Auditee: Properly handling and documenting employee training records is essential to ensure that personnel are adequately trained, competent, and compliant with FDA regulations. Here’s a walkthrough of our process for…
Auditee: Conducting internal audits is a critical aspect of maintaining a robust quality management system and ensuring compliance with FDA regulations. Here’s a description of our process for conducting internal…
Auditee: Ensuring that our products meet FDA requirements for identity, strength, quality, and purity is a fundamental aspect of our operations. Here’s an overview of how we ensure compliance with…
Auditee: Validating analytical methods used in quality control is crucial to ensure the accuracy, reliability, and consistency of test results. Here’s an explanation of our process for validating analytical methods:…
Corrective and Preventive Action (CAPA) processes are essential for addressing issues, preventing recurrence, and improving our quality management system. Here are examples of our CAPA processes and how they have…
Auditee: Effective communication with regulatory authorities, including the FDA, during audits or inspections is crucial to demonstrate transparency, cooperation, and compliance. Here are examples of how we communicate with regulatory…