Course Overview

Internal auditing is fundamental to any improvement initiative. The GDP Pharma standard requires an organisation conduct internal audits to determine the effectiveness of its GDP Pharma. Only Trained internal auditors can carry out these audits. This GDP pharmaceutical training course includes the clauses in GDP pharmaceutical. Participants will be taught how GDP pharma quality is maintained throughout the distribution network, so that authorised products are properly distributed throughout the supply chain and how to conduct internal audit on the requirements. Through practical workshop, case studies and role-play, delegate will gain the knowledge and skills to plan, conduct, report audit findings including follow up audit on corrective actions taken to ensure continual improvement.

Objective:

The programme aims to provide delegates with the knowledge and ability to
• To understand and involve in audit process
• To improve audit efficiency and effectiveness
• To understand objectivity and consistency in internal audit process
• To use auditing as a tool to monitor the performance of company Good Distribution Practice for Medical Devices Training

Target Participants

Brokers, distributors, logistics, transport & delivery companies, suppliers, warehousing, bio-pharma companies and any company who requires a Wholesale Authorisation Licence for medical device.
(A group of not more than 20 participants to ensure the effectiveness of the training.)

Agenda:

  • Day 1

    • 9am

      • Section 1 - Introduction to Auditing

      • Section 2 - GDP Pharmaceutical clauses overview

      • General requirements

      • Section 3- Opening meeting

      • Establish audit plan

      • Workshop

    • 1 pm – 2 pm

      • Lunch

    • 2 pm

      • Section 4 – Audit Checklists

      • Establish audit checklist based on GDP Pharmaceutical requirements

      • Workshop

      • Section 5 – Audit Process

      • Opening Meeting

      • Audit Method

      • Audit reporting

      • Closing Meeting

      • Section 6 – Audit Reporting and Follow-up

    • 5pm

    • End of course

      Certificate of Attendance will be awarded upon completion of course.

       

Training Methodology:

  • Classroom lecture, brainstorming, exercises, questions and answers.