Pre-Approval Inspection (PAI) Readiness

Project Management

Project Management is critical to the success of every project. No example is better than the importance of Project Management for PAI Readiness. Inspection Readiness has a multitude of simultaneous and associated activities. These activities include assessments and evaluations, remediation and optimization, logistics planning and execution, training, mock inspections, etc. And, of course, there is the ever present need to conduct “business as usual” concurrently. The everyday work does not stop while a firm is getting "Inspection Ready". The Project Manager will initiate, plan, and monitor all readiness activities with quality, budget, and timeline in mind. Read Less

Inspection Readiness Evaluation

Our industry experts will audit and evaluate all aspects of your organization that are vital to a filing and commercialization - Quality Management Systems (QMS), Development,  Manufacturing, Laboratories etc.  Additionally, we can provide similar evaluations of your CROs, CMOs, and Testing Laboratories.  It is important to note that any organization listed in the filing is subject to inspection and should prepare. 

ProPharma will produce a report outlining observation criticality and recommendations to aid in remediation and optimization efforts for your firm. 

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Personalized Training

ProPharma can provide and execute various trainings to ensure Inspection Readiness. The entire organization will be trained on why PAIs occur and what to expect. Additionally, SMEs require and benefit from training on proper interviewing skills and responses to Inspectors’ questions. And finally, the Inspection Management Team’s training on roles, responsibilities, and their deliverables to ensure a smooth inspection experience for all.

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Remediation & Optimization

As an outcome of the Inspection Readiness Evaluation or other gap assessments, remediation or optimizations efforts with respect to policies, procedures, practices, documentation, facilities, etc. will likely be required. These activities can vary in size, criticality, or effort. Teaming with ProPharma for your firm’s remediation and optimization needs puts your firm closer to the finish line on your road to filing and Inspection Readiness. We have the experience and expertise to help guide you through the activities and ensure compliance and quality are maintained throughout. Read Less

Develop/Optimize an Inspection Program

ProPharma can create Standard Operating Procedures (SOPs) on how inspections are handled at your organization and/or vendor organization. We can implement request and response processes (paper-based or electronic). We can develop all of the tools necessary for a successful PAI. Alternatively, we can review your existing Inspection processes and optimize them as necessary.

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Inspection Assistance

Our highly experienced team members can support you in many areas during an Inspection. We have the experience to help you ensure your site is prepared to handle Inspectors and the nuances that come with hosting an Inspection. It’s vital to have support systems and support personnel trained, prepared, and tested to avoid hiccups during the Inspection. ProPharma’s experience cannot be overstated in this area, we have been through 100s of Inspections, and this is exemplified by our 100% success rate on PAI Readiness projects.

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Response Help

ProPharma is adept with Agency responses to observations, as well as Deviation and CAPA creation for remediation actions.

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Storyboarding

The most experienced and prepared organizations can still have "difficult to explain" or complex scenarios. The process of storyboarding allows the organization to align talking points on the complicated scenario. ProPharma has tools, templates, and training that are extremely useful for such scenarios.

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Mock Audit

ProPharma has helped many organizations plan and execute Mock Inspections with utilization of our former FDA investigators as well as our industry experts. Mock Inspections help ensure that the implementation, remediation, or optimization of processes has been a worthwhile effort as well as ensuring training on Inspection behavior has been successful.

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