FDA Inspection Audit Support
Inspection Readiness. Audit and preparedness. Product, systems, and facility qualification and validation.
GxP Audit Support
Our team of FDA experts understands the importance of a successful inspection, and the role that a detailed audit can play in your inspection outcome.
We know the importance of fostering a culture of quality and establishing a proactive quality management system.
Whether you are in need of a comprehensive corporate quality management system audit or a completely focused site audit, our thorough, highly-effective, attentive and scalable FDA audit support services help you reduce FDA inspection risks while you continue to focus on your business objectives.
Validation / Qualification Activities:
- Evaluation of products, equipment, and facilities
- Qualification of policies, procedures, protocols, and master plans
- Computer Systems Validation and 21CFR Part 11 Compliance
- Validation of:
- Manufacturing, labelling, and packaging processes
- Cleaning and sterilization systems and processes
Other Inspection Related Activities:
- Internal audits or GAP assessments of the Quality Management System
- Vendor and Supplier audits
- GDP audits
- Due Diligence
CONTACT US
Contact Us Now for a Same Day Response and Get FDA Yourself Ready!
Give us a call
(262) 372-3039
(262) 372-3039
Email Us
info@premierfda.com
info@premierfda.com