Regulatory compliance is the foundation of success for any medical device and its manufacturer. Commercializing a medical product can quickly become even more expensive and challenging if your company and staff are not prepared to deal with complex FDA regulations. Much like a successful baseball team, preparation and practice is key for avoiding curveballs and unexpected stumbling blocks when it comes to FDA inspection. It’s so important to prepare for a possible regulatory inspection early in order to ensure that your staff is familiar with the FDA’s Quality System Inspection Technique (QSIT).
Start by working with an FDA regulatory compliance expert to conduct a mock inspection and audit designed to uncover any potential weak areas in your processes and documentation before you start to market your product. It is important to understanding the status of your quality system and how to anticipate the types of questions and requests you will receive from FDA inspectors.
The number of domestic and international inspections are increasing. Your contract manufacturers are also being assessed by the FDA. These inspections are not similar to ISO 13485 or supplier audits. There are several new FDA inspectors, many with industry experience and higher degrees. They come with a keen knowledge of how business’ work and how compliant systems are supposed to work. They will inevitably identify any holes in your quality system and quality records. A mock FDA Inspection will help plug those holes and help train your staff to manage the audit.
Pre-audit preparation should help your staff understand:
- What FDA inspectors look for inspection
- How to prepare for and manage an FDA audit
- Typical compliance issues and how to deal with them
- Inspection psychology – how to stay calm and focused during an FDA audit
To make the mock audit as thorough and effective as possible, it should include:
- A professional, objective, and in-depth post-audit assessment that analyzes your company’s state of readiness
- A post-audit action plan that details and prioritizes corrective actions necessary to reduce potential non-compliance weaknesses and vulnerability
- Follow-up inspection awareness training based on the mock audit’s outcome
An experienced FDA regulatory compliance consultant should also be able to provide you and your staff with any additional support, information, and guidance prior to a real FDA regulatory compliance audit to help ensure positive results.