GlobalCompliancePanel

This presentation will explore FDA Corrective Action and Preventive Action findings in medical device manufacturer quality systems to determine FDA's concerns.

Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations.

In this NDA Approval Process training Webinar learn the guidance and regulations governing FDA’s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials.

If you handle any electronic patient information, don't miss this teleconference on compliance with the HIPAA security regulation.

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.

All regulations have strict requirements for electronic raw data and other e-records.

This presentation will review the Medical Device Reporting regulations and common violations leading to Warning Letter filings by FDA.

While not captured in most audit reports, one of the biggest mistakes an organization can make is to have insufficient self audits.

With today's movement into more and more serious controls over food safety and security,the liabilities associated with recalls and deaths are creating new approaches to determine and reduce the likelihood of risks associated with contaminated foods.

In this Clinical Trial Audits training learn the risk management and best practices of GCP audit by reviewing and analyzing recent GCP audit finding from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).