Audits are a mainstay in the FDA-regulated industries. Virtually every pharmaceutical, medical device, diagnostic, and biotech company is subject to them at one time or another.
However, different audits exist depending on the regulations being evaluated. Some audits are designed to address Good Clinical Practices, whereas others are designed to address Good Laboratory Practices and Good Manufacturing Practices. Failing to understand what each audit addresses can lead to gaps in adherence to regulations, resulting in warning letters and other disciplinary actions.
As such, all FDA-regulated companies should understand the differences and similarities among these audits, and the guidelines and regulations they address.Continue Reading
Regulatory compliance training is important for personnel in a pharmaceutical company to remain current with appropriate regulations.
In preparation for announced and unannounced inspections by the FDA or other regulatory agencies, personnel should famialrize themselves with the latest national and international guidelines.
As such, pharmaceutical and medical device executives should understand what features are necessary for compliance training systems and how to maintain them.Continue Reading