Supply Chain Management and Supplier QA Program

The pharmaceutical industry operates on a global scale, where active pharmaceutical ingredients, components, and products are procured through increasingly intricate supply chains. Recognizing the challenges posed by the limitations of individual countries' regulatory oversight, the US Government enacted the Drug Supply Chain Security Act (DSCSA) as legislation mandating a national track-and-trace system for medicines, including electronic tracing throughout the supply chain. This measure, enforced by the FDA since 2015, emphasizes the importance of ensuring the integrity of the pharmaceutical supply chain.

Simultaneously, the European Union (EU) has bolstered its Good Distribution Practice (GDP) requirements, which have been in effect for an extended period. These regulatory developments underscore the imperative for all personnel involved in your organization's supply chain to comprehend their roles and actively contribute to the implementation and maintenance of a robust and comprehensive quality system. This training will aim to focus an below;

• Global Regulatory Landscape: Understand the evolving regulatory landscape, particularly the DSCSA in the United States and enhanced GDP requirements in the European Union, and how they impact the pharmaceutical supply chain.
• Compliance Enforcement: Explore how these regulations are actively enforced by regulatory agencies such as the FDA, emphasizing the significance of compliance to ensure the safety and integrity of pharmaceutical products.
• Educating Personnel: Highlight the importance of educating all personnel in the supply chain about their roles and responsibilities, ensuring a collective effort towards maintaining compliance and quality standards.
• Risk Management Principles: Emphasize the integration of risk management principles within the quality system, illustrating how this approach can be instrumental in safeguarding product quality and 
  ensuring a consistent and reliable supply to customers.
• Continuous Improvement: Discuss the role of a comprehensive quality system in fostering continuous improvement within the supply chain, enabling organizations to adapt to regulatory changes and enhance overall operational efficiency.

Day 1 Content

You will develop a detailed understanding of the principles of responsible supply chain management and a framework for implementation and improvements. Specifically, you will learn the principles and practices of Quality and Risk Management Systems that you need to ensure the integrity of your supply chain, including:

• Management responsibility
• Regulatory and customer requirements: current and future
• Maintaining the cold chain
• Process control and validation
• Good documentation and record keeping practices
• Training
• Continual improvement
• Building A Successful Supplier QA Program – A Strategic Approach

You will be provided with an overview of the current regulatory requirements and expectations, along with a 6-step plan for managing your supplier quality so you can start reducing your supplier risks and improving your compliance.

Day 2 Content

You will gain an appreciation for:

• Recent changes and enforcement trends in regulatory requirements for supplier management
• SOPs and records needed for compliance and to prove effective supplier qualification.
• 6-step planning for managing supplier quality
• Identifying supplier risk factors
• Establishing supplier risk ratings and evaluation criteria
• Structure and content of the Supplier Quality Agreement
• Reduced testing considerations
• When the supplier is part of your organisation – Quality Agreements and the role of QA

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

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

• SGD $1400 (excluding tax) per participant
  • A 10% discount applies to 3 or more participants from the same company

Course Registration and Payment of Fee

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

Contact us for clarification or to discuss your interest in this course.

Refer to the Terms and Conditions