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44 - PHR - Pharmaceutical Sciences


PHR 112 - Good Distribution Practices (GDP) for the Pharmaceutical Industry

Code Start Date Duration Venue Fees
PHR 112 21 February 2022 5 Days Istanbul $ 3950 Registration Form Link
PHR 112 18 April 2022 5 Days Istanbul $ 3950 Registration Form Link
PHR 112 13 June 2022 5 Days Istanbul $ 3950 Registration Form Link
PHR 112 08 August 2022 5 Days Istanbul $ 3950 Registration Form Link
PHR 112 03 October 2022 5 Days Istanbul $ 3950 Registration Form Link
PHR 112 28 November 2022 5 Days Istanbul $ 3950 Registration Form Link
PHR 112 19 December 2022 5 Days Istanbul $ 3950 Registration Form Link
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Course Description

The course provides an introduction to Good Distribution Practices (GDP) for the pharmaceutical industry and its role in ensuring the safety of pharmaceutical products when in transportation or storage. Good Distribution Practices requires an organization to demonstrate its ability to maintain safety and performance of the pharmaceutical industry throughout the supply-chain. It will be used by both internal and external parties to determine the ability of an establishment to meet the requirements specified within.

Course Objectives

  • Understanding how GDP add to the quality framework within an organization
  • Knowing how different departments function together with projecting quality, safety, and efficacy 
  • Being aware of the key elements to ensure the pharmaceutical industry quality along the supply chain
  • Understanding the reason for observing Good Manufacturing Practices (GMP) / Good Distribution Practices (GDP) rules
  • Developing a positive attitude towards GDP in particular

 

Who Should Attend?

  • Supply Chain Managers
  • Pharmacists
  • Health Auditors

Course Details/Schedule

Day 1

  • GDP Basic Knowledge
  • Temperature Mapping
  • Warehouse Validation
  • Pest Control
  • Document and Access Control
  • Premise and Facilities

Day 2

  • Cold Chain Management
  • Cold Room Temperature Mapping
  • Industry Best Practices : Backup Power , Alarm
  • Industry Best Practices : Holdover Test, Open Door Test
  • Industry Best Practices : Backup Storage Area
  • Repackaging and Relabelling Products
  • Cold Chain-Validation of Cold Box
  • Cold Chain–Validation of Vehicle

Day 3

  • Repackaging, Relabelling and Clinical Trial Product Management
  • Personnel
  • Production Area
  • Batch Production/Packaging Record
  • Line Clearance and Production
  • Reconciliation

Day 4

  • Clinical Trial Product - Specific Feature
  • Clinical Trial Product – Storage and Handling
  • Quality Management System, Risk Management and FAQ
  • Counterfeit Detection and Prevention
  • Supplier Evaluation

Day 5

  • Data Trending for Continuous Improvement
  • Contingency Plan
  • Deviation and Temperature Excursions
  • Internal Audit
  • Real-Life Findings