Individual and group training of your stability program personnel including online resources, discussion groups and industry peer organizations to help ensure knowledge and practices are up to date with industry and regulations.
Utilizing resources from third parties to ensure continuity of your stability program. Working effectively and compliantly with service providers and ensuring their compliance with your program requirements.
Research and activity required to ensure you have the resources, chamber space, materials, and disaster contingencies in place to complete a study. This planning is usually required before effective study design.
Includes all the things you do to ensure patient safety. This means compliance activities such as change control, writing procedures, preparing for, and hosting audits, data integrity and deviation (CAPA) documentation.
Ensuring positive interactions with regulatory agencies through compliance with their requirements, including their expectations for reports and submissions commiserate with the product life cycle, and studies representative of their climate zones.
After all resources and tests have been established, we document our study design in a protocol to ensure the study is reproduceable and meets the requirements of the product life cycle in question and is completed cost effectively.