Compliance system

Schedule Y of the Drugs and Cosmetics Rules sets up the requirements for clinical trials, and that of Schedule M for GMP compliance system. 

The purpose of this paper is to describe the GLP compliance system developed for the Residue Chemistry Field Trials Program at ICI Americas Inc. This program covers crop residue and environmental fate studies. 

The firm could have avoided receiving this citation by ensuring the adequacy of two critical compliance systems ... 

This is an example of a rating system for a biologies or pharmaceutical manufacturing operation. The comprehensive assessment should cover all critical compliance systems (process validation, personnel training, change management system, etc.) and determine whether or not they meet FDA expectations and current industry standards. 

This database includes information on facilities/sites which are regulated by EPA programs. It provides regulatory information from numerous EPA information systems, including Aerometric Information Retrieval System (AIRS), CERCLIS, Permit Compliance System, RCRIS, and others. 

The EPA maintains many databases of environmental regulatory data. Among these is the Permit Compliance System (PCS) database http //www.epa.gov/enviro/html/ pcs/pcs query java.html. This database provides many of the details governing a facility s wastewater dischaiges. Specific limitations typically depend on the classification and flow of the stream to which a facility is discharging. SiuTace waters are classified as to their intended use (recreation, water supply, fishing, etc.), and then the relevant conditions to support those uses must be maintained. Wschatge limitations are then set so that pollution will not exce these criteria. 

Permanent racks, 1521, 1522 Permit Compliance System (PCS) database, 596 Perpetuities, 2350-2351 Personality, and workplace accidents, 1160 Personalization of products, 267, 268 Personalized Web Assistant, 269 Personal mastery, 999 Personal quality, 1796 Personnel. See also Employees assignment of ... 

The concept of looking across specific laws and regulations to the underlying operations of the business is the preferable way to structure a compliance system. Because TSCA is not specific to any one environmental medium, a thorough and well-designed TSCA audit should look at all the environmental media. For example, the EPA can use TSCA to regulate the release to water of a specific chemical, or its presence as breathable particles in the workplace, or its method of disposal. In those circumstances an audit should investigate all of the pertinent media. 

If systemic areas that need improvement are discovered through auditing or a compHance system, consider developing goals around the improvements of those areas. Streamlining the TSCA compliance system in measurable ways could be an appropriate goal for a more mature system. 

Community outreach is more a feature of an environmental management system than of a traditional compliance system. To the extent that operations could potentially impact the company s surrounding community from a TSCA... 

All5(e) Consent Orders, SNURs, and Significant New Use Notifications (SNUNs) relating to the acquired business. The buyer will need to establish or continue a compliance system to meet the order s or rule s... 

Workshop on last slides are to evaluate the compliance system in place— small breakout groups with presentations to entire group will facilitate enhancements to the system as needed consult Chapter 13, Compliance, "TSCA Requirements Matrix by Function" to select processes appropriate to the group being trained... 

Perhaps you are extremely fluent in the Federal Motor Carrier Safety Regulations (FMCSRs), yet your organization continues to operate in violation because your safety and compliance systems are not meeting your expectations. 

The major components of a compliance system are regular inspections, reporting, incident investigation, follow-up, enforcement, and recognition and reward. The system should emphasize fact finding, not fault finding. That applies to all the safety and security programs and policies described in Chapter 3. Initiation and maintenance of an effective compliance system are important to ... 

Corporate risk and compliance systems fully reviewed and continue to be improved Regulatory messages sustained Self-regulation fully operational... 

Project Basin level compliance system and cariying capacity study... 

---