• We can perform a mock FDA audit of your operations to determine compliance to the FDA QSR (Quality System Regulation) /cGMP (Current Good Manufacturing Practices).
• The audit would be performed in similar manner to a FDA audit and will be performed by former US FDA field investigators.
• These mock audits serve two purposes: testing your quality system and providing recommendations for corrective actions.
• We provide FDA QSR/cGMP employee training and internal auditor training.
• Our in-house training sessions include all aspects of FDA regulatory and quality system requirements including: cGMP compliance, Design Review, Process Validation, Sterilization Validation, FDA strategic Planning, Dealing with FDA inspections and how to prepare replies to FDA 483 and Warning Letters.
We can put together customized training programs that are geared to your products and operations.
• Risk analysis is required for medical devices by most of the world regulatory authorities. The application of risk analysis spans the entire life cycle of the device, starting from the design and development phase to post-marketing design changes.
• Risk analysis is being increasingly called out by the regulators for integration into the entire quality system. Examples of this include applying risk analysis during complaint investigations and Corrective and Preventive Action (CAPA) implementations.