Combination Product Risk Management Principles: Part 1

Frank Carroll

Course description

Managing the complex lifecycle of combination products requires the efficient utilization of resources of a pharma/device company regardless if the company is vertically integrated, utilizes bth in-house and contract manufacturing, or is a truly virtual company.

Part 1 of this will define and apply recognized risk management principles in the identification of required GMP’s and Quality Systems Regulations, developing a risk-based, tiered supplier and material qualification system, and developing effective Master Supply Agreements and Request for Quotations (RFQ’s).

The course is appropriate for all operations, quality, development, and project management functional areas but will emphasize the perspective of Engineering and Good Engineering Practices where applicable.

Upon completion of this course, you will be able to:

• Identify and understand the FDA classification of combination products
• Compare and contrast the use of risk management requirements from ICH, FDA, and professional engineering societies
• Identify the minimum GMP and QSR requirements for combination products
• Implement a risk‐based supplier and material qualification process
• Implement best practices for developing Master Service Agreements and Requests for Proposals/Request for Quote