FDA Inspections. com is an innovative and premier portal for FDA informational and educational services. It contains high quality services, social-networking, training courses, products and tools specifically designed for increasing your compliance to FDA laws and regulations, deepening your understanding of FDA inspections, helping in the preparation of inspections, assisting in the facilitation of different types of FDA inspections and in resolving issues from FDA inspections.
FDA Inspections.com was founded by a former award-winning US FDA Consumer Safety Officer with significant experience in domestic and international inspections. Supported and developed by former FDA and having highly experienced Industry Contributors, it provides in-depth knowledge and insight into FDA inspections. It was designed to assist domestic and international FDA regulated pharmaceutical, medical device, in-vitro diagnostic,blood banks, computerized systems, food and beverage, clinical trials, cosmetics and dietary supplements companies in preparing for, facilitating and remediating all types of FDA inspections and FDA Inspectional Issues. These include PAI Inspections, QSIT Inspections, GMP Inspections, GLP Inspections, Foreign Inspections, GWQAP Inspections, Regulatory Inspections, Criminal Inspections, Surveillance Inspections, Compliance Inspections
Issues addressed include Preparation and Planning for Inspections, Training, Audits and Mock Inspections, Regulatory Basis for Inspections, FDA History, FDA Case Law, FDA Forms and Publications, FDA Offices and Organization, FDA Enforcement Tools, Laws and Regulations Affecting Inspections, Industry Standards Affecting Inspections, Inspection Techniques, Inspection Review of Documentation, Hosting FDA Inspections, FDA Inspectional Tools, FDA Reporting, FDA-483, Notice of Inspections, FDA Warning Letters, FDA Enforcement Activities, FDA Seizures, FDA Import Detents, FDA Cooperation with other Agencies, FDA Inspection of Foreign Facilities, FDA Compliance Meetings, FDA and DOJ Criminal Investigations and Issues, FDA New Initiatives, FDA Facilitation of Inspections, Required FDA Documenation, FDA Special Inspectional Issues: Management Responsibilities, Management Reviews, Computer Systems, Documentation Systems, Quality Systems, Corrective and Preventative Actions CAPA, Risk Management, Submission Reviews, Registrations and Licenses, Validation, Research and Development, Change Control, Product Development and Design Controls, Quality Records, Quality Control and Laboratories, Complaint Handling, Manufacturing and Distribution, Part 11, Electronic Records and Electronic Signatures, Recalls and Safety Alerts, Facilities, Design and Qualification, cGMPs, QSR, GLP, Sampling, Photographs, Affidavits, Supplier Qualification, Internal, External and Vendor Audits, etc. ,
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