Good Distribution Practice for Medical Devices (GDPMD) Effective Internal Auditing with Live Audit Training
Training Total Day & Time: 2 Days (9.00am to 5.00pm)
Objective of the Course:
- Understanding of GDPMD audit terminologies, audit methodologies, audit reporting on how to write correct non-conformance statement including proper completion and recording of investigation of causes, correction, corrective action taken and review the effectiveness of the corrective action taken.
Who should attend:
- Managing Director/ General Manager/ Top Management
- Head of Departments/ Sections
- Key personnel/ Supervisor/ GDPMD Team Members
- Internal auditors
Training agenda:
| Day1 | 9am~1pm |
Audit Terminology and Methodology
|
| 1pm~2pm |
Lunch Break |
|
| 2pm~5pm |
Workshop 1: Prepare Audit Program (40 minutes) What to look for when auditing key areas/ processes of Good Distribution Practice for Medical Devices (GDPMD) based on MDA/RR No 1: Nov 2015. |
|
| Day2 | 9am~1pm |
What to look for when auditing key areas/ processes of Good Distribution Practice for Medical Devices (GDPMD) based on MDA/RR No 1: Nov 2015 (continued). |
| 1pm~2pm |
Lunch Break |
|
| 2pm~5pm |
Workshop 5: Writing NC Statements and observations (30 minutes). End of Training |
