Changes in a project vary in nature. Some are unexpected, such as weather delays or illness, while others are formally requested. Regardless of how they arise, each change must be carefully evaluated and either accepted or rejected. Once a change is approved, it initiates a structured change control process to help ensure the project stays […]
Regulations in pharmaceuticals, life sciences, and biotech demand unwavering compliance and a focus on continuous quality improvement. One of the most persistent challenges faced by Quality Assurance and Regulatory Affairs professionals is implementing a truly effective CAPA (Corrective and Preventive Action) program. While the concept of a CAPA program is widely recognized as essential for […]
When a defect or nonconformity arises in a product, it can disrupt supply chains, impact customer trust, and lead to significant operational delays. One of the key challenges businesses face is not just identifying these issues, but ensuring they are resolved at the root level and prevented from recurring. This is where a Corrective Action […]
Ensuring quality and compliance in the pharmaceutical industry is more challenging than ever. Companies face increasing regulatory scrutiny, complex global supply chains, and pressure to avoid quality issues that risk patient safety or delay production. A major weak point is the supplier network, where unqualified suppliers can cause violations, poor materials, and costly recalls. However, […]
The Food and Drug Administration (FDA) acts as the vigilant guardian of public health, issuing over 4,000 Form 483s in FY 2024, with the food area leading the way. For businesses in the pharmaceuticals, medical devices, food, and tobacco industries, the FDA’s regulatory reach is ever-present. A significant tool in their enforcement arsenal is the […]
Staying compliant with FDA regulations can be challenging, especially when inspection outcomes are complex and unclear. For regulated companies, understanding FDA inspection classifications is key to managing risk and staying audit-ready. We recognize that interpreting FDA inspection results and keeping up with shifting regulations can feel overwhelming for MedTech, pharmaceutical, and life sciences companies. Staying […]
For pharmaceutical, food, and medical device companies, staying compliant with FDA regulations is a constant challenge. Even minor oversights can result in serious consequences. One of the most severe outcomes is receiving a consent decree from the FDA, which can lead to production shutdowns, hefty fines, and long-term reputational harm. During this period, businesses may […]
Companies in the pharmaceutical, biotech, and food industries must ensure their products remain consistently safe, effective, and compliant with public health standards. Maintaining this level of quality presents a significant challenge, as it requires rigorous oversight of every stage in the manufacturing process. To meet these demands, manufacturers rely on Current Good Manufacturing Practices (cGMP). […]
FDA QSIT inspection readiness is often a major source of stress for companies in regulated industries, largely due to the high stakes and complex requirements involved. Many businesses are caught off guard not by what’s inspected but by how quickly the process begins the moment an FDA inspector walks through the door. From presenting credentials […]
Pre-Approval Inspections (PAIs) are high-stakes checkpoints in FDA-regulated industries that can significantly impact product approval and market entry. Many companies, regardless of size or past experience, often find themselves unprepared for the depth and rigor of a PAI. We understand that facing a pre-approval inspection FDA can feel daunting and stressful, especially given the complexity […]