Good Distribution Practice for the Regulated Industries

This course is designed to acquaint participants with the essential principles of Good Distribution Practice (GDP) within regulated industries. Its primary objective is to enhance comprehension of management concepts related to the handling, storage, and distribution of medicinal products and medical devices.

Key Components and Objectives:

• GDP Requirements Introduction: Delve into the foundational requirements outlined in Good Distribution Practice, offering a comprehensive overview of the regulatory landscape.
• Industry Relevance: Explore the specific applicability of GDP principles to regulated industries, emphasizing the importance of compliance for pharmaceuticals and medical devices.
• Regulatory Compliance: Understand how adherence to GDP requirements is integral to maintaining regulatory compliance and ensuring the quality and safety of distributed healthcare products.
• Risk Management: Explore the incorporation of risk management principles within GDP, focusing on strategies to identify, assess, and mitigate risks in the distribution process.
• Practical Implementation: Acquire practical insights into implementing GDP requirements within dayto-day operations, with a focus on real-world applications and case studies.
• Role of Technology: Recognize the role of technology in enhancing GDP, including the use of tracking systems, temperature monitoring, and other advancements that contribute to the integrity of the distribution process.

Content

Day 1

• GDP: Relationship and Integration with GMP
  • The definitions of Good Distribution Practice (GDP)
  • The relationship and integration of GDP with GMP along the supply chain
  • Scope of GDP
  • Comparing the requirements between GMP and GDP
• Understanding GDP Requirements
  • Quality Management
  • Personnel
  • Premises and Equipment
  • Documentation
  • Operations
  • Complaints / Returns / Suspected Falsified Products / Recall
  • Outsourced Activities
  • Self-Inspections / Internal Audits
  • Transportation

Day 2

• Applying Risk Management in the Supply Chain
  • Overview of the Quality Risk Management Process
  • Practical approach for the implementation of risk management to GDP compliance programs.
  • Consider FMEA
• Overview of Cold Chain Management
  • Definition and challenges of Cold Chain.
  • Regulations and guidelines on GDP, Cold Chain Management, and Mapping.
  • Essential requirements of temperature-controlled storage areas
  • Cold area qualification (including mapping) activities
  • Justification for re-qualification 

Participants

This course is suitable for Warehouse Managers, Supervisors, and operational personnel who are new to the industry, as well as well as for refresher or ongoing training (as required by the PIC/S Guide to GDP) of existing staff. It covers fundamental principles of GDP, as well as current trends and how to minimise human error.

Format and Course Length

The course will be delivered as an online virtual-classroom training session.

Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.

The training will be delivered as 2 full day sessions with breaks.

PDF Certificates will be provided to participants electronically.

What Do I Need?

Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.

Sessions

Times are based on Singapore time (SGT): UTC +8:00.

Participants to join at 8:45am in advance of a 9:00am start to address any technical issues.

Fee and Discount

• SGD $1,400 (excluding tax) per participant.
  • A 10% discount applies for 3 or more participants from the same company.

Course Registration and Payment

To register, please contact Biju Kishor at biju.kishor@seerpharma.com.au 

Contact us to discuss your interest in a public or private delivery of this course.

Refer to the Terms and Conditions