Good Distribution Practices
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Who Should Attend
This intensive and practical two-day course will be
beneficial to professionals in the pharmaceutical,
biopharmaceutical, medical device and other allied
industries. This material will be specifically worthwhile to:-
Scientists, Managers and Purchasing Managers
- Regulatory/Compliance Managers
- Quality Assurance and Quality Control Personnel
- Pharmacy and Dealership Managers
Description
Good Distribution Practices is based on Article 10 of
Directive 92/25/EEC of the Board of the European
Community governing the wholesale distribution of drugs
for human consumption.
The directive’s objective is to guarantee control of the
entire distribution chain, from the point of manufacture or
import to the point of being sold to the public. Drug
distributions comply with the principles and guidelines of
the directive. They must establish and maintain quality
assurance systems.
This course will provide a comprehensive overview of
Good Distribution Practices and the Quality Systems and
Procedures necessary to ensure compliance with the
directives from EU and other sources as well.
This two-day presentation will attempt to cover some of
the basic concerns related to global distribution of drug
products for human use. General requirements and
guidance from the EU, EMEA, WHO directives and other
sources will be discussed. Also, general preparedness,
quality assurance, counterfeit concerns, handling of
emergency situations, including EU guidance on product
recall, recall strategies and classification will be discussed.