Criminal Web-based Seminars

Supply Chain Integrity and Security - Webinar By GlobalCompliancePanel The topic of supply chain integrity and security is relatively new in Pharma, having gained prominence in recent years for the reasons described above. Breach of security related to criminal activity is where the issues are most visible and enforcement activity is actively taking place around the globe. In parallel, if we are looking for sustainable, root cause solutions, we must also turn our  more...

What to Expect and How to Prepare for FDA Inspections - GlobalCompliancePanel As recent headlines demonstrate, non-compliance with US Food & Drug Administration US FDA laws and regulations could cost your firm millions. In addition to significant revenue losses, violative US FDA inspections may also lead to injunctions, consent decrees, warning letters, FDA 483 's Notice of Inspectional Observations, product non-approvals, import detentions, recalls, criminal  more...

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel .... * Controlled Substances Act: Briefly describes the criminal and civil actions that can be imposed on a hospital registration for failures to comply with the federal laws and DEA regulation pertaining to administering, dispensing and prescribing controlled substances in a hospital setting. * Due Diligence: This section provides numerous steps to be taken to prevent, detect, and  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...mounts of money and their executives have been prosecuted criminally. In addition to the regulatory and criminal consequences of off-label promotion, companies that promote off-label may be responsible for large plaintiffs' verdicts in products liability cases that arise from the off-label uses of their products. The pharmaceutical industry has been distributing reprints of scientific and  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ...have received multi-million dollar fines, with one facing criminal charges. Don't let you or your company be caught of guard by these major shifts in emphasis. Modify your internal audits to get 'in sync' with the FDA's shift in focus. Put in place a system to address areas of known deficiencies for FDA review. Areas Covered in the Session: * Key cGMP issues * Avoid complacency  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ...red in the Session: * Discuss the types of federal criminal and civil actions that can be imposed on a pharmacy pertaining to the purchase, sale, transfer, dispensing, destruction and theft or loss of Schedules II through V controlled substances. * Identify the responsibilities of DEA through their Diversion personnel to enforce federal laws and DEA regulations on the dispensing of  more...