Support your program in achieving transformative change that benefits your research enterprise while elevating the professional growth of the team. These events integrate education with facilitated work.  Our approach leverages proven strategies in leading successful multi-disciplinary strategic visioning and rapid process improvement workshops. 

You identify the project and its scope, then CRP Ally will prepare materials and exercises to engage participants in moving the project from vision to action. These events include a review of the applicable regulatory requirements governing  compliance considerations. This helps to align participants in their understanding of what is required and fosters an efficient, well-informed dialogue. You can be confident that the work completed, and decisions made, will  move your operations one step closer to your goals.

Are you 100% confident in your operational compliance with relevant laws and regulations? Have you identified concerning trends within monitoring reports? Has your site experienced a negative audit outcome? Or received an FDA 483 detailing observed  deviations from applicable regulations during an inspection? Or do you just want to take a proactive approach to securing confidence in your program’s compliance with applicable regulations? 

These events will engage your team in a strategic, systematic review of operations and relevant compliance considerations. The outcomes of which will provide an actionable roadmap to address the root cause of any issues. These intensive events utilize a structured approach to assessing compliance, building knowledge, and adequately developing preventative actions that do not create unnecessary workload burdens. The goal is to be compliant, not to create unnecessary operations, check steps, nor additional work.

The FDA has an important mission in protecting the public health by ensuring the safety, efficacy, and security of drugs, biologics, and medical devices. Inspections are a critical component to the drug and device development process. They are intended to verify the integrity of the research and verify compliance. CRP Ally takes the approach that  FDA inspections are  the “price of success,” to reassure the public trust when  new drugs, biologics, or devices are brought to market. 

These events are created to educate on, and prepare for, an FDA inspection. They provide foundational information from relevant sources including compliance program guidelines, CFR, and guidance documents within the context of real-world examples. Participants will be guided in the development of their site-specific risk assessment, inspection preparation plan, and inspection management strategy such that they feel confidently prepared when the FDA calls.