About This Workshop

This interactive three-day Good Distribution Practice (GDP) and Responsible Person (RP) training workshop focuses on the key requirements for the distribution and storage of pharmaceutical products and materials. Our training enables delegates to understand and effectively implement the principles of GDP at their facilities, including the new Responsible Person-Import (RP-I) role to be implemented by the MHRA post-Brexit.

Why You Should Attend

This GDP and Responsible Person training course provides you with a thorough understanding of the regulatory requirements for operating within a storage and distribution center for materials or medicinal products in the pharmaceutical industry.

It also gives you a practical understanding of the systems and processes required to be implemented to ensure that your operation is compliant and delivers product that is safe and efficacious in an efficient manner.

Interactive discussion groups provide a great opportunity to network with others in the same industry and learn from their experiences.

This course is suitable for all levels of people involved in the handling and storage of medicines and pharmaceutical materials, from those working for multi-national companies distributing product worldwide to small independent warehouses wholesaling medicines.

Key Learning Objectives

By the end of our GDP and RP training course, you will:

  • Have knowledge of legislative requirements for the storage and distribution of excipients, active substances and medicinal products
  • Understand in further detail the role of the RP-I
  • Know the fundamental elements of good distribution and storage practices
  • Have practical examples and best practices of how to implement key systems
  • Have a wider network of professionals working in distribution

Workshop Outline

  • European requirements for GDP
  • Quality management system
  • Quality risk management
  • Change management
  • Deviations/corrective and preventive action (CAPA)
  • Personnel and training
  • Premises and equipment
  • Documentation
  • Operations and materials lifecycle
  • Qualification of customers and suppliers
  • Returns and complaints
  • Outsourced activities
  • Quality agreements
  • Self-inspections
  • Transportation
  • RP / RP-I role, duties and behaviors

Who Should Attend

  • Trainee RPs
  • RPs looking for a training refresher
  • New warehouse supervisors and managers or personnel who are new to GDP operations
  • Warehouse operatives, supervisors and managers who are new to the pharmaceutical industry
  • Auditors who are expected to inspect storage facilities
  • Personnel from new distribution operations

Course Tutor

Samantha Clack - Sam has worked in the pharmaceutical industry for over 20 years, and for more than 10 years as a Qualified Person. She is currently named on three licenses as the Qualified Person and has also been named as the RP on wholesale distribution licenses.

She has extensive hands-on knowledge of pharmaceutical manufacturing and distribution and has worked for large multi-national companies as well as smaller operations including virtual organizations.