No Password Required: From Heavy Metal to the Front Lines of Cyber Innovation
Data Driven Compliance: The Failure to Prevent Fraud Offense: Insights for US General Counsels with Mike DeBernardis
Operationalizing Trust at Scale: Evolving Compliance: Neta Meidav on the Diligent Acquisition and AI Integration
Great Woman in Compliance: Building Strategic and Effective Risk Assessments
Innovation in Compliance: Gaurav Kapoor on Risk Management and the Role of AI in GRC
Compliance Tip of the Day: Finance Models for Compliance
Compliance Tip of the Day: Design - Centric Internal Controls
Compliance Tip of the Day: Why Engage in Pre-acquisition Due Diligence
Compliance Tip of the Day: Bringing Predictive Analytics into Your Compliance Regime
Compliance into the Weeds: Sanctions Compliance Failures: Lessons from Harman International and Interactive Brokers
Adventures in Compliance: The Novels – The Hound of the Baskervilles, Introduction and Compliance Lessons Learned
Compliance Tip of the Day: Assessing Internal Controls
Compliance Tip of the Day: COSO Objective 5 – Monitoring Activities
Compliance Tip of the Day: COSO Objective 2 - Risk Assessment
FCPA Compliance Report: Fraud Risk Management - Insights and Experiences with Peter Schablik
#Risk New York Speaker Series – Inside Behavioral Insights: Tom Hardin on Compliance at #RiskNYC
Compliance Tip of the Day: COSO Framework
#Risk New York Speaker Series: Exploring AI Risks in Compliance with Gwen Hassan
Healthcare Enterprise Risk Management
Compliance Tip of the Day: What is a Gap Analysis
In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more
Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....more
In the December Public Company Watch, we cover key issues impacting public companies, including a preview of the SEC’s latest regulatory agenda, an update regarding the Fifth Circuit vacating the SEC’s share repurchase rules,...more
The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices....more
On 13 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published four final guidance documents on the 510(k) program. ...more