FDA Compliance Remediation

FDA Compliance is complex. Our FDA Compliance Remediation program can help you fix that.


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It’s a known fact that an FDA 483 and Warning Letter often only address a small portion of the true deficiencies in the quality system. QualityHub can help determine the actual depth and breadth of the quality system deficiencies using our FDA Compliance Remediation program. The program includes preforming baseline audits, and crafting an FDA Compliance Plan (a remediation program) to bring the quality system areas up to the expected level of compliance to FDA requirements and/or best industry practices. QualityHub provides the resources to be successful in this effort.

Most FDA Compliance Plans require Remediation. Remediation includes rebuilding of the Quality System, and also re-doing and/or repairing work already done.

 

 


 

 

Strategic Consultation on Quality Systems

Develop Strategy & CMP – The Compliance Master Plan is the blueprint for driving sustainability of the organization in terms of compliance. QualityHub will assist with the design and implementation of a holistic and global Compliance strategy that includes the QMS architecture, leadership, governance, knowledge transfer, and best practices. Many companies who have chosen QualityHub to assist on their Regulatory Compliance Initiative have been able to leverage our name in order to gain FDA’s confidence.

 


 

 

Strategic Project Oversight

Project Management is essential. QualityHub’s strategic project oversight team will establish an efficient and effective project management office (PMO) to plan, track, and monitor complex initiatives that typically include multiple projects – each with unique deliverables, budgets, and timelines critical to establishing compliance. The PMO will develop Scorecards and other key deliverable for executive management.

 


 

 

Develop and Implement Quality Systems

Using a team approach, QualityHub will mobilize the necessary Subject Matter Experts (SMEs) who will help the departments establish systems that meet the FDA requirements. These SMEs can help create a strong and sustainable quality system, or in some cases, they can help institute best practices. Knowing our clients own the quality systems when we leave, we carefully blend business goals, compliance strategy, and expertise with “day to day” tactical execution to make the systems effective, functional and pragmatic.

 


 

 

Project Leadership and Lifelines

Successful compliance strategies require buy-in from Senior Management as well as strong Project Leadership. QualityHub has a unique approach to help you be successful. Using our QualityHub Executive Level* consulting, we meet with Senior Executives to help them understand the importance of quality and compliance strategies and obtain buy-in. In some cases we educate Senior Executives – when they are not familiar with FDA expectations and FDA Compliance processes. Next we work with other key executives to educate and gain further buy-in.

 


 

 

FDA Response Support and Regulatory Agency Interaction

Following an FDA Inspection, the need to promptly prepare a compelling response to FDA is crucial. At QualityHub we have former FDA Office of Compliance Directors, Associate Directors, Branch Chiefs and other ex-FDA personnel with first-hand experience in crafting and reviewing the adequacy of responses.

Often situations arise where the best course of action is a one-on-one meeting with FDA and/or other Regulatory bodies. QualityHub will partner with you and your team during meetings with FDA at their District Offices or at Headquarters, or at any other Regulatory body location worldwide.

 


 

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