Good Supply Practice

Good Supply Practices have been developed by FDA officials and industry professionals across the Life Sciences industry (pharmaceutical/biotech and medical device) through a methodical Supply-by-Design process that increases the reliability of incoming supply, and therefore reduces the risk to finished product quality, patient safety and business success.

This impact of Good Supply Practices has been achieved by determining the root source of dysfunction affecting the integrity of supply and implementing sustainable solutions that can be tied to return on investment—such as increased safety, improved quality and enhanced reliability—commensurate with the need.

One of the most significant causes of supply chain failure is not understanding and aligning on what you need from a supplier partner to begin with.

Learn from the Experts who developed the GSPs

You will learn from our Good Supply Practice Consultants why supply chain failures occur and the how to prevent those failures from happening across your global supply chain from the experts who developed the Good Supply Practices (Xavier Health Certified Trainers). This workshop will provide hands-on experience with electronic tools developed by a team of FDA officials and industry experts through the following modules:

Setting the Foundation

Understand the underpinning paradigm shift that will lead you down a path of establishing a right-first-time supply chain. An overview of discovery will be shared to provide the foundation of “why” needed to effectively implement the Good Supply Practices.

First Things First:  Establishing the Right Cross-Functional Teams

The key to success for your supply chain to achieve Good Supply Practice is to gain cross-functional alignment on the key decisions regarding your product and supplier requirements. Learn a powerful methodology from our Good Supply Practice Consultants to establish the right cross-functional team for your company and product, which often leads to surprising discoveries that are historically missed.  This practical and easy-to-use tool will support your success.

Self-Qualification: Addressing True Root Cause to Your Supply Chain Failures

Module of the Good Supply Practices discovery is the role your own practices have in the failure of your suppliers. In an effort to address true root cause, this self-qualification process provides meaningful insight on which of your practices might be undercutting your own success. You will be given this powerful tool for immediate use within your company to ensure your supply chain is successful.

Internal Alignment on Material Requirements: Understanding your Product so Your Supplier Can Support Your True Needs

Through the Good Supply Practices development, it was recognized that companies often do not understand their own product well enough to know what requirements are needed for each material. This material requirements tool will support your ability to work cross-functionally to identify what you believe is critical to your end product. This process will improve your ability to identify the best supply chain partner throughout the lifecycle of the product.

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Internal Alignment on Supplier Requirements: Convergence for a Powerful Outcome

Suppliers have often commented that various functional groups from their clients contact them with disjointed and contradictory demands. The Good Supply Practices include a process for cross-functional alignment on the relative importance of a succinct and robust list of supplier requirements in order to identify the most appropriate supply chain partner for the product and overall business. The power of convergence leads to respectful and sustainable supply chain partnerships end-to-end for ultimate product and patient success.

Communication Strategy for Partnership Strength and Success

Communication is the key to a successful partnership and a Good Supply Practice, but do we know what to communicate, when to communicate, and why we are communicating?  Prepare your communication strategy such that your business is protected, your supplier is respected, and the appropriate information is communicated to someone who has the responsibility and authority needed to make timely decisions.

Holistic Supplier Qualification, For Every Supply Chain Situation

Making supply chain decisions based on partial information leads to a lifecycle of dreaded discovery. Your company can be set for success through a holistic supplier qualification process based on the outcome of internal alignment on material and supplier requirements, supplier engagement, and verification activities.  Understanding how to manage the outcome is a sign of a mature supply chain process—qualified, qualified with restrictions and why, and how/when to disqualify to help strengthen your Good Supply Practice.

Relationship Risk Mapping and Final Supplier Selection

Only through an understanding of self and supplier strengths and weaknesses can the best supply chain partner be identified for the needs of your company and the product at hand. Overlaying a map of strengths and weakness from both entities enables you to determine which risks are acceptable, and which risks need to be mitigated—and how. Don’t miss this opportunity to view your supply chain partners in a way you have never seen before, and one that leads to informed supply chain decisions.

Experience & Capabilities

  • FDA Compliance Consulting

  • Project Management

  • FDA 483 / Warning Letter

  • Consent Decrees

  • Systems Monitoring

  • GXP Training

  • Product Submissions

  • Due Diligence

  • Product Reviews

  • Registration & Listing

  • Audits

  • Gap Analysis

  • Regulatory Strategies

  • Inspection Preparation

  • GMP Services

  • GCP Services

  • FDA Submissions

  • Clinical Development

  • Nonclinical Development

  • Risk Based Assessment

  • Combination Products

  • Staff Augmentation

  • Electronic Publishing

  • Program Design

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