Good Distribution Practice (GDP) Courses Offered by Global Regulatory Services (GRS)

 

Introduction

Global Regulatory Services (GRS) offers comprehensive Good Distribution Practice (GDP) training courses designed for professionals involved in the pharmaceutical supply chain. These courses aim to enhance understanding of GDP guidelines, ensuring compliance and maintaining the integrity of pharmaceutical products from the manufacturer to the end-user. The courses are available in various formats: In-House, Online, and Hybrid.

Course Offerings

1. Good Distribution Practice – GDP Operations Training

Duration: 1 Day
Certification: Valid for 2 years
Audience: Site Managers, Responsible Persons (RP), Account Managers, Operations and Administrative Staff, Warehouse Managers, and Personnel.

Agenda:

• GDP guideline overview
• GDP regulations and regulators
• Quality Management Systems (QMS) expectations
• Documentation and traceability
• Falsified Medicines Directive
• Critical GDP roles
• Storage and transport, equipment, cold chain
• Outsourcing and agreements, audits, self-inspections
• Controlled drugs
• Inspection deficiencies and how to avoid them

Fees:

• Individual Online (UK): £250
• Individual Online (EU): €270
• In-House Group (UK, max 8 people): £2600
• In-House Group (EU, max 8 people): €2800

2. Good Distribution Practice – Advanced Refresher GDP Course

Duration: 1 Day
Certification: Valid for 2 years
Audience: Same as GDP Operations Training.

Agenda:

• Basic GDP requirements and new legislation
• Overview of regulators
• QMS overview
• Documentation requirements
• Falsified Medicines Directive
• Storage and transport, cold chain, difficult situations
• Controlled drugs

Fees:

• Individual Online (UK): £160
• Individual Online (EU): €180
• In-House Group (UK, max 8 people): £2400
• In-House Group (EU, max 8 people): €2500

3. Good Distribution Practice – Driver GDP Course

Duration: 1 Day
Certification: Valid for 2 years
Audience: Drivers involved in GDP-related activities.

Agenda:

• Role of the regulator and GDP basics
• Drivers’ GDP responsibilities
• Quality Management Systems (QMS)
• Good Documentation Practice
• Vehicle inspection, suitability, security, hygiene
• Quality standards for premises and equipment
• Falsified medicines awareness
• Risks in transportation

Fees:

• Individual Online (UK): £250
• Individual Online (EU): €270

4. Good Distribution Practice – Driver Refresher GDP Course

Duration: 1 Day
Certification: Valid for 2 years
Audience: Drivers involved in GDP-related activities.

Agenda:

• Refresh knowledge of GDP
• Update on regulations
• GDP journey compliance

Fees:

• Individual Online (UK): £230
• Individual Online (EU): €250

 

Key Benefits

By attending these courses, participants will gain a practical understanding of GDP and will be able to implement the guidelines effectively in their roles. The training covers critical aspects of GDP, including regulatory requirements, quality management, documentation, and handling of pharmaceutical products.

For more information and to book a course, contact Tracey at tracey@globalregulatoryservices.com