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45 - PHR - Pharmaceutical Sciences
PHR 112 - Good Distribution Practices (GDP) for the Pharmaceutical Industry
| Code | Start Date | Duration | Venue | |
|---|---|---|---|---|
| PHR 112 | 15 April 2024 | 5 Days | Istanbul | Registration Form Link |
| PHR 112 | 20 May 2024 | 5 Days | Istanbul | Registration Form Link |
| PHR 112 | 24 June 2024 | 5 Days | Istanbul | Registration Form Link |
| PHR 112 | 29 July 2024 | 5 Days | Istanbul | Registration Form Link |
| PHR 112 | 02 September 2024 | 5 Days | Istanbul | Registration Form Link |
| PHR 112 | 07 October 2024 | 5 Days | Istanbul | Registration Form Link |
| PHR 112 | 11 November 2024 | 5 Days | Istanbul | Registration Form Link |
| PHR 112 | 16 December 2024 | 5 Days | Istanbul | Registration Form Link |
Please contact us for fees
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
