Products by Compliance Insight Inc
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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... Read more »
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... Read more »
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... Read more »
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)... Read more »
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... Read more »
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