This 6-part virtual training provides an in-depth examination of the FDA’s approach to the regulation of combination products, including a review of the most current guidances and their interpretations, as well as an overview of the alignments and differences with the EU MDR's guidance.

Learn to identify how different countries and regions interpret what a combination product is and how those interpretations may impact the lifecycle of a combination product. The instructor will also guide you through processes to streamline and integrate the development of single entity, co-packaged and cross-labeled products. Discussion will also cover various approaches to aligning requirements to meet the regulations for the primary mode of action of a combination product.

The instructor will address FDA’s risk-based approach to combination products, including the called-out provisions in 21 CFR Part 4. The course will review how to meet the cGMP requirements commensurate with the risk of the product, integrating both risk and quality system management concepts. Relevant human factors processes will also be discussed in relation to the interface of the combination product, essential performance requirements, as well as post-marketing safety reporting considerations.

• understand key terminology and interpretations associated with combination products
• understand the FDA’s primary mode of action designation process
• understand differences in global interpretation
• understand the risk management framework for combination products
• review key called out provisions relative to applicable cGMP expectations

Module 1: Introduction to Combination Products

• Introduction to Medical Products and Combination Products
• What is a Combination Product?: A Global Perspective
• Key Terminology Dictionary & Thesaurus

Module 2: Combination Products cGMPs: A Risk Based Approach

• Combination Products Lifecycle: Risk Management Underpinning
• Combination Product Regulations & Guidance
• Quality System Expectations and cGMPs
• Quality System Expectations and cGMPs

Module 3: Combination Products Integrated Development

• Drug Development: QbD
• Device Development and Design Controls
• Purchasing Controls in the Combination Products Space
• Combination Product Integrated Development- What’s Unique and Challenges to Overcome
• SaMD and Combination Products

Module 4: Combination Products Risk Management

• ICH Q9, ISO 14971 & AAMI TIR 105
• Essential Performance Requirements (EPRs)
• Combination Products Human Factors
• Reliability

Module 5: Combination Products Lifecycle Management

• Post Marketing considerations for Combination Products
• Manufacturing, Supplier Quality, and Post Marketing Safety Reporting

Module 6: Combination Products Inspection Readiness

• Review of FDA Combination Products Compliance Program for CDER- and CDRH-led Combination Products.