Combination Product Risk Management Principles: Part 2
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
This course is intended for professionals involved in the Pharmaceutical, Medical Device, Biopharma and Biologics industries.
Managers, Directors and Specialists working in Engineering, Supply Chain, Manufacturing, Packaging, QA/QC and Project Management will benefit greatly by attending this training.
All operations, quality, development, and project management personnel who are involved in ensuring Good Engineering Practices should attend.