This clinical trial audit training will explain how to identify gaps and risks when preparing for regulatory inspections of sponsor monitoring programs by understanding the components of a clinical trial quality monitoring system.

This webinar will provide an in-depth understanding of anti-kick back and stark laws, and discuss how marketing activities can trigger either or both. It will show how to implement mandatory internal controls to reduce exposure to risks.

This webinar will provide advanced training in planning, executing, and reporting HR audits. Critical HR audit issues will be review including developing an HR audit plan, identifying audit stakeholders, critical employment practice areas, and analyzing key performance and risk indicators.

This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use.

This training on FDA’s regulation of cosmetic labeling will detail the labeling requirements for manufacturers, packers and labelers of cosmetic products in the United States. It will also cover general labeling and ingredient-related limitations that federal laws and regulations place on cosmetic products.

This training on data security will provide the tools to design and implement effective IT control structures and audit programs to help comply with the current data privacy and confidentiality regulations.

This training on fraud awareness program will discuss recent history and profile of fraud cases and will help attendees understand specific processes and techniques needed to be effective when providing assistance on fraud issues.

This webinar on Medical Device Reporting (MDR) will cover FDA requirements for importers, manufacturers and hospitals to report medical device adverse events. It will discuss current policies and guidances for Medical Device Reporting and provide update on upcoming regulations.

This training will teach you how to prepare for a medical staff professional review adverse action hearing, including what steps are necessary to afford the respondent practitioner due process.

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.