INTRODUCTION FOR GOOD DISTRIBUTION PRACTICES FOR MEDICAL DEVICES (GDPMD) AWARENESS AND INTERNAL AUDITING

Distribution is an important activity in the integrated supply-chain of medical device. Various people and entities are generally responsible for the product sourcing, procurement, transportation, delivery, storage, device tracking, installation, commissioning, service and maintenance, calibration, need to be appropriately managed and controlled to ensure the safety and performance of medical devices at the point of use. In some cases, however, a person or entity is only involved in and responsible for certain elements of the distribution process. The level of risks associated with these activities may be of similar degree as those in the manufacturing environment and the lack of control over these activities may affect safety and performance of the devices. The Good Distribution Practice for Medical Devices (GDPMD) is developed to elucidate the requirements for an appropriate management and control of these activities.

COURSE OBJECTIVES

At the end of the seminar/workshop, the participants are expected to:

• Describe mandatory documentation requirements of GDPMD MDA/RR No.1
• Interpret the MDA standard requirement, implement and reporting
• Verification of compliance with requirements during Internal Audit

COURSE CONTENT

DAY ONE: GDPMD AWARENESS

• Regulatory Requirements for Medical Device Safety & Performance

• GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)
  • MDA/RR No 1: November 2015 [Appendix 4 Schedule 3 Medical Device Regulations 2012]

• PART 2: ORGANIZATION AND GDPMD REGULATORY COMPLIANCE SYSTEM
  • GDPMD Regulatory Compliance System- Documentation and Control

• PART 3: ESTABLISHMENT RESPONSIBILITIES
  • Responsibilities and authority
  • Management Review

• PART 4: RESOURCE MANAGEMENT
  • Personnel
  • Training, Competency and Awareness
  • Work environment
  • Cleanliness and Pest Control

• PART 5: SUPPLY-CHAIN AND DEVICE SPECIFIC
  • Authorization
  • Communication channel
  • Stock handling and stock rotation
  • Delivery to customer
  • Control of non-conforming medical devices
  • Disposal
  • Traceability
  • Control of outsourced activities
  • Secondary assembly and repackaging

• PART 6: SURVEILLANCE AND VIGILANCE
  • Medical device complaints
  • Distribution records
  • Field Corrective Action (FCA)
  • Field Safety Notices
  • Recall
  • Internal Audit
  • Mandatory Problem Reporting
  • Corrective and Preventive Action (CAPA)

DAY TWO: APPLICATION OF AUDITING PRINCIPLES

• Audit Execution

• • Audit techniques to gather objective evidence
  • Questioning technique and Body language

• Audit reporting/Follow Up:

• • NCR statement
  • Root Cause Analysis

• 5 Why Diagram
• Fishbone Diagram
• Fault Tree Analysis
• Process Flow Diagram

• • Correction, Corrective Action
  • Verification of Action Plan Effectiveness

• Interactive Group Discussions [Duration: 1.5 hours]-

1. • Workshop 1: Gathering Objective Evidence
   • Workshop 2: Writing of NCR statement and Audit finding classification (NC/OFI)

• APPLICATION WORKSHOP: LIVE AUDIT FOR 1.5 HOURS AND REPORT COMPILATION FOR SHARING WITH MANAGEMENT [1.5 HOURS]

• POST TRAINING WRITTEN ASSESSMENT [1.0 HOUR: MCQ AND SHORT ANSWER QUESTIONS]

• WORKSHOP 1: ASSESSMENT AND EVALUATION OF GDPMD COMPLIANCE DURING INTERNAL AUDIT- CASE STUDY

RECOMMENDED: 4.15PM – 4.45 PM POST TRAINING WRITTEN ASSESSMENT [MCQ AND SHORT ANSWER QUESTIONS] VIA ONLINE QUIZZIZ OR GOOGLE FORM

Exam Paper discussion: 4.45 PM- 5.00 PM