Are You Ready For An FDA, MHRA Or EMA Inspection?

For Pharmaceutical and Medical Device Manufacturing, Zener Engineering Services Ltd (ZES) have worked closely with FDA, MHRA and EMA inspectors to ensure GxP Facilities, IT Infrastructure, Process Equipment and Computer Systems have reached the required standard for their first inspection and inspections beyond. Supported

Implementing quality systems, which comply with current regulatory requirements and cGxP, is an area of ZES expertise. ZES can provide support with the following areas of potential inspection observations, which have been a focus in recent inspections:

• Personnel
• Data Integrity
• Documentation
• Quality Control
• Quality Systems
• Sterility Assurance
• Production Systems
• Complaints and Recall
• Computerised Systems
• Qualification / Validation
• Premises and Equipment
• Good Engineering Practice
• Inspection Preparation and Training

ZES Experience Of Regulatory Inspections

ZES have worked closely with inspectors to help ensure inspection success. Whatever your FDA, MHRA or EMA inspection concerns, ZES are experts in helping clients achieve their goals and inspection success.

The ZES experienced FDA, MHRA or EMA inspection trainer can deliver bespoke Inspection Readiness Training, to help achieve a successful inspection outcome.