FDA Compliance Remediation
FDA Compliance is complex. Our FDA Compliance Remediation program can help you fix that.
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.
Examples of the resources provided are Senior Consultants who can serve as Project Leads, Subject Matter Experts (SMEs), Senior Advisors and Trainers. We also can back-fill your professional staff while those individuals are tasked with remediation work.
The efforts to remediate records and work already done is a type of remediation that QualityHub can also help implement and execute. These activities often involve re-doing work in the areas of Complaints, MDR decisions, CAPAs, Process Validations and other areas. QualityHub provides the resources to create the needed strategies, supervise and manage the remediation, and also the staff who can execute the work. Our program provides the needed support, either as consulting professionals or as temporary staff augmentation. In addition to the name recognition of QualityHub, the advantage of using QualityHub for remediation is the one-stop shopping aspect of getting the audits, the solution, and the remediation all done under one flag, without the risk of conflicts and confusion that often happen when multiple consulting companies work on the same remediation project.
Should your company be in need of a Regulatory Compliance initiative, we recommend that the following components be included. We are equipped to resource each of these areas:
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.
In parallel, our Project Leaders will bring their experience managing compliance strategies at other companies. Some of this experience was gained during projects involving FDA-483s, Warning Letters, and Consent Decrees. The boots-on-the-ground Project Lead works with site management, the PMO, the QualityHub SMEs, our Senior and Associate Consultants, and company personnel to ensure we are working from a game plan, mitigate any risks, make any necessary course corrections, and verify that the work being performed is effective. The Project Lead will brief Senior Management (often using a Steering Committee) as needed throughout the project.
As needs arise during the project, Senior Management and the Project Lead can ask for a life-line from QualityHub by tapping into the “Hub”. With our vast pool of experts, QualityHub can collaborate with Expert or Senior Executive level consultants on short notice (in most cases these are specialists) to assist with the project. Additionally, the project team can work with the Executive Consultants at QualityHub to help calibrate and ensure the leadership aspect of the project is going smoothly.
*Executive Level Consultants are ex-FDA and ex-industry executives with 20+ years experience.
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.
Our extensive experience with FDA and Regulatory bodies can be leveraged to help you prepare for meetings, craft the right message, and answer FDA’s questions, as necessary. We provide support in the following areas:
- Assisting with Strategies
- Communicating with Regulatory agencies
- Communication and support for 483s, Recalls, Warning Letters, and Consent Decrees
- Assisting with FDA negotiations and appeals
- Providing verification to FDA and Regulatory bodies on client progress
- Acting as a FDA liaison for international and domestic clients
- Preparing FDA meeting requests and requisite briefing packages
- Performing “rehearsals” for FDA meetings using former FDA Compliance Managers
- Preparation and delivery of presentations to FDA and/or other Regulatory bodies
- Performing on-site regulatory assistance, and training related to Regulatory Interactions
- Provide guidance on the latest regulatory issues and requirements
We are here to help.