Risk Management in ISO 13485
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue i [...]
26
07, 2023
17
03, 2022
Remote Quality Audits for Regulated Companies Come of Age
This article is part one of a two-part series focused on GMP quality audit manag [...]
24
02, 2022
Trend Watch: 2022 and Beyond Will see Maturation of Internal Control Programs
Technology, Politics, Climate, and the Coronavirus will Drive Maturation of Inte [...]
9
02, 2022
7 Benefits of Quality Risk Management in the EQMS
Regulators and standards organizations are increasingly requiring manufacturers [...]
4
01, 2022
Quality Risk Management: A Proven 4-Step Process
There’s no question that quality risk management is becoming an indispensable to [...]
9
12, 2021
3 Essential Document Control Best Practices for Combination Products
Combination products (CPs) have revolutionized drug delivery and patient care, b [...]
13
06, 2017
Medical Device Manufacturers Warned For CAPA Non-Compliance
Three recent warning letters from the Center for Device and Radiological Health [...]
