GDP ( Good Distribution Practice ) online course

pharma distribution

If you are interested in GDP Audit – click here:  gmp audit

GDP ( Good Distribution Practice ) online course

Advantages Of Online Learning

 

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

It enhances student-to-student and faculty-to-student communication.

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.

medical congresses

 

Description:

 

Good Distribution Practices (GDP) 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.

 Programme:

 

Invited Trainers:

Dr. Werner Gielsdorf, HSC- Germany

General Manager of TACIS project of European Commission in CIS, Manager of UNCTAD, WTO, ITC ,

EU, World Bank, UNCTAD/WTO,

trainer of GCP, GLP, GDP,GMP

 

Dr.Zadorin Eugene, PhD, MBA

International BioPharmaceutical Association,

Gerson

Lehrman healthcare Council, First Clinical Research LLC Speakers

Bureau, 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

Distribution/Transport/Logistics Managers

Professionals from Distribution and Logistics Functions

Contract Warehouse Managers

medical congresses

PROGRAM

Regulatory requirements

EU Directives

WHO Guidelines

EU Legislations on Wholesale Distribution

EU Guidelines for Wholesale Distribution Practice

Role of Qualified Person and Responsible Person

 

 

Premises and facilities

Facility design

Cleaning & ‘cleanability’

Security and product integrity

People movement

Materials movement

Product segregation

Control of contamination/cross contamination

Temperature control & Monitoring – what is required

 

Personnel

Staff selection and qualification

GDP/GMP training

SOP Training

Training records

 

 

Quality Systems

Documentation

Definitions Orders

Procedures

Records

Document control and maintenance

Document Archiving

Preparing training packages

Procedures

Identifying what is required

how to develop a standard format and structure

writing SOPs

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

 

Sampling

facility requirement

control of product and facility contamination

documentation

 

Stock Management

cycle counting

 

Packaging & Re-labelling

facility and equipment requirements

SOPs and Documentation

staff training

 

Warehouse Management System

Developing specification

Vendor selection

Validation

 

Self Inspection

regulatory expectations

checklists

reporting and action planning

 

Contractors

Decision process for outsourcing

Contractor selection process

Quality/Technical agreement

Contract considerations

Audits of contractors

 

 

Transportation

Modes of transportation and challenges they offer Air

Land

sea

 

 

Vehicle design consideration

Security issues

Temperature monitoring & control

Non compliance reporting and action planning

Cold Chain Management

Developing specification

Facility design consideration

Transport issues

Packaging options

Monitoring during storage and transport

Developing procedures

Training and control

Dealing with out of specification situations

 

Temperature Mapping

What to consider when mapping your warehouse/trailer

Design considerations

Developing plans

Test protocols

Identifying the risk areas

Planting the temperature monitors

Collating data and data evaluation

Reporting – developing recommendations

How to maintain the qualified status -On going maintenance

 

Preparing for Inspections

Developing self inspection programme

Training issues

Internal audits

Action planning Root cause analysis

Preventive action

Maintaining inspection readiness status

 

Inspection findings

Most recent regulatory and client inspection findings

 

medical congresses

Tags: