ISO 13485

20 04, 2022

Understanding FDA Alignment of ISO 13485 with Quality System Regulation

By |2022-04-20T07:34:08+00:00April 20th, 2022|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]

17 03, 2022

Remote Quality Audits for Regulated Companies Come of Age

By |2022-03-17T07:36:26+00:00March 17th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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

By |2022-02-24T08:54:20+00:00February 24th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Technology, Politics, Climate, and the Coronavirus will Drive Maturation of Inte [...]

9 02, 2022

7 Benefits of Quality Risk Management in the EQMS

By |2022-02-12T22:55:03+00:00February 9th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Regulators and standards organizations are increasingly requiring manufacturers [...]

Go to Top