Inspection, includes:
  • Regulatory Affairs personnel
  • Quality Systems personnel
  • Quality Assurance personnel

 

Target Industry:
Medical Device Manufacturing Industry

Certification:
Certificate of Attendance in Labelling of Medical Devices (ISO 15223-1) by the Association of Malaysian Medical Industries

Course Objectives:
Medical Device Regulations place great importance on information supplied by a manufacturer to the user so as to ensure the safe and effective use of a medical device. This can be seen being cascaded down into ISO 13485:2016 whereby labelling comprises of the label, the instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device.

In order to be in compliance, the usage of standards such ISO 15223-1 in conjunction with other recognized harmonized standards (both horizontal & vertical) need to be considered together with emerging requirement on unique device identification (UDI). These requirements vary in different regulated jurisdictions. Mistakes in labeling strategy may result in rejection during market authorisation or even prosecution and/or penalties.

Methods/ Methodology:

  • Lecture
  • Case Studies
  • Pre-Test & Post-Test

Course Content:

  • Labelling Requirements
  • Labelling of Medical Devices ISO 15223-Symbols

 

Learning Outcomes:

  • Upon successful completion of the training, participants will be able to: Understand proper application of labelling & provision of information to the user in ensuring safe & effective use of medical device(s)
  • Labelling of Medical Devices
  • The role of harmonized a& recognized standards and the need of use of non-harmonized / non-recognized standards
  • Risk Management and Usability Engineering considerations
  • ISO 15223-1:2016 versus EN ISO 15223-1:2016
  • European Norms to be utilized together with EN ISO 15223-1:2016
  • Significance of Regulation (EC) No 1272/2008 and Regulation (EC) No 207/2012
  • Unique Device Identification per CE Marking and US FDA requirements

Software Validation Requirements and Excel Spreadsheet Validation

SOCSO Course Category:
Manufacturing

SOCSO Course Code:
HIT3053

Course Title:
Software Validation Requirements and Excel Spreadsheet Validation

Duration:
2 Days

Target Group:

Target Industry:
Medical Device Manufacturing Industry

Certification:
Certificate of Attendance in Medical Device Manufacturing Process Validation by the Association of Malaysian Medical Industries

Methods/ Methodology:

  • Lecture
  • Case Studies
  • Pre-Test & Post-Test

Course Objective

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 Validation Requirements and Excel Spreadsheet Validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems.  Softwares 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 Content

  • Overview of Excel Validation System
  • Types of Software/Computer Validation System
  • Software Category
  • Excel Spreadsheet Development Lifecycle
  • Elements of Excel Spreadsheet Verification and Validation

Learning Outcomes:

Upon successful completion of the training, participants will be able to understand:

  • the requirements for Software and Excel spreadsheets used in production
    the quality system and case studies on how verification/validation can be accomplished
    the measures required to be in place to ensure system data are controlled and protected as well as ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

Effective Complaint Handling for Medical Devices

Course Title: Effective Complaint Handling for Medical Devices

SOCSO Course Category: Manufacturing

SOCSO Course Code: HIT3056

INTRODUCTION
The medical device industry is highly regulated due to the product risk to health and this risk is as well an important factor in complaint handling. This training program on medical device complaint handling is based on FDA regulations and the regulatory process as well as requirements from ISO 13485:2016 and MDR with respect to Medical Device Complaint Handling, including processes related to NCR and CAPA.

COURSE OBJECTIVE
This course will provide participants with an overview about handling of Medical Device Complaints, from receiving complaints, registration, classification, investigation, initiating and following up of corrective actions until reporting and closing of a complaint.

COURSE OUTLINE

  1. Requirements of Regulations and Standards (USFDA 21 CFR Part 820; ISO 13485:2016; MDR) related to Handling of Complaints
  2. Sources of Complaints, NCRs and CAPAs
  3. Selection criteria NCR/CAR/CAPA
  4. Complaint Handling – structure, templates & process flows
  5. Root Cause analysis / Problem solving tools
  6. Reporting to regulatory authorities
  7. Recall decision and process


TARGET AUDIENCE
Executives and managers and also quality personnel – anyone who may involve in the handling of complaints.


PRE-REQUISITE
Participants should have experience with or basic knowledge of quality management systems for the medical device industry. Basic awareness on medical devices, quality assurance and recognized standards (USFDA 21 CFR Part 820 & ISO 13485:2016) is also recommended.

 

DURATION
Two (2) full days


TRAINER’S PROFILE
Frank Ried is a German national living and working in Malaysia for more than 20 years. He holds a Mechanical Engineering Degree (Dipl. Ing.) from University of Kassel/Hessen (Germany). Frank is a Quality Engineer and Quality Auditor certified by EOQ (European Organisation of Quality) and DGQ (Deutsche Gesellschaft fuer Qualitaet). He is trained as Lead Auditor for ISO 9001, ISO 13485 and USFDA 21 CFR Part 820 requirements and has vast experience auditing and setting up compliance systems in these areas.

Frank has over 30 years of professional experience in the Medical Device manufacturing, pharmaceutical, personal protection and condom industry. He worked in two companies (B. Braun and Ansell) and various departments during this time.

Frank left Ansell at the end of 2016 to concentrate on his own company, Ried Q&C Consulting Sdn. Bhd., which he founded in early 2015. Frank now provides consultation in the compliance areas of ISO 9001, ISO 13485 and QSR (FDA) for Medical Device companies in Malaysia as well as Asia Pacific, fully utilising his expertise and experience in Quality Management, Assurance and Control. He also conducts training course as well as internal audits (incl. Mock-FDA Inspections) and supplier audits.

EU Medical Device Regulation (EUMDR)

Course Title: EU Medical Device Regulation

SOCSO Course Category: Manufacturing

SOCSO Course Code: HIT3055

Course Title:
EU Medical Device Regulation (EU MDR)

Duration
Two (2) days

Target Group
This training is recommended for Regulatory Affairs personnel, management and executive personnel with responsibility for medical device regulatory lifecycles, involvement with the design and implementation of quality management systems, or involvement with product design and development.

Pre-Requisite
Basic knowledge of the current Medical Devices Directive and/or Active Implantable Medical Devices Directive

Course Objectives
The new European Union Medical Device Regulation (EU MDR) replaces the Medical Devices Directive (MDD) in May 2017 and the deadline for compliance to EU MDR is May 2020.  EU MDR introduces numerous changes, including a shift from the pre-approval stage to more of a life-cycle approach. It also incorporates a variety of European guidance documents (MEDDEVs) into the regulation and emphasizes the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluations, and Post-Market Clinical Follow-up (PMCF). This training aims to help medical device manufacturers understand the additional requirements of the standard

Course Content

  • Scope, definitions and classifications
  • Conformity assessment and the role of Notified Bodies
  • General Safety and Performance Requirements
  • QMS requirements
  • Technical documentation requirements
  • Post-market surveillance, Post-market clinical follow-up, and vigilance
  • Clinical evaluation and clinical investigations
  • Transition and next steps

Learning Outcomes:

Upon completion of this course, learners will have acquired:

  • A good understanding of the European regulatory model according to the MDR 2017/745 and know how to apply the key principles.
  • Know how to use related product specific directives in conjunction with the MDR
  • Understand the combination products requirements and how to apply interactions with the directive for medicinal products, tissue of animal origin products and others as per demarcation guidance.
  • Make decisions on what clinical data are needed for CE-mark and how to safely keep the product on the market in compliance with the post market surveillance requirements of the MDR and related guidance documents
  • Apply the requirements for technical file and design dossier
  • Understand how Notified Bodies are designated and what their interactions are with MDCG and expert groups
  • Apply the UDI-DI requirements outlined in Annex VI