Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...

The author describes why statistical significance would impose an unreasonable burden on manufacturers. Validation has been practiced within the global healthcare industry since the early 1970s. While ...

Overview: Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that ...

Incorporating Q8, Q9, Q10 into good manufacturing practices (GMP), guidance on process validation, health based exposure limits covering cleaning validation and computerized system validation are the ...

This course provides candidates with practical tools for validation including, qualification, process validation and analytical method validation. Incorporating facility/equipment qualification, ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

VP and CISO for Mandiant, helping guide the company's product and solutions strategy and host of the Cyber Security Effectiveness Podcast. Understanding the effectiveness of your company's security ...