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Effective Communication Skills: It’s Not What You Say, But How You Say It!
Effective communication is about really listening to others without any blinders on, eliminating the gossip and rumor mill, reducing the causes of turnover by providing timely and appropriate recognition, leading employees through changes by transparency, correcting the poor performers by coaching them, and setting the standards in highly adhered to on-boarding and training standards. All we have in common ..
Human Error and Management Systems: Designing Errors Out
If you work in the GMP-regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “Responsibilities of the quality control unit.” and it states that “(a) There shall be a quality control uni..
Risk Based Design Control - The New Paradigm for Medical Device Design
If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together awkwardly, this webinar will give you a different perspective and a very different approach that you can use.If your design and manufacturing resources spend too much time on documentation and no..
What the FDA 483 Really Means — And How to Respond Like a Pro
An FDA Form 483 isn’t just a list of observations — it’s a statement about how the agency views your quality system.And the moment you receive one, the clock starts ticking.The days and weeks that follow are critical. How you respond to a 483 says more about your organization than the inspection itself. The content, structure, and tone of your response tell the FDA whether you’re serious about fixing the is..
3 Powerful Collaboration Strategies That Will Align Any Team
1️. Stand-Up Meetings & Daily Huddles That Drive ExecutionLearn how to facilitate daily Agile Stand-Up meetings that keep teams focused without wasting time.Use the same framework for weekly Leadership Meetings.2️. The “Empty the Cup” Method – Transforming Meetings into Trust-Building SessionsApply Ask Technology to increase possibilities in structured brainstorming sessions to eliminate judgment, encou..
Assertive Communication Style
This engaging program will help attendees grasp the concepts of assertive communication, distinguish between passive, assertive, and aggressive communication styles, and learn how to use assertiveness to overcome professional difficulties. Participants will gain real-world communication skills through role-playing, activities, and group discussions.By the end of the event, attendees will have learned how to..
Rituals for Resilience And Renewal: Simple Personal Habits to Power Performance And Productivity!
Forget time management. It’s a myth. The important resource to manage and cultivate is your energy. Energy is what allows you to be productive and do what you want to do. All the time in the world is useless if you don’t have the energy to get anything done!In today’s fast-paced, constantly changing world, people are stressed, overworked, burned out, uncertain of the future, and drained of their precious en..
Streamlining Regulatory Documentation - Tools and Techniques
Regulatory documentation is a critical component of compliance in industries such as pharmaceuticals, medical devices, and biotechnology. However, the process of creating, managing, and maintaining regulatory documents is often complex, time-consuming, and prone to inefficiencies. Organizations must navigate evolving regulatory requirements from agencies like the FDA, EMA, and ISO while ensuring documentati..
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..
Conquer your stress: Go from worrier to warrior
It's estimated that stress is responsible for 60-90% of doctor's visits, and one million workers miss work each day because of stress, costing companies $602 per employee per year, according to the American Institute of Stress.It is imperative that we recognize that stress is not the problem - it's our reaction to our stress, and we can learn to control it. Acquire cutting-edge self-care techniques - affirm..
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..
Mastering Executive Presence: Communicating with Authority and Influence
Executive presence isn’t just about how you look or sound — it’s about the trust, influence, and respect you command without saying a word. In today’s competitive business environment, strong communication paired with authentic executive presence is a critical leadership skill.This webinar will equip leaders with actionable strategies to enhance their executive presence, foster trust, and influence outcomes..
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 ..