Joseph F. Noferi, Esq.

Quality assurance units are interwoven throughout the biopharmaceutical enterprise and provide support to sustain operations. Most importantly, they must have the capacity and leadership to adapt to change.

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.

by Joseph Noferi, Pharmacia GS API Biopharma

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.

by Anurag S. Rathore, Joseph F. Noferi, and Edward R. Arling from Pharmacia Corporation, and Gail Sofer, Bioreliance; Peter Watler, Amgen, Inc.; and Rhona O'Leary, Genentech, Inc. The trick to process validation, these industry experts argue, is to understand that it is a process that stretches through the whole product life cycle. Some secrets of success: Take a team approach; focus on the timing of the various stages of validation; avoid some common mistakes; and build your documentation as you go.

by Joseph F. Noferi, Chimeric Therapies, Inc.

by Joseph F. Noferi, Edward R. Arling, and Ralph H. Dillon, Pharmacia GS API Biopharma, global supply, and Daniel E. Worden, Worden Enterprises FDA is no longer complacent, punishing noncompliant companies with puny fines, those small slaps at the financial bottom line. FDA?s thunder now includes multimillion dollar fines, permanent injunctions, and prison sentences for senior executives. Companies that emerge as winners in today?s environment are those that treat compliance and risk management with the same flawless planning and execution that they use for their business plans and their financial investments.

by Edward R. Arling, Ralph Dillon, and Joseph Noferi, Pharmacia GS API Biopharma Bringing a drug product to market requires that all parts of the manufacturing and validation puzzle comply with an increasing number of regulations. Managing the quality aspects for far-flung organizations can be a colossal assignment. A quality assurance unit may be the answer you need, along with finding capable, competent people and ensuring that they have the right communication tools.

by Joseph F. Noferi, Pharmacia GS API Biopharma and Daniel E. Worden If a process is out of control, an FDA inspector will find it, eventually. Companies that emerge as winners will be those that embrace compliance as a core business practice. Systems models provide strategic competitive advantage.

By Joseph F. Noferi, Esq., Ralph Dillon, and Daniel E. Worden, pp. 44-50. Implementing the ERES rule will do more than make your organization compliant with federal regulations. It will strengthen its intellectual property position for the information age.