Principals of Good Distribution Practice Guidelines

Online Training Id: PQMS-005

Geographical Region: Global

Level: Intermediate

Duration: 2 hrs 

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This foundation course is for those wishing to be named as the Responsible Pharmacist (Person) for the Distribution of Medicinal products and is based on the international regulations for Good Distribution Practice (GDP) of pharmaceutical products for human use. The training reviews the practices of wholesale distributors and the proper ways and processes for the distribution of medicinal products, as well as the roles and responsibilities of all personnel stated in the GDP regulations. The course takes a detailed look into what are the most important aspects of GDP and provides all trainees with all the most relevant information needed for applying Good Distribution Practices in their work and looks into the practices of wholesale distributors and the proper ways and processes concerning the distribution of medicinal products, as well as the roles and responsibilities of all personnel stated in the GDP regulations. It discusses the new EU Guidelines 2013/C 343/01 and measures the impact of the new Falsified Medicines Directive and increasing standards required in a supply chain management.

Learning Objectives:

To understand the process required and the level of documentation, practice and training to comply with the correct storage and distribution of medicinal products

Who Should Enroll:

  • Qualified Person (registered  in accord with Article 49 of directive 2001/83)

  • Pharmacien Responsible(For part 2 refer to eLearning course – online training “The Focus of PharmacoVigilance as an integrated risk-benefit evaluation”

  • Technical Directors (GMP) (registered in accord with Article 49 of directive 2001/83)

  • Responsible Pharmacist (Responsible Person in UK)( For Wholesale distribution)

  • Technical Director (GDP) (For Wholesale distribution)Personnel in regulatory compliance

  • Distribution (includes drivers) & Warehouse staff

  • Supply chain management

  • Customer service

  • Pharmacy team members who want to wholesale medicines

  • Sales force

Author:

 

 

 

 

 

 

 

 

 

 

Pharmacist qualified from Chelsea College, London. Worked in retail and hospital pharmacy thereafter in UK and Saudi Arabia before moving into industry. During that time also did some lecture tours in India presenting best practices in compounding of parenteral drug products and safe practices in aseptic work. Also contributed to several articles in the Pharmaceutical Journal and the Cytotoxic Handbook. First industrial post was with Baxter Healthcare Australia gaining vast experience in manufacture of parenteral products and operation of a compounding unit. On returning to UK became principle pharmacist in running manufacturing unit of hospital which was also a commercial compounding unit. Having become a QP during this period left to join a pharmaceutical company. After 7 years with them following their re-location became a self-employed contract QP and RP to small and large companies. Still operating as a Consultant to the Pharmaceutical Industry 10 years on. Having being involved with different types of organisation as either QP or RP have extensive experience in GMP and GDP. These roles have involved auditing a variety of establishments i.e. laboratories, manufacturing sites for API’s finished products and storage sites.

Shashi Patel  

DIRECTOR, SOLOPHARM CONSULTANCY LTD. BPHARM(HONS) MRPHRAMS. QP

GBP $100.00

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