UK Good Distribution Practices (GDP) for the Pharmaceutical Wholesalers and Allied Sectors

This seminar is directed at companies in the UK interested in obtaining or maintaining an MHRA Wholesalers Dealers License.

The purpose of this one-day seminar is to evaluate Good Distribution Practices (Directive 2001/83/EU, Directive 2004/27/EC,EU Guidelines on Good Distribution of Medicinal Products for Human Use 94/C63/03) and to discuss these from the point of view of both industry and the authorities.

In addition, this course offers a practical explanation of the guideline for those who are active in the field of setting up and implementing GDP, as well as the management of quality systems for pharmaceutical products.

The seminar is highly interactive aimed at any pharmaceutical professional who wishes to increase their knowledge and understanding of the actual requirements of GDP.

Seminar Objectives:

The objectives of the course are that delegates will:

• Understand the regulatory requirements and constraints facing wholesalers and distributors of pharmaceutical products
• Become familiar with the relevant sections and clauses of the ‘Orange Guide'
• Develop their organisation's process and identify the controls necessary to ensure compliance with GDP regulations and guidelines

Target Sectors

Any company that has or is considering obtaining an MHRA Wholesale Dealer’s License such as:

• Pharmaceutical Manufacturers
  Pharmaceutical Suppliers and Contractors
• Active Ingredient and Excipient Manufacturers
  Wholesalers/Distributors
• Logistics Companies
  Contract Laboratories

Duration

1 Day

Target Audience

• Warehouse Staff
• Purchasing/Logistics Staff
• Customer Service Staff
• Sales staff
• Quality Control and Quality Assurance staff at all levels
• Regulatory and Compliance staff

Topics Include

• What is GDP and why is it needed
• GDP Per EU Directives/Regulations & Guidelines
• The Orange Guide
  MHRA- Hot Topics in GDP
• MHRA- Guidelines/expectations and perspective on GDP
• Counterfeit Products

Course Format

The course consists of formal content presentation interspersed with content quiz sessions, the presenters style involves intensive audience participation. The course may be modified to run in house in client companies.

About the Course Tutors

Aidan Madden is General Manager of FivePharma.com, a company offering tailored training courses to the Pharmaceutical and Allied Sectors. In addition FivePharma.com can provide Qualified Person services and assists in Quality Systems Development as well as offering contract auditing services. Aidan Madden has many years experience working for multinational pharma and biologics companies in various Quality Roles.