Combination Product Risk Management Principles: Part 2

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 both in-house and contract manufacturing, or is a truly virtual company.

Part 2 of this training course will define and apply recognized risk management principles in developing effective and compliant Quality Agreements, tiered supplier monitoring, CAPA, validation and Change Control systems. It is recommended that participants attend Part I of this course.

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:

• Create effective and unambiguous Quality Agreements that comply with FDA Guidance’s
• Develop effective supplier and internal CAPA processes utilizing risk management principles
• Develop effective supplier and internal Change Control processes utilizing risk management principles
• Apply risk‐based principles to commissioning and validating equipment and systems
• Categorize significant changes from minor changes
• List the elements of ISPEs drug shortage initiative