Hospice Insights Podcast - Hospice Audit Updates: Hospices Fare Well in Federal Court
Compliance Tip of the Day: Assessing Internal Controls
Compliance Tip of the Day: COSO Objective 5 – Monitoring Activities
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
Compliance Tip of the Day: COSO Objective 3 – Control Activities
FCPA Compliance Report: Fraud Risk Management - Insights and Experiences with Peter Schablik
Hot Topics in International Trade - Let's Be Serious-Supply Chain Audits
Workplace ICE Raids Are Surging—Here’s How Employers Can Prepare - #WorkforceWednesday® - Employment Law This Week®
REFRESH Five Tax Traps for Business Lawyers Advising Nonprofit Organizations
Hospice Insights Podcast - Hospice Audit Updates: David Beats Goliath
Compliance Tip of the Day: Middle Managers as the Eyes and Ears of Compliance
Episode 365 -- Four Sanctions Cases Everyone Should Know
UPIC Audits
Compliance Tip of the Day: The role of Compliance in Auditing AI
California Employment News: Taking Advantage of the PAGA Reform – How Employers Can Lower Their Risk of PAGA Liability
Auditing Your Hotline and Case Management System
Hospice Insights Podcast - Controlling the Narrative: A New Tactic for Auditors and ALJs
Improving Your Code of Conduct
Now Is the Time to Conduct I-9 Audits: What's the Tea in L&E?
Preparing for — and Surviving — an OFCCP Audit
The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more
Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not the final step. Before selling your products in most states, you must navigate state licensing...more
Since the fall 2023, the United States has been facing a massive recall of apple cinnamon fruit purees (like apple sauce) due to the presence of elevated levels of lead which caused the product to be considered adulterated...more
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program with a focus on the topics and issues that affect research compliance professionals. Our faculty of experienced...more
Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more
Well, Easter has come, which can only mean that it is time for our spring holiday compliance special! In honor of the season, here are some interesting facts about Beatrix Potter, the author of The Tale of Peter Rabbit: ...more
Arguing that the National Science Foundation (NSF) was “intricately involved” when it made a $1.125 million fixed amount subaward, Oklahoma University (OU) objected to a recent finding by auditors for the NSF Office of...more
When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more
In the world of FDA-regulated companies, compliance with regulatory requirements is not just a matter of paperwork. It is a critical aspect that can significantly impact mergers and acquisitions (M&A) and the overall success...more
Staying up-to-date with fraud enforcement trends and recent cases and settlements can sometimes be viewed as a “Glass Half Empty” perspective, focusing on negative aspects of the industry and the perceived threat of...more
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day intensive training program designed to help attendees increase their ability to manage effective research compliance programs. Our faculty of experts...more
As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more
The Bioresearch Monitoring Program (BIMO), run by the U.S. Food and Drug Administration (FDA), oversees the conduct of on-site inspections and data audits of FDA-regulated research in support of new product development and...more
Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more
A few weeks ago, AGG’s Food and Drug Practice Team launched its podcast series to discuss topics affecting the FDA-regulated industry. The series, called “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues,”...more
Report on Research Compliance 17, no. 7 (July 2020) - NIH has opened its “initial data set and tools” in its All of Us research program to investigators under a new beta model that does not allow downloading of...more