Joseph F. Noferi, Esq.

Articles

Information Age Audits

Understanding the reach of 21 CFR Part 11 is the first step to assessing its impact. To protect your company, you need integrated quality audit solutions to evaluate the underlying validation of your electronic data.

Guest Editorial: At the Governance Crossroad

by Joseph Noferi, Pharmacia GS API Biopharma

You Have Failed . . . A Case Study in Warning Letter Remediation

by Joseph Noferi, Edward R. Arling, Ralph L. Dillon, and Mikael Blomqvist, Pharmacia An FDA Warning Letter can be a business disaster. This case study tracks a company from receipt of an FD 483 ? that did not find contamination, but only the potential for contamination ? to 18 months later when the facility received a clean bill of health. What it did to get there ? and what it learned ? may keep your site from losing its operating freedom.