Ralph L. Dillon


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.

Making Regulatory Compliance a Core Process: Director and Officer Liability Exposure

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.

Creating Effective Biopharmaceutical QA/QC Organizations: Your People are the Key

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.

21 CFR Part 11: (Un)Expected Added Value

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.