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Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA
FDA has substantial authority to oversee regulated companies and their operations. The primary purpose of FDA is to assure safe and effective products that will protect public health. Violations can have seriously adverse effects on products, and ultimately, on patients and consumers.The root of every company’s effort to defend its practices and products is through data and documentation, meaning both struc..
Computer System Validation (CSV) 3-Hours Boot Camp
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also ..
Utilizing a Proven Process When Conducting Sensitive, Internal Investigations
An internal investigation is a formal inquiry to determine whether workplace policies or regulatory practices have been violated. Investigations can follow :a complaintallegationsuspicion of misconductfraudharassment accusationsor many other reasons covered by federal, state and/or local employment laws.The goal of any internal investigation is to obtain a straightforward view of the facts:what happened?whe..
Bullying And Incivility in the Workplace: Is There an App for That?
All of us would like to come to work on Monday mornings knowing we will be treated respectfully and professionally. And if we find some uncivil behavior all we need to do is access our “civil app” and poof, it will be gone. Unfortunately, more and more employees feel the opposite they experience rude and discourteous misconduct from their boss, their colleagues, and even their customers or clients; an..
Strategic Leadership: Be the Person People Choose to Follow
The advanced people skills in this webinar include learning how to earn the gift of discretionary effort. Discretionary effort is the difference between the added value an employee can bring to a task, versus the minimum effort required to get by or make do, and still receive a paycheck. It takes a special kind of leader to achieve the environment of exceptional employee experience and workplace optimizatio..
Work Violence and Active Threat Response: Workplace Safety Unveiled
In today’s complex landscape, business leaders and employers face a sobering reality: workplace violence is an unfortunate trend that demands our attention. Join us for a deep dive into two critical topics:Workplace Violence Unveiled:- Understand the causes and subtle signs that precede violent incidents- Learn pre-attack indicators and effective de-escalation strategies- Prepare for difficult conversations..
Writing Investigations that Meet Regulatory Requirements
In this immersive 90-minute seminar, participants will embark on a comprehensive exploration of the critical landscape surrounding the creation of investigations that meet stringent regulatory requirements within the life sciences. The journey begins with a foundational understanding of the regulatory environment, delving into the vital role that compliance plays in shaping the integrity of scient..
Secrets to Winning in Office Politics
Is It Time to Reclaim Your Power?Are you ready to strategically navigate your workplace dynamics like a master chess player? This webinar will equip you with the skills to enhance your influence and access the most valuable asset at work: power.You’ll learn to distinguish between Good and bad politics and assess if you’re in a toxic environment that needs addressing.Understanding Workplace Politics: Bad pol..
The CMS Hospital Infection Prevention and Control and Antibiotic Stewardship Program: CMS Compliance Requirements 2025
A hospital must have an active infection control program throughout the facility to track, prevent and control infectious diseases, including Healthcare Associated Infections, or HAIs. Additionally, the hospital must have a program for the optimization of antibiotic use through stewardship. This program will discuss the changes CMS made to the infection control standards in 2019, and the interpretive guidel..
Leveraging AI for HR Excellence
In today's rapidly evolving business landscape, Human Resources (HR) professionals face the dual challenge of managing traditional HR functions while adapting to the digital age. Generative Artificial Intelligence (gAI) offers a remarkable opportunity to reshape HR practices, streamline processes, and unlock valuable insights. This session will explore the integration of AI into HR operations, focusing on h..
Remaining Duration: The Overlooked Aspect
This Webinar focuses on schedule updating, steps, and tips, for better results. We dive deep into each activity, especially those in progress, to measure or calculate:Work performed and the time it took (actual duration).Work yet to be performed and the time it is expected to take.We, further, compare the actual baseline and see how much we conform to the baseline, as things in construction projects, often ..
The 2024 Election is Over! Get Ready for Compliance Whiplash in 2025! Know What Employers Need to Know
President-Elect Donald Trump is poised to expand upon policies he implemented during his first term in office, such as those emphasizing limited government, states' rights and lower taxes. Additionally, it is anticipated that the newly elected president and his administration will target many Biden Administration policies on the environment, immigration, foreign policy and more. Many of these actions could ..
Employee Engagement to Attract and Retain Talent
As leaders, we need to realize that the wants and needs of our employees are changing. There are factors that lead to differences in employee job performance. A good manager needs to understand what causes those differences. Employee engagement is not the same thing as job satisfaction or job happiness. It’s not just happiness or satisfaction that matters, but how those emotions directly relate to the indiv..
The Federal Government and Artificial Intelligence: Concerns and Pitfalls
Now more than ever, federal contractors find themselves at the intersection of innovation and regulation, particularly in the realm of Artificial Intelligence. We’ve incorporated AI into a broad range of business systems, including those with the potential to affect employment decisions. For that reason, the OFCCP has issued new guidance called “The AI Guide”. The Guide provides answers to commo..
The Pregnancy Workers’ Fairness Act – Has It Impacted Employer Views on Pregnancy?
Anytime a new law is passed, there is a wave of uncertainty about what the new law actually requires. After all, could expect Congress to be able to publish regulations further identifying what the requires. Indeed, as with many over-employment laws, Congress delegated enforcement of the PWFA to the EEOC. The wait is now over, we finally have a set of final regulations? Or will we see challenges to the fede..