Risk management of raw materials in a cGMP environment is an area that is often overlooked as a Company develops new products. Depending on the product being developed, e.g., tablets and capsules vs. biotechnology products, as few as fifteen to twenty raw materials or as many as sixty need to be sourced and accepted before the process can be moved from initiation through completion. This live, interactive presentation will extensively review this area. It will also delve into the renewed issue of microbial and endotoxin contamination of these raw materials and why the FDA, EMA, and Health Canada have recently focused on them.

This live, interactive training webinar will also examine a variety of issues surrounding raw materials to include what materials should be tested and to what extent during Phases 1, 2, and 3. It will cover testing requirements during each Phase and what may be optional until the product moves to its next Phase. It will determine what options exist — even within a Phase 2 or Phase 3 testing framework. It will discuss compendial vs. non-compendial testing and how to respond when no method is available. The presentation will also discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay your initiation of testing.  Further, it will consider packaging and storage requirements and their impact on incoming materials, to include both raw materials and API.

The live, interactive training webinar will explore the number of lots required to be tested before reduced testing might occur, and why some Companies don’t accept this path. It will also review the use of individual samples vs. composite samples for testing. It will also consider the option of using the square root of “n” plus 1 vs the American Society for Quality (ASQ) methodology as an alternative sampling methodology.

Objectives

Implementing a proactive, risk-based approach to managing raw materials to ensure product quality, patient safety, and supply chain continuity in a GMP-regulated environment.

Key Learning Topics:

• Explain the importance of a risk-based approach to raw material management.

• Identify and categorize potential risks associated with raw materials (quality, supply, regulatory).

• Apply the principles of ICH Q9 (Quality Risk Management) to raw material controls.

• Utilize common risk management tools (e.g., FMEA) to assess suppliers and materials.

• Develop and justify risk-based control strategies, including sampling plans and testing frequencies.

Prerequisites: Basic understanding of GMP principles (e.g., 21 CFR Part 211, EU GMP Annex 1) and familiarity with raw material testing.

Key Topics 

• Module 1: Introduction & The “Why”
• Module 2: The Risk Management Foundation (ICH Q9)
• Module 3: Risk Assessment of Raw Materials & Suppliers
• Module 4: Implementing Risk Control & Strategy
• Module 5: Practical Application & Workshop
• Module 6: Documentation, Communication & CAPA
• Wrap-up, Q&A, and Post-Training Assessment

Who should attend?

• Quality Control
• Quality Assurance
• Regulatory Compliance
• Manufacturing, Procurement, Supply Chain
• Validation
• Research & Development
• Project Management

Assessment & Interaction

• Quizzes after key modules. 
• Group exercises (protocol drafting, data analysis).
• Feedback forms for continuous improvement.

Target Audience

• Roles: Stability scientists, QA/QC professionals, regulatory affairs specialists, formulation scientists. 
• Prerequisites: Basic knowledge of GMP, stability testing principles, and biopharmaceutical product development.

Key Takeaways 

• The Fundamental Mindset Shift: From Reactive to Proactive
• ICH Q9 is Your Roadmap, Not Just a Regulation
• Risk is Two-Dimensional: The Material AND The Supplier
• Use Simple, Effective Tools Like FMEA
• The Output is a Justifiable, Risk-Based Control Strategy
• Documentation is Your Evidence; Communication is Its Lifeline

Speaker

Kossi Molley, Chimiste, LSSBB, PMP