Good Distribution Practice Training

GDP Compliance in Practice and Regulatory Inspections

The aim of the course is to clarify GDP concepts and to help delegates get a feel for what questions inspectors might ask during regulatory audits, and what systems and practices they expect to see. In addition, it incorporates guidance on how those in positions of responsibility might go about ensuring compliance on a day-to-day basis, and also the right approach to preparing for, and dealing with, regulatory inspections.
After the training you will have a better understanding of:

• Consolidation of understanding of GDP principles
• Developing an awareness of what compliance means in practice
• Understanding the regulatory inspectors’ expectations
• Review typical deficiencies identified by the regulator

Who is if for?

• Delegates should understand the basic concepts of GDP (or GMP). A deeper understanding, while helpful, is not essential. The target audience includes:
• Manufacturing Quality Personnel overseeing Compliance in Warehousing, Distribution and Transportation Activities and/or reviewing Logistic Service Providers Compliance
• Warehouse and Distribution Supervisory and Management Staff
• Corporate Quality and Logistics Executives with input into overseeing Supply Chain Quality Compliance
• Authorised Wholesalers & Distributors.
  

• Pharmaceutical Manufacturers
• Medical Device/Diagnostic Manufacturers
• Supply Chain Service Providers
• Distribution Companies

Content:

• Overview / Summary of GDP principles
• Why quality systems?
• What is a Quality System?
• Where does ISO fit?
• SOPs (Standard Operating Procedures)
• Documentation
• Change control
• CAPA (Corrective Action / Preventative Action)
• Regulatory Audits and Self Inspection

Duration:

1 Day