Supply Chain Management and Supplier QA Program

Course Code: CPD/O/10/2021

CPD Hours: 14

The pharmaceutical supply chain involves multiple countries, partners, and handoffs, creating ongoing challenges in traceability, quality oversight, and regulatory compliance. In response, global regulators have continued to strengthen expectations to protect product integrity throughout distribution. As a result, all personnel involved in procurement, logistics, distribution, and supplier oversight play a critical role in maintaining a robust quality system and ensuring patient safety.

Key Learning Areas

• Overview of supply chain regulations
• How agencies such as FDA and EU authorities enforce compliance
• Roles and responsibilities across the supply chain
• Integrating risk management into distribution and supplier oversight
• Strengthening the Quality System to support continuous improvement

Day 1 Content

• Management responsibility in supply chain quality
• Current and emerging regulatory/customer requirements
• Cold-chain handling and storage controls
• Distribution process control and validation
• Documentation and record-keeping expectations
• Training and competency management
• Continuous improvement foundations
• Building an effective Supplier QA program (six-step approach)

Day 2 Content

• Recent regulatory trends in supplier management
• Essential SOPs and records for qualification and oversight
• Applying the six-step supplier quality planning model
• Identifying supplier risks and assigning risk ratings
• Developing Supplier Quality Agreements
• When reduced testing may be justified
• Managing suppliers operating within your own facilities

Participants

This course is for you if you have a level of responsibility for the quality and/or integrity of your organisation’s supply chain, specifically in relation to the procurement, supplier quality assurance, distribution and logistics of sourcing and supplying finished pharmaceuticals, pharmaceutical ingredients, and medical devices.

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

Participants will attend both full-day sessions.

Seats are limited: Only 25 participants per class

Fee

• HKD $4320 per participant

Course Registration and Payment

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

Refer to the Terms and Conditions