Good Distribution Practices

The Center for Professional Advancement
Hoofddorp, Netherlands

Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced

Course 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.
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Phone:+31/20/638.28.06

School Address:

Corporate Office
Box 7077, 44 West Ferris Street
East Brunswick, NJ USA 08816-7077
Phone: (732)238-1600
Fax: (732)238-9113
Email info@cfpa.com

Europe Office
Oudezijds Voorburgwal 316A, 1012 GM
Amsterdam, The Netherlands
Phone +31/20/638.28.06
Fax +31/20/620.21.36
Email amsterdam@cfpa.com



Jobs & Resumes: Hoofddorp
Houses & Roommates: Hoofddorp

Non-Clinical Drug Safety Evaluation and Drug Development
Pharmaceutical Process Development
Packaging of Pharmaceuticals
Pharmaceutical cGMPs and FDA Inspections
Drug Product Stability and Shelf-Life
Pharmaceutical Water Systems
CMC Submissions in CTD Format
Gums and Hydrocolloids
Complaint Systems-The Essential Requirements
Choosing Sensors, Monitors and Instruments for PAT Programs
Lyophilization Technology
Hair Product Development
Drug Product Stability and Shelf-Life
Surfactants, Colloids and Interfaces
Crystallization Technology
Color Additives and Their Use in Decorative Cosmetics
Emulsion-Suspension Technology
Cosmetic Product Formulation
Vendor and Contract Supplier Qualification

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