Quality System Remediation
Identifying issues. Executing a plan. Preventing recurrence.
Right-Sized Outsourced Staffing
In this highly regulated industry, managing the everyday manufacturing process can be difficult enough, and companies may not have the resources to properly address quality management system (QMS) issues.
We have a large network of quality and compliance experts with the knowledge and experience to identify the root cause of those issues and develop a plan to remediate them – and keep them from recurring.I
Whether you need one consultant to assist with determining the best approach, or several to work with your team on executing a remediation plan, we can tailor the solution to fit the unique needs of your project.
Whatever your need, we take pride in finding the right resource the first time.
We become an extension of your team and help guide you along the remediation pathway. Our experts help uncover the root cause of compliance issues, remediate them, and prevent recurrence so you are FDA ready.
Quality System Remediation Services with Scalable Flexibility
Whether you need help with determining the best approach to establishing a remediation plan, or you just need expert resources that can work with your team to execute the remediation activities, our right-sized solutions fit to your needs.
Remediation Services & Areas of Focus Include:
- Designing comprehensive remediation plans
- Root Cause Analysis
- Modernizing GMP manufacturing control
- Meeting with the FDA to resolve disputes
- Implementing corrective and preventive action (CAPA) programs-including development, execution, monitoring, and project management
- Complaint handling issues
- Supplier Quality Control & Management
- Supporting Enforcement of Remediation Actions
- Effective EU-MDR transition
- MDSAP Inspection Readiness
- In Vitro Diagnostic Regulations (IVDR)
- Data Integrity
- 21 CFR Part 830, ISO 13485, QSR
- 21 CFR part 210 and 211 Remediation
- Technical File and Design History File (DHF) Remediation
- Manufacturing and Facility Validation
- Part 11 and Computerized System Validation
- Quality Management System (QMS) SOP Development
Internal and supplier audit planning and execution
Risk Mitigation & Risk Management
We Help You Analyze and Craft a Response Plan To:
- FDA Form 483s
- Warning letters
- Consent Decrees
- Facility and supply chain audit reports
- cGMP deficiency letters
- Establishment inspection reports (EIRs)
- Other FDA regulatory and enforcement related actions
Engagement Options
Premier FDA Solutions offers multiple scalable outsourced staffing solutions based on your unique needs. With our sole focus on the Life Science industry, you can count on an efficient identification of these right-sized FDA experts.
Staff Augmentation & Recruitment
Take advantage of traditional outsourced staffing support for a specified duration with work performed on-site, remote, or a mix of both. Scale your team quickly by tapping into our extensive network of FDA experts with both FDA and industry quality/compliance work experience. You get scalable flexibility with resources that can quickly adapt to new responsibilities in a changing environment, such as company-critical remediation projects.
Functional Outsourcing
We provide you with an FTC (Full-Time Consultant) with the specific FDA experience you require for your task and who serves as an extension of your team, maximizing cost savings, flexibility and scalability. Our subject matter experts can follow your direction and use your systems, SOPs, and processes, and also serve like an internal resource that can be reallocated when priorities shift. By outsourcing individual functional tasks, you gain more freedom and are able to retain more control of your overall project.
CONTACT US
Contact Us Now for a Same Day Response and Get FDA Ready!
(262) 372-3039
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