The FDA Process Validation training highlights opportunities in enhancing comprehension of constant process verification aligned with lifecycle concepts. It addresses early R&D phases through ...

The FDA recently issued draft guidances for the use of AI in medical devices, drugs, and biologics. The guidances emphasize the need for comprehensive AI policies addressing risk evaluation, data ...

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 ...

As the FDA's May 2026 guidance on AI in drug manufacturing takes effect and a new pilot program offers sponsors extra CMC-focused meetings, the pressure is on to modernize regulatory workflows.

On March 18 th, the FDA published draft guidance on validating new approach methodologies (NAMs), including complex in vitro models (CIVMs). For a field long operating without a clear regulatory ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

For manufacturers, medical device companies, and laboratories that use the commercial diagnostic tests they produce, ...