Quality Performance Improvement
Training Synopsis
This training is designed to establishment to demonstrate its ability to maintain quality, safety and performance of medical devices in compliance with the Malaysian medical device regulatory requirement throughout the supply-chain.
Introduction
Learning Objective
Duration
Methodology
Target Participants
Course Outline
Training Certificate
Why Us?
Introduction
GDPMD requires an establishment to demonstrate its ability to maintain quality, safety and performance of medical devices in compliance with the Malaysian medical device regulatory requirement throughout the supply-chain. This is a good training for beginner and person who wish to refresh their GDPMD understanding.
Learning Objective
By the end of the training, participants would be able to:
- To enable participants to understand in depth the requirements of GDPMD compliance.
- Enable participant comprehend the meaning of supply chain activities from product sourcing, procurement, transportation, delivery, storage, device tracking, installation, commissioning, service and maintenance, calibration and its relevance to manufacturing processes.
- To enable participants to establish, implement and effectively maintain the GDPMD quality system across the company’s entire supply chain activities.
- Enable participants to apply experiences and practices from ISO 13495 to:
- Extend of scopes in existing ISO 13485 QMS to include GDPMD clauses
- Integrating GDPMD specific requirements into existing ISO 13485 QMS
- Avoid duplication of system/processes which are relevant to both, thus optimizing resources
Duration
1 day (9.00am to 5.00pm) or duration proposed at quotation.
Methodology
Training session includes classroom lecture, exercises, group work and discussion.
Target Participants
Managers, Engineers, Executives, Supervisors of all departments/functions that are directly involved in the supply chain activities – Quality Assurance, Regulatory Affairs, Logistics/Planning, Warehousing, Purchasing, Installation, Commissioning and Servicing.
Other supporting team member that are indirectly related – production/manufacturing, plant engineering/utilities, Project Management are encouraged to participate as well.
Course Outline
- Introduction to Medical Device Regulatory Framework
- Definition of GDPMD, scope and application
- Purpose of GDPMD
- Organization and GDPMD Regulatory Compliance System
- Establishment responsibilities
- Resource management
- Supply-chain and device specific
- Surveillance and vigilance
Training Certificate
Certificate of Attendance will be issued to participants who fully participated the training and satisfied the attendance requirements.
Why Engage aNTS / Peplow-Warren?
Peplow-Warren Consultant Team is formed by a group of experienced sector expert, certification auditors, consultants and industry practitioners. They actively involve in international standard and specifications development by acting as active ISO and MOSTI Technical Committee Member. They carry a common mission: they are willing to share their good knowledge with current industry practitioners. Call us today for more detail. We are obliged to work together and grow your business.
Investment
Contact our Customer Care Hotline 012-713 3356 / 011-2128 4750 or email to ntsask@gmail.com / sales@peplow-warren.com for your best solution and offer.