Products by Compliance Insight Inc

According to FDA regulations, employees of pharmaceutical, medical device and biopharmaceutical companies are required by law to be trained in current Good Manufacturing Practices (GMP). Many have a made a commitment to their customers, to their clients and to themselves to make Quality a guiding...

The FDA conducts all establishment inspections based upon a systems approach. The FDA's Systemic Inspection Approach covers Quality, Facilities/Equipment, Materials, Production, Packaging/Labeling, and Laboratory. Compliance Insight conducts audits following this model so that our clients are...

Compliance Insight, Inc is pleased to introduce its biosafety testing consulting services for biologic pharmaceuticals and devices. Pharmaceutical and biotechnology companies may now benefit from a variety of new consultative services including: • sterility, mycoplasma, and viral testing for...

Strategic and Tactical Compliance Consulting • Regulatory Agency Issue Resolution (483’s, deficiency letters, …) • Evaluation of Commitments (vendors, outsourcing) • FDA Interface (Protocol review, deficiency response) • Vendor Qualification • GMP Expert Consultants (Consent Decrees)...

GMP training is required by federal regulations for all employees of food, dietary supplement, medical device and pharmaceutical companies (21 CFR Parts 11,111, 210, 211, 820). We provide on-site training services on a variety of topics including cGMP, QSR, investigations, auditing, Part 11...