The TCG team, consisting of former FDA inspectors and industry experts, has the capabilities and expertise to perform a wide array of audits and assessments; including: Data Integrity focused audits, GMP, GCP, GLP, BIMO, OTC, 3rd party and supplier audits of (CMOs, CTOs, CROs), mock FDA inspections / PAI readiness, due diligence – mergers/acquisitions, and other specific quality system topics.
Whether you are looking for an auditor with a specific expertise to join your existing audit team or you are seeking someone to conduct an audit on your behalf TCG can provide the right resource.
Taking a deep dive to assess the accuracy and reliability of a company's data is a core strength for TCG. We utilizes a cadre of associates who are skilled in assessing systems and processes for data integrity vulnerabilities. Our assessors were end users of many laboratory and manufacturing systems and are trained in the detection of data integrity gaps. TCG auditors are well versed in the latest software; including Data Acquisition systems, both in the Laboratory and Manufacturing environments. Our assessments will identify system weaknesses and provide solutions to address these deficiencies with simple yet compliant recommendations.
Mock Inspection
Mock Inspections are typically conducted by former FDA inspectors. These team members bring a real-life experience to what the company can expect during a FDA inspection. This experience has been proven to be invaluable to companies that have never been inspected and/or are planning for an upcoming inspection. It helps personnel understand the inspection process, what inspectors look for, and techniques they utilize during the inspection. It provides a firsthand experience of what the regulatory inspection will be like and helps personnel be prepared with responding to an inspectors’ questions. As a result, the mock inspection identifies areas that need to be bolstered prior to a regulatory inspection.
Inspection Readiness
TCG experts can also help companies prepare for inspections of regulatory authorities by providing inspection readiness/preparation. We can teach companies how to manage inspections including; what documentation should be readily available, how to prepare Subject Matter Experts (SMEs), how to take notes and record events. We often combine PAI Inspection Readiness training with mock audits.