This course aims to introduce the requirements of Good Distribution Practice (GDP) for the regulated industries and provide a better understanding of the concepts of management for the handling, storage, and distribution of medicinal products and medical devices.
- 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
- Premises and Equipment
- Complaints / Returns / Suspected Falsified Products / Recall
- Outsourced Activities
- Self-Inspections / Internal Audits
- 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
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.
|Day 1||14 November 2023||8:45am join for 9am-5pm|
|Day 2||15 November 2023||8:45am join for 9am-5pm|
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 email@example.com
Contact us to discuss your interest in a public or private delivery of this course.