Apr 12, 2012
As industry has been looking to reduce costs, improve efficiency, the FDA has begun to more closely scrutinize the industry’s effort to make certain that the above mentioned controls are in place. In this effort the FDA is focusing on supplier
Mar 23, 2012
The topic aims to address and compare the requirements of SOX against the Dodd-Frank legislation and contrast how they differ clearly in purpose and objectives. The perception is that they are similar and overlap whereas on the contrary they
Mar 22, 2012
Under regulations now being finalized, Business Associates of HIPAA Covered Entities will be covered directly under the HIPAA regulations, and will have to create HIPAA Privacy, Security, and Breach Notification compliance programs. In addition,
Mar 22, 2012
Learn about the next phase of the evolution of risk management and how auditors are playing a starring role. Hear about the varying roles internal audit plays in successful ERM programs.
Mar 22, 2012
A letter of credit is one method of payment used in international trade transactions. The Uniform Customs and Practices (UCP 600) are the current internationally recognized set of rules created by the International Chamber of Commerce (ICC)
Mar 22, 2012
The current set of international trade terms are the Incoterms® 2010 rules created by the International Chamber of Commerce which define responsibilities, risks, and costs of the seller and buyer for delivery of goods under sales contracts.
Feb 28, 2012
As part of their improvement activities, companies need effective Corrective Action and Preventive Action (CAPA) systems. To implement an effective system you must understand the requirements, including the difference between corrective action
Feb 28, 2012
With the increasing frequency of real-time FDA audits and complexity of Investigational Medicinal Products (IMP’s), the wise are paying more attention to including a full range of lab tests to insure IMP safety. Which lab values outside of the
Jan 24, 2012
It is well known that document control is a critical requirement for FDA-regulated companies. However, document control can be a time- and paper-consuming process, in which even the simplest of changes requires an inordinate amount of time spent
Jan 24, 2012
Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, not following the procedures to make the device as established in the DMR,