Mock Inspection
As your partner in preparing your staff for the real scenario, we maintain alignment with the present, new, and most up to date regulations and industry standards that are applicable. Our team of expert consultants includes former FDA inspectors, MHRA Inspectors and GxP QA auditors, who conduct mock inspections to identify and address gaps, and suggest improvements. We make you aware of what inspectors are looking for during an actual inspection. Our consultants give structured reports in the same way as an inspection report from a regulatory agency.
With the help of our mock inspection strategies, we help you achieve the following outcomes:
- Evaluation of process controls, document controls, and records
- Verification of regulatory affairs and quality assurance
- Compliance with regulatory agency
- Identification of strong and weak points
- Motivation and preparedness for real-time inspection
Few Key Operational elements of our Mock inspection exercise include:
- Preparation for auditees (Sponsor location, Investigator Sites, Laboratories, Manufacturing sites, etc)
- Practical steps before, during and after Inspection
- Preparation of War Room and Front rooms
- Interview Training
