Son güncelleme: Ağustos 17, 2026

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GSYH ( İyi Dağıtım Uygulaması ) çevrimiçi kurs

Advantages Of Online Learning

 

In NBScience , a few of the biggest advantages of Good Disribution Practice online education are as under:

Öğrenci-öğrenci ve öğretim üyesi-öğrenci iletişimini geliştirir.

Students can share perspectives among themselves.

Instructors are more accessible.

Students experience a sense of equality.

It enables student-centered teaching approaches.

Different learning styles are accommodated.

Instructors can allow increased opportunity for student exploration.

There is an increase in rehearsal time thereby benefitting those who ‘learn by doing’

 

24/7 accessibility to GDP course materials is possible.

With continual availability of course contents, students no longer need to worry about accessing

it ‘in time’.

While traditional form of education forced physical participation, and distance Good Disribution Practice education wasn’t anything better, online learning makes it possible to altogether avoid physical attendance.

 

Tanım:

 

İyi Dağıtım Uygulamaları (GSYH) is a quality system for warehouse and distribution centers dedicated for medicines. Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards. The scheme ensures that consistent quality management systems are in place throughout your entire supply chain, from the early delivery of raw materials to the manufacturing plants, to the final shipment of finished drugs to the end user. An independent assessment of compliance against international GDP requirements is the most effective way to establish that your quality management system aligns with GDP guidance.

During the pharmaceutical GDP certification process, our highly-qualified auditors analyze your processes and policies, along with those of your supply chain partners to ensure that you consistently deliver good quality products as intended pharmaceutical manufacturers.

 

A valid GDP certificate by NBScience demonstrates that your organization is committed to quality in every aspect of your service, and to being a vital partner of the healthcare supply chain. Contact us to learn more about the Good Distribution Practices certification for Pharmaceutical Industry process.

programı:

 

Invited Trainers:

Dr.. Werner Gielsdorf, HSC- Almanya

BDT'deki Avrupa Komisyonu Tacis Projesi Genel Müdürü, UNCTAD'ın yöneticisi, DTÖ, ITC ,

AB, Dünya Bankası, UNCTAD/DTÖ,

GCP eğitmeni, GLP, GSYH,GMP

 

Dr.zadorin Eugene, Doktora, İşletme Yüksek Lisansı

Uluslararası Biyofarmasötik Birliği,

Gerson

Lehrman healthcare Council, First Clinical Research LLC Speakers

Büro, former head of consulting Group of the Department of Clinical Research

( 2006-2008 ).

 

The pharmaceutical industry has the responsibility not only to manufacture effective and safe products, but also to ensure that they are delivered to the patient in a safe and controlled manner. Management of the supply chain is a critical activity which requires adequately designed facilities, documentation systems and trained staff. Online GDP training course will cover the regulatory requirements developed by the EU and USA regulators as well as the WHO (World Health Organisation). Delegates attending this course will be provided with information on how to design and manage warehouses, select contractors, temperature map their warehouse, develop temperature monitoring system and manage transportation of their products. In addition guidance will be given on preparing SOPs, documentation and preparing facilities for EU/USA regulatory inspections. Interactive workshops especially designed to enable participant exchange views, share experiences with others and, our expert tutor while being guided through key aspects of pharmaceutical supply chain management.

 

Course will be of interest to the following industries:

Pharmaceutical/veterinary manufacturers

Biotech manufacturers

Vaccine manufacturers

Suppliers of vaccines

Healthcare providers

Supplier of services to the above industries

Hospital management

Wholesalers

Production managers

Qualified Persons/Responsible Persons

Project Managers

Procurement Managers

Quality Assurance managers/Quality Control Managers

Supplier Auditors

Regulatory Affairs Personnel

Dağıtım/Nakliye/Lojistik Yöneticileri

Dağıtım ve Lojistik Fonksiyonlarından Profesyoneller

Sözleşmeli Depo Yöneticileri

PROGRAM

Mevzuat gereklilikleri

AB Direktifleri

DSÖ Kılavuzları

Toptan Dağıtıma İlişkin AB Mevzuatı

Toptan Dağıtım Uygulamasına İlişkin AB Kılavuzları

Nitelikli Kişinin ve Sorumlu Kişinin Rolü

 

 

Tesisler ve tesisler

Tesis tasarımı

Temizlik & 'temizlenebilirlik'

Güvenlik ve ürün bütünlüğü

İnsanlar hareketi

Malzeme hareketi

Ürün ayrımı

Kontaminasyon/çapraz kontaminasyon kontrolü

Sıcaklık kontrolü & İzleme – ne gerekli?

 

Personel

Personel seçimi ve yeterliliği

GDP/GMP eğitimi

SOP Eğitimi

Eğitim kayıtları

 

 

Kalite Sistemleri

Dokümantasyon

Tanımlar Siparişler

Prosedürler

Kayıtlar

Doküman kontrolü ve bakımı

Belge Arşivleme

Eğitim paketlerinin hazırlanması

Prosedürler

Neyin gerekli olduğunu belirlemek

standart bir format ve yapı nasıl geliştirilir

SOP'ların yazılması

critical SOPs for a warehouse

preparing SOP training packages

Non Compliance Management

investigation of non-compliance

reporting and documentation

corrective action and preventive action planning (CAPA)

Returns Management

returns of non-defective medicinal products

security and QA decision

 

Emergency Planning and Recall

recall procedure

investigation and reporting

corrective action planning

 

Örnekleme

facility requirement

control of product and facility contamination

dokümantasyon

 

Stock Management

cycle counting

 

Ambalajlama & Re-labelling

facility and equipment requirements

SOPs and Documentation

staff training

 

Warehouse Management System

Developing specification

Vendor selection

Validation

 

Kendi Kendine Muayene

regulatory expectations

checklists

reporting and action planning

 

Contractors

Decision process for outsourcing

Contractor selection process

Quality/Technical agreement

Contract considerations

Audits of contractors

 

 

Transportation

Ulaşım modları ve sundukları zorluklar

Kara

deniz

 

 

Araç tasarımının dikkate alınması

Güvenlik sorunları

Sıcaklık izleme & kontrol

Uygunsuzluk raporlaması ve eylem planlaması

Soğuk Zincir Yönetimi

Developing specification

Tesis tasarımının dikkate alınması

Taşıma sorunları

Paketleme seçenekleri

Depolama ve taşıma sırasında izleme

Prosedürlerin geliştirilmesi

Eğitim ve kontrol

Spesifikasyon dışı durumlarla başa çıkmak

 

Sıcaklık Haritalaması

Deponuzun/treylerinizin haritasını çıkarırken dikkate alınması gerekenler

Tasarım hususları

Plan geliştirme

Test protokolleri

Riskli alanların belirlenmesi

Sıcaklık monitörlerinin yerleştirilmesi

Verilerin toplanması ve verilerin değerlendirilmesi

Raporlama – öneriler geliştirme

Kalifiye durumu nasıl korunur? -Devam eden bakım

 

Denetimlere Hazırlık

Kendi kendini denetleme programının geliştirilmesi

Eğitim sorunları

İç denetimler

Eylem planlama Kök neden analizi

Önleyici eylem

Maintaining inspection readiness status

 

Inspection findings

Most recent regulatory and client inspection findings