Live Webinar
Collaboration Over Competition: How Teams Spark Unstoppable Creativity
In a world where technological evolution is accelerating, organizations face the challenge of staying ahead of the curve. This requires not just incremental improvements but groundbreaking innovations that can redefine industries. Such innovations are seldom the product of solitary effort; they emerge from the synergistic collaboration of diverse teams. This session delves into the transformative power of c..
Computer Software Assurance (CSA) Implementation with Focus on Industry Case Study
Computer Systems Validation (CSV) and Computer Software Assurance are both crucial aspects in ensuring compliance, reliability, and security in an FDA-regulated environment, but they differ in focus and execution.Objective: Understanding the distinctions between Computer Systems Validation (CSV) and Computer Software Assurance in FDA-regulated settings.Importance: Highlighting their roles in ensuring regula..
Exemplary Leadership: The Eight Actions Which Speak Louder Than Words
Inspire and influence your team members to achieve your goals as a team!Managers who will be promoted are the ones who not only manage efficiently but also lead their teams effectively. Learn how to work in a horizontal mode of operation, apply a consistent theory in leading your team, and teach critical leadership skills to members of your team, so each and every one of them can lead the team in your absen..
From Claims to Culture: A Holistic Approach to Workers’ Compensation
This holistic session explores how workers’ compensation can become a strategic asset when embedded into the fabric of an organization’s culture. Rather than operating as an isolated risk management tool, workers’ comp can reflect—and reinforce—how a company lives its values, supports its people, and delivers on its mission.We will start by examining the disconnect between claims management and organization..
Streamlining Validation of FDA-Regulated Systems: Knowing When You Are Doing Too Much or Not Enough
The data integrity principles of “ALCOA+,” Attributable, Legible, Contemporaneous, Original or “True Copy,” Accurate, Complete, Consistent, Enduring, and Available must all be met for FDA-regulated data. These must be tested and confirmed during validation of the FDA-regulated system.We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance ..
Implementing the Techniques Utilized by HR Strategic Business Partners
The role of the HR business partner is more important than ever now that there are more demands on HR to add value. More leaders are realizing that by making better use of their employees, they can better achieve the profitability goals of the business. In addition, more transactional HR work is being outsourced, so HR cannot only focus more on the strategic side of the business but is also being asked to m..
Top Ten Best Practices for Establishing a Coherent Validation Compliance Program to Support a Diverse Technology Landscape
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 discus..
Breaking Barriers: A Dive into Accessibility Fundamentals for a More Inclusive World
In today’s rapidly evolving world, the discourse surrounding accessibility and inclusivity has become more urgent than ever. As societies strive to ensure that every individual has the opportunity to participate fully in all aspects of life, understanding and implementing accessibility fundamentals is paramount. The webinar "Breaking Barriers: A Dive into Accessibility Fundamentals for a More Inclusive Worl..
Choosing the Right Contract and Delivery Method
The webinar includes coverage of types of contracts and delivery methods, starting with definitions. We then discuss types of contracts with characteristics and pros and cons of each of them. We discuss under what circumstances each type of contract would be recommended. Later, we discuss delivery methods and what they mean to the owner. Although delivery methods are not a type of contracting method, they a..
FDA Warning Letter - Consent Decree Software Validation
Computer system validations play a crucial role in the pharmaceutical, medical device, and many other FDA regulated industries to ensure the integrity, security, and compliance of critical computerized systems. Inadequate software validation can often lead to FDA 483s, Warning Letters, or even Consent Decrees. Deficiencies in these validations can have a significant impact on product safety and quality that..
From Clashes to Collaboration: Strategies for Effective Conflict Resolution
This one-hour webinar will provide practical tools to navigate and resolve conflicts in professional and personal settings. Attendees will learn key techniques for active listening, clear communication, and emotional management, helping to transform conflicts into opportunities for collaboration. The session will also explore strategies for fostering mutual understanding, building stronger relationships, an..
Internal Auditing to MDSAP Concepts and Practices in Aligning the Internal Audit Program
The Medical Device Single Audit Program (MDSAP) is a global initiative designed to standardize regulatory audits for medical device manufacturers. Meeting MDSAP requirements is critical for companies seeking to sell their products in participating countries. This session will uncover how internal audits play a pivotal role in ensuring compliance, enabling organizations to improve the quality of their proces..
Leading a Project and Team in Stressful Times:Supporting your Team’s Mental Health
The past few years have had tremendous mental health impacts on all of us. If ignored or handled badly, mental health issues can devastate you, your team, client relationships, and projects. You can support your staff and coworkers through these stressful times by learning how to openly, safely, and respectfully talk about mental health. With tools and an action plan, you can create an effective strategy to..
Rental Income and Expenses (IRC §280A)
It is common for a taxpayer to own more than one property. In some of these cases, the non-primary residence may be rental property, part rental/part personal, or casual rental. In each case, the taxpayer needs to follow the tax rules in determining the income and expenses associated with each of these properties. In this session, we take an in-depth review of IRC §280A. This section of the Code provid..
The Impact of the Likely Upcoming Trump Tax Changes
Objective: Analyze potential changes in tax policies and their implications for individuals and businesses.Subtopics:Overview of the 2017 Tax Cuts and Jobs Act (TCJA)Proposed Extensions and Modifications to TCJAChanges to Individual Tax Rates and BracketsBusiness Tax Implications: Corporate Rates and DeductionsSocial Security and Retirement Tax AdjustmentsPreparing for Policy Changes: Strategies and Plannin..