INTRODUCTION FOR GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)
This course provide the participants with the knowledge and skills to conduct the internal audits of the QMS based on the relevant audit criteria like GDPMD. Participants will learn how to use process based approach in the internal audit and learn how to report on the effective implementation and maintenance of management system in accordance with ISO 19011.
LEARNING OBJECTIVE
The training provides:
- Understand the guidelines of QMS auditing accordance to ISO 19011:2018 and internal audit process from initiating, preparing, conducting audit activities, preparing and distributing the audit report
- To handle the non-conformance effectively and help the client understand the clause of GDPMD requirements
- To Develop your knowledge of how the requirements of respective standard like GDPMD are fulfilled and help the organization to fulfil the regulatory requirements.
COURSE BENEFITS
- prepare, conduct and follow up on respective standard like GDPMD audit activities
- the role of internal audit in maintaining and improving QMS with reference to the Plan, Do, Check, Act (PDCA) cycle
- Gain the skill to assess an organization’s capability to manage its QMS by using GDPMD clauses interpretation.
- Handle the non-conformity effectively based on the real life example from the auditor perspective
- Gain the skill to assess an organization’s capability to manage its QMS by using process- based approach
- Handle the non-conformity effectively based on the real life example from the auditor perspective
LEARNING METHODOLOGY
This course is designed for individuals involved in the auditing, maintaining and monitoring of QMS against GDPMD
COURSE SOLUTIONS
- This course can be run in-company around the world
- We can tailor the content to focus on your requirements.
- This approach makes perfect sense for groups of 4+ delegates, enhancing cost effectiveness as well as team bonding.
- Classroom accompanied by Lectures, real Experience Sharing, Role-plays, Interactive Group Activities, Experiences, Simulation Activities and Feedback
- Delegate manuals and certificates of Attendance will be provided
COURSE CONTENTS
Day 1
Module 1: Introduction to Auditing
- Potential benefits of internal auditing from the auditor perspective
- Understand the auditor competence and responsibilities
Module 2: The Process Approach and Process Auditing
- Understanding and meeting the requirements
- Looking at process in terms of added value and Obtaining results of process performance
Module 3: Non-conformity management
- Understanding the standard requirement based on the real-life example of non-conformity
- Case study
Module 4: Managing audit program
Understand the Plan, Do, Check, Act cycle
Day 2
Module 5: Practical internal audit
- Applying the process-based approach in audit
- Testing the understanding on the standard requirement
- Prepare audit conclusion and report
- Conduct audit follow up
- Q&A session
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