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Stark: What It Is And How To Comply
The session will provide an overview of the physician's anti-referral law (known as Stark II) and its available exceptions. It will also show how violation of Stark II can raise False Claims Act concerns, and it will provide an assessment of enforcement activities, showing how participants may be at risk. In addition, the session will review recent cases and show how they potentially impact participants.Cla..
Effective GxP Instructions Writing
Standard Operating Procedures (SOPs) are the backbone of Good Practice (GxP) compliance in the pharmaceutical, biotechnology, and medical device industries. Yet, despite the critical role SOPs play in daily operations, companies continue to invest significant time and money into writing, maintaining, and training employees on SOPs, without offering meaningful training on how to actually write them effective..
The five qualities every successful leader must develop
IntroductionLeadership is more than just making decisions—it’s about inspiring others, managing uncertainty, and driving ethical, sustainable success. While some leaders excel, others struggle because they lack critical qualities that define success.This session will break down the five leadership qualities that every professional must develop to effectively lead teams, manage risks, and drive long-term bus..
From Chaos to Clarity: Addressing Bottlenecks in Communication and Collaboration
In today’s fast-paced world, poor communication and collaboration bottlenecks can derail projects, damage relationships, and drain energy. This session explores the root causes of these bottlenecks and provides actionable techniques to create clarity, improve workflows, and strengthen team dynamics. Whether you’re working in an organization or managing your own business, these tools will help you cut throug..
How to create an effective and GMP compliant Training Program and reduce Training related human errors
Training programs have evolved. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though the training is considered the “vaccine for mistakes,” training is not responsible for most human error deviations. To ensure training programs are effective and can be ruled out as a root cause for human error deviations, we will discuss the ..
From In-House HR Professional to Solo HR Entrepreneur: 5 Key Lessons for Success from a Seasoned Freelancer
Starting your own business is exciting, especially if you’ve been working for (large) organizations for a long time. Finally, you’re fully in charge of how you organize your day, what clients you work with, etc. But what some people forget, or don’t consider enough, is the other side of working for yourself. How do you make sure you get paid enough, for example? What are the taxes going to be like? Where wi..
Drug Pricing Policies
The price of medicines is one of the factors that can limit the affordability of medicines to the population. So there are many drug pricing policies that could be implemented by the regulatory authorities based on the level of control they intend to implement on drug prices in the national market to assure that drugs are available in the market at fair prices. The national regulatory authority ma..
Best Practices In Evaluation And Hiring
Best Practices in Evaluation and Hiring: What the Research Shows and What Actually WorksHiring is one of the most important responsibilities of any leader or HR professional. Done well, it builds strong teams, improves performance, and sets people up for success. Done poorly, it leads to turnover, disengagement, and organizational risk. Yet despite how high the stakes are, hiring practices often vary widely..
How to Transform Existing Wellbeing Practices. From Burning out to Flourishing
Let’s cut through the noise: most employee wellbeing programs are failing, and the data show this. Burnout is rising. Engagement is falling. Stress-related absenteeism is surging. And despite companies spending billions on wellness solutions, leaders are still asking, “Why isn’t any of this working?”Here’s why: Most well-being initiatives are reactive. They’re built to treat symptoms, not solve ro..
The Best Offense Is When The Injury Is Reported, Including The Best Follow-Up, Thereby Reducing Or Eliminating Citations
When an employee injury occurs, most HR professionals and supervisors assume that simply completing the claim form from their workers’ compensation carrier is enough. Unfortunately, this bare-minimum approach can leave organizations vulnerable to audits, citations, and escalating claim costs. In today’s regulatory environment, the best offense is not just fast injury reporting—it’s proactive follow-up, stra..
Using AI To Master The Art of Delegation
The biggest bottleneck in most businesses isn’t a lack of talent—it’s poor delegation. Leaders often:Hold on to too much work because they don’t trust their team to get it right.Micromanage because they think “it’s faster if I just do it myself.”Give vague instructions that lead to mistakes, frustration, and wasted time.The problem isn’t the team—it’s how leaders delegate. And AI is the game-changer that fi..
Neurodiversity in the Workplace and AI Applications
In this session, we explore the intersection of neurodiversity and artificial intelligence in the modern workplace. Speaker presents case studies and lived examples that show how neurodivergent team members, who may struggle with traditional social cues or synchronous communication, can thrive when provided with adaptive, AI-supported tools that respect their processing preferences. We will examine best pra..
Small Business Bookkeeping and Payroll Management on a Budget
Objective: Teach cost-effective methods for managing small business finances and payroll.Subtopics:Basics of Bookkeeping: Income, Expenses, and ReconciliationsChoosing Affordable Accounting Software (e.g., QuickBooks, others)Payroll Management: providers and compliance – payroll bookkeeping entriesTax Filing and Record-Keeping Best PracticesLet me know if you'd like me to expand on any of these outlines or ..
Change Control and Regulatory Impact Assessment
Change is an inevitable part of any regulated industry. However, without a structured approach to managing changes, organizations may face compliance violations, product failures, and reputational damage. Change control is a formalized process that ensures all modifications—whether in materials, equipment, processes, or documentation—are reviewed, assessed, and implemented in compliance with regulatory requ..
Building a Go-to-Market Strategy in a New Territory
Drawing on experience supporting brands expanding across EMEA and North America, Kathryn will walk through how to build and validate a GTM plan tailored to new market conditions. She’ll cover everything from ICP research and narrative positioning to local sales enablement and partnership strategies.The session will include tools to help you assess market readiness, balance short- and long-term investment, a..