Tracy Harding, CPA, was on his way to work and looking forward to completing an audit he was working on. But on the way in, he heard a news report that changed the objective of his day. A local ...

Environmental contamination control is a crucial aspect of sterile pharmaceutical manufacturing, and risk management is needed to guarantee that the necessary control procedures are in place. The risk ...

Early efforts to prevent machine-related injuries were focused on the development of engineering specification standards. These specification standards laid the foundation for further requirements ...

Elemental impurity risk management can help biomanufacturers to maintain regulatory alignment and ensure patient safety.

The widespread use of information technology (IT) can introduce various risks that affect financial reporting and the audit process. To assist auditors in identifying and addressing these risks, the ...

Airline safety comparisons often focus on outcomes, while regulators and operators assess safety performance through layered ...

"Wallace, if we lock out this machine every time we have a pill jam, we will never make any product!" This was the testy response I received from a production manager while performing a lockout audit ...

GOJO, a global producer and marketer of skin health and hygiene solutions and the inventors of PURELL, offers a free, downloadable and adaptable sample infection control risk assessment form for ...