Are You Ready for the FDA?
Free FDA GMP Checklist
Highlight any compliance gaps in your quality management system with a comprehensive FDA GMP Checklist...
Try our free FDA GMP Checklist.
To be ready for the FDA a company needs to identify compliance gaps, implement solutions that work, and present material to FDA effectively.
FDA inspections are inconsistent and unpredictable. Despite these uncertainties, the consequences of regulatory delays or difficulties can be devastating. Internal audits need to be impartial and thorough. Documented procedures must reflect actual business practices. References must be industry-standard and fair. Solutions need to be specific, measurable, achievable, realistic and timely... CSCA can help your company save time and avoid costly implementation errors. Our
FDA Compliance Seminars
will guide you step-by-step; cGMP training information covered: * How to know the likelihood of an FDA inspection and what to expect. * How to respond to 483's and Warning Letters. * Product recalls and medical device reporting requirements. * FDA requirements for importing and exporting devices. * How to get the most out of our FDA GMP Checklist.
It is worth this effort! The U.S. Food and Drug Administration's (FDA) revised Good Manufacturing Practices (GMP) have been issued for all organizations manufacturing medical devices, food and beverages, pharmaceuticals, and tissue and bone products. Current Good Manufacturing Practices (cGMP's) must be implemented by all organizations selling these products within the US. The revised version of GMP is based on ISO 9001.
CSCA can assist your firm in complying with these standards by providing the following services: * Inspection Prep Strategy * Internal and Supplier Audits * On-site training in FDA requirements * Quality system procedure development and documentation * Quality system compliance audits * Mock FDA inspections and gap analysis * Plans and outlines to improve compliance
Which Organizations Should Be Involved?
Organizations throughout the world who manufacture and sell medical devices, food and beverages, pharmaceuticals, and tissue and boneproducts in the United States must comply with the FDA's cGMP'sstandards.
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