Test

Compressed Gas Storage Safety

What would your Employees do if someone gets seriously hurt in the workplace or at home?

Clinical Trial Risk Management: ICH E6(R3) and FDA Expectations

This 60-minute webinar on Clinical Trial Risk Management will provide a comprehensive overview of the evolving regulatory landscape under ICH E6(R3) and FDA expectations for risk-based quality management (RBQM).

Impact Assessment and Risk Management for Change Control

In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control.

Time-Saving Chart Tricks Every Excel User Should Know

Take your Excel charts from basic to brilliant in this power-packed session! Discover how to create more impactful data visualizations by mastering advanced charting techniques that most users never explore.

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

Electronic Payment Fraud Prevention Best Practices

This session will equip you with the knowledge and tools needed to identify risks, strengthen internal processes, and implement practical safeguards.

Decision Making and Human Error

Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention."

4-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.

PowerBI

In today's busy world, we are sometimes overwhelmed with huge amounts of data, sometimes that data can come from more than one table, or even more than 1 data source. Trying to make sense of this data can be an overwhelming task.

Data Integrity and Privacy: 21 CFR Part 11, Annex 11, & General Data Protection Regulation (GDPR)

During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizen's personal data when they reside in the European Union (EU).

Unlock Excel Power with Microsoft Copilot

Imagine having an expert assistant that helps you work faster and smarter in Excel. In this groundbreaking webinar, Microsoft Certified Trainer Ray will show you how Copilot transforms Excel from a simple spreadsheet tool into a powerful AI-powered productivity machine.

Understanding EBITDA: A Key Financial Metric

EBITDA is a foundational metric in financial analysis but it's also one of the most misused.

Medical Device Software Validation Meeting: FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.

Agile vs. Traditional Project Management in Life Sciences: Choosing the Right Approach

This 60-minute webinar explores the key differences between Agile and Traditional (Waterfall) Project Management in the life sciences industry, helping professionals determine the best approach for their specific projects

Using ChatGPT with Excel

This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.

Estimating Seasonal Borrowing Needs and Ability to Repay

One of the most basic analytical and underwriting tools a banker must have is the ability to determine whether a borrower can repay its short-term borrowings based on the financial information available

Financial Statement Ratio Analysis

The fear is real-many professionals nod in meetings where financials are discussed, but don't fully understand what the ratios mean or how they relate to strategic decisions.

Function, Preparation, and Execution of Job Aids in the Pharmaceutical Industry

Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.

Regulatory Requirements for Personnel Training to Assure QSR and ISO Compliance

Ensuring that personnel are properly trained is critical for maintaining compliance with Quality System Regulations (QSR) and ISO standards in regulated industries such as medical devices and pharmaceuticals.

How to Prepare for and Host an FDA Inspection and Respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Bloodborne Pathogens (BBP) Training

What would your Employees do if someone gets seriously hurt in the workplace or at home?

Nonconformance/CAPA: Five (5) Improvements with Impact

This presentation will outline five targeted improvements to enhance the quality and effectiveness of Nonconformance and CAPA records. In addition to strengthening record content, it will offer practical guidance to support sound decision-making throughout the Nonconformance and CAPA process. Each improvement will be accompanied by real-world examples and actionable steps to support successful implementation.

Agile and Traditional Project Management Perfect together - A Hybrid Approach

This webinar explores the power of Hybrid Project Management, combining the structured, predictable approach of traditional Waterfall methodologies with the flexibility and adaptability of Agile practices.

Validation Sampling Plans, Setting Acceptance Specifications, and Statistical Process Control

Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.

Excel Meets AI - How Microsoft Copilot Can Save You Time

This training is designed to revolutionize the way you work with Excel. Copilot is an AI-powered tool that enhances your Excel experience by automating complex tasks, providing intelligent suggestions, and improving overall efficiency. Whether you're dealing with large datasets, creating intricate formulas, or simply trying to streamline your daily workflow, Copilot is here to help.

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.

4-Hour Virtual Seminar on How to Write Better Communications and Emails

Good leaders walk the talk, but they also write right. They know how to say in a few words what needs to be said in crisp, clear language.

Financial Storytelling: Presenting Your Numbers with Confidence

This training helps you bridge the gap between financial analysis and impactful communication.

Best Practices in Preparation for an FDA Computer System Audit

FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules.

How to Formally Measure Training Effectiveness

Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths.

Best Practices for Technical Writing in Regulatory Submissions: INDs, NDAs, and PMAs

Effective technical writing is critical for successful regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Premarket Approval (PMA) submissions.

Project Management: A Primer

Project Management: A Primer is a comprehensive introductory session designed to provide participants with a solid foundation in project management principles and practices.

Trends in FDA Compliance and Enforcement for Regulated Systems

FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.

Understanding EBITDA - Definition, Formula & Calculation

EBITDA is one of the most commonly used financial metrics in business but also one of the most misunderstood.

Excel Meets AI - Using ChatGPT with Excel

In today's fast-paced and data-driven world, efficiency, accuracy, and innovation are more critical than ever.

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

6-Hour Virtual Seminar on Project Management for Non-Project Managers

What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.

How to use Financial Statement Ratios in Credit Analysis

This session will explain how to employ ratios to measure and evaluate a borrower’s performance and financial condition.

4-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.

Excel + AI: The Smart User's Guide to Faster, Easier Work with ChatGPT

AI isn't just a buzzword - it's a game-changer for Excel users. In this hands-on session, you'll discover how to combine the power of Excel with ChatGPT to boost your productivity, simplify complex tasks, and unlock new levels of efficiency. Whether you’re stuck writing tricky formulas, wrangling messy data, or building dashboards, ChatGPT can become your on-demand assistant.

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.

CoPilot for HR Professionals

This course is designed to equip HR professionals with the tools and know-how to harness Microsoft 365 Copilot and Copilot Studio to transform HR workflows. In this course, you’ll explore hands-on use cases-from recruitment and onboarding to employee engagement and policy development-empowering HR teams to become more productive, data-driven, and employee-centric.

How to Prepare for a Regulatory Inspection: FDA, EMA, and Notified Body Audits

This 60-minute webinar provides a comprehensive guide on how to effectively prepare for regulatory inspections conducted by the FDA, EMA, and Notified Bodies.

How to Deal with Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions.

Using CoPilot with Excel

This course is designed to teach learners how to use COPILOT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.

Introduction to CoPilot for Business Professionals

This webinar will equip business professionals with the tools to harness Microsoft 365 Copilot for smarter, AI-powered workflows.

Understanding Financial Statements for Non-Financial Professionals

This training is your opportunity to eliminate that uncertainty.

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future

One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.

6-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

How to Reduce Human Error in a GMP Manufacturing/Floor

If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it.

Excel for Financial Analysis Beyond Basic Formulas

Financial professionals know that data is only as valuable as your ability to analyze it.

6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting Your Regulatory and Processing Responsibilities

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

Building a Compliant Training Program for GMP, GCP, and Quality Systems

A compliant training program is essential for ensuring personnel in GMP, GCP, and quality system-regulated environments are knowledgeable, competent, and audit-ready.

Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

This interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s.

How to Effectively Navigate OSHA Compliance Audits

OSHA inspections can happen with little or no notice. Being unprepared can result in citations, fines, and operational disruption. This session delivers practical steps to prepare for, manage, and follow up on OSHA audits to achieve the best possible outcome.

Break Free from Old Excel: How Dynamic Arrays Transform Formula Creation

If you're still building formulas the old way - one cell at a time, you're missing out on one of Excel's most powerful modern features: dynamic arrays.

3-Hour Virtual Seminar on Get started with ChatGPT and Copilot in Excel

This course is designed to teach learners how to use ChatGPT for Excel and CoPilot for Excel. ChatGPT and CoPilot are powerful AI tools that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of ChatGPT for Excel and CoPilot for Excel, like basic navigation and data import/export.

The Transfer of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

Introduction to CoPilot for Business Professionals

This webinar will equip business professionals with the tools to harness Microsoft 365 Copilot for smarter, AI-powered workflows.

Validating FDA-Regulated Systems Using AI, ML & LLMs, such as ChatGPT

As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI, ML and ChatGPT and others are becoming prevalent.

The DHF, DMR, DHR, and the Technical Documentation File - The US FDA and EU MDR Requirements

This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.

Human Error Solutions: How We Reduced 60% of Human Errors in Less Than a Year, a Case Study

Pharmaceutical manufacturing sites continuously compete within the same company to maintain production volumes and avoid closures.

Excel Data Mastery Interactive PivotTables & Dashboards for Finance Pros

Transform your financial data analysis with next-level PivotTable techniques!

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and The New FDA Draft Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices.

Budgeting & Forecasting Basics: Build a Rolling 12-Month Model

Budgeting and forecasting are at the heart of sound financial management. But while many organizations still rely on static annual budgets, these tools often fall short in fast-changing environments. A rolling 12-month model offers a dynamic alternative, providing continuous visibility into financial performance and keeping leadership aligned with evolving business conditions.

Heat Stress Avoidance Training

Exposure to high temperatures-indoors or outdoors-can lead to serious heat-related illnesses, reduced productivity, and even fatalities. This training provides proven strategies to recognize, prevent, and respond to heat stress hazards in compliance with OSHA recommendations.

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences.

Excel: Stop Cleaning Data Manually Let Power Query Do It

If your spreadsheets are full of inconsistent data, awkward formatting, or endless copy-paste routines, you need Power Query!

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.

Finance Dashboard Lab in Excel: From Trial Balance to Exec KPIs

Creating a financial dashboard in Excel from a trial balance involves several key steps, from data preparation to calculating and visualizing executive-level key performance indicators (KPIs). A well-structured dashboard allows leaders to quickly assess financial health, track performance, and make informed decisions without wading through detailed reports.

Get started with Microsoft Copilot

This course is designed to equip business professionals with the tools and know-how to harness Microsoft 365 Copilot to help with everyday tasks. In this course, you will see examples of using CoPilot in Word, PowerPoint, Excel, Outlook, Teams, and Bing. It will use the CoPilot add-on for Microsoft Office 365.

Power BI for Beginners - Turn Data into Decisions

Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI for Beginners - Turn Data into Decisions"

Excel Pivot Tables

We will start with the basics and built up to more complex pivot tables.

Excel's AI Revolution: Master ChatGPT's Advanced Functions

Join us for an exciting and interactive webinar where we dive into the world of AI-powered Excel with the ChatGPT Add-In.

Effective SOP Writing and Management for Regulatory Compliance

Effective Standard Operating Procedure (SOP) writing and management are critical for ensuring regulatory compliance and operational consistency.

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

Validating FDA-Regulated Systems Supporting Medical Devices & SaMD Products Using AI, ML & LLMs, such as ChatGPT

As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI, ML and ChatGPT and others are becoming prevalent.

How to use CoPilot for Excel

This course is designed to teach learners how to use COPILOT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

Eye and Face Protection (PPE) - Beyond Basics

Workplace eye and face injuries are preventable when the correct protective equipment is properly selected and used. This session dives deeper than PPE basics to address hazard-specific protection, compliance requirements, and effective program management.

4-Hour Virtual Seminar on Credit Risk Management- Principles and Practices, Tools and Techniques

Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives.

The DHF, DMR, DHR, and the Technical Documentation File - The US FDA and EU MDR Requirements

This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.

How to use ChatGPT & Microsoft Copilot for Project Management

Discover how AI can supercharge your project management workflows.

Medical Device Change(s) and the 510(k)

This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).

Excel PowerQuery and PowerPivot

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

PowerPoint Advanced Techniques - Build A Video Presentation

Mastering advanced PowerPoint techniques is a powerful asset across diverse industries including marketing, social media, public service, banking, accounting, financial analysis, and business administration.

Medical Device Software Validation Meeting: FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.

How to Implement an Effective Human Error Investigation Program

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 do it because the regulation requires it.

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

Verification and validation requirements have always been part of the US FDA's GMPs. Yet companies still struggle with the performance of and documentation of Equipmnet, Process, Software, and quality management system validations.

OSHA Requirements for Temporary Workers

Temporary and contract workers face unique safety challenges. OSHA’s joint employer doctrine makes both the staffing agency and host employer responsible for safety. This webinar explains how to protect temporary workers and ensure compliance.

Forecasting in Excel: Scenario Planning with What If and Solver

Forecasting in Excel uses What-If Analysis and Solver to analyze different scenarios and find optimal outcomes.

Agile Principles and Practices: A Primer

Our Agile primer is a comprehensive introductory session designed to unlock the transformative power of agile methodologies for professionals across all industries. This course takes participants on a journey through the fundamental principles that have revolutionized how teams approach problem-solving, decision-making, and value delivery in fast-changing environments.

Data Dominance Create, Filter, Sort, and Customize Like a Power User

Ready to transform chaotic data into organized insights?

Pivot Tables - The Secret to Fast, Flexible Excel Reporting

Pivot Tables are one of Excel’s most powerful and misunderstood tools but once you know how to use them, they can transform how you analyse and report on data. In just a few clicks, you can summarise thousands of rows into meaningful, dynamic reports - no formulas required.

Copilot vs. ChatGPT: What's the Difference?

AI tools are transforming the way we work—but not all tools are the same. In this 60-minute session, we’ll demystify the differences between Microsoft Copilot and ChatGPT, showing when to use each and how they can complement each other.

Root Cause Analysis and CAPA Implementation for GMP Compliance

This webinar will provide a practical framework for identifying, analyzing, and addressing deviations in pharmaceutical and biopharmaceutical manufacturing.

PowerBI

In today's busy world, we are sometimes overwhelmed with huge amounts of data, sometimes that data can come from more than one table, or even more than 1 data source. Trying to make sense of this data can be an overwhelming task.

The Q-Submission Program Guidance for Medical Device Submissions to FDA

Providing safe and effective medical devices is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. You will learn about the Q-Submission program providing industry with pathways for engaging FDA early for feedback to aid in product development.

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

Mastering PivotTables- Excels Ultimate Tool for Smarter Data Management

Discover how to turn complex data into clear, actionable insights-fast! PivotTables are one of Excel’s most powerful tools, allowing you to instantly summarize, filter, group, and analyze large data sets with just a few clicks.

Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project Review Meetings

This webinar is about effective communication inside and outside of the project team.

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

The Human Error Toolbox: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented.

How to use ChatGPT & AI for Project Management to Improve FDA Compliance for Computer Systems & Data

The guidance on validation has been modified with the FDA's proposed draft guidance for Computer Software Assurance (CSA) in September 2022.

4-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.

4-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.

How to Prepare for and Host an FDA Inspection and Respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Modern Excel: The New Functions That'll Change How You Work

Excel has changed. Have you? Over the past few years, Microsoft has added a wave of powerful new functions that simplify tasks, streamline formulas, and make your spreadsheets more dynamic than ever. If you're still relying solely on old favourites like VLOOKUP, IF, and COUNTIF, you're missing out on what's now possible.

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.

Excel Data Mastery Smart Calculations, Automation & Reporting for Finance Professionals

Turn Financial Data into Actionable Insights - Faster Than Ever

OSHA's Global Harmonized Standard (GHS) / HazCom

OSHA’s Hazard Communication Standard is undergoing major changes in 2025. This training reviews the updated labeling, SDS requirements, and chemical classification standards - and how to implement them efficiently.

Project Management for Non-Project Managers - Determining the Work that Needs to be Done

This webinar will walk the participant through the entire process of decomposing a project's tasks into workable schedulable elements called work packages.

Project Management: A Primer

Project Management: A Primer is a comprehensive introductory session designed to provide participants with a solid foundation in project management principles and practices.

ChatGPT for Excel

This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.

5S for Operators and Human Error Reduction

Human error is the primary cause of quality and production losses in many industries.

Unlock Excel Power with Microsoft Copilot

Imagine having an expert assistant that helps you work faster and smarter in Excel. In this groundbreaking webinar, Microsoft Certified Trainer Ray will show you how Copilot transforms Excel from a simple spreadsheet tool into a powerful AI-powered productivity machine.

6-Hour Virtual Seminar on Project Management for Non-Project Managers

What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.

Risk Management for AI in Medical Devices: Insights from FDA's Lifecycle Management Draft Guidance

The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called "locked" algorithms that don't continually adapt or learn every time the algorithm is used.

Organizational Change Management for Transformation: A Primer

A Primer is a comprehensive introductory session designed to provide participants with essential knowledge and practical tools for navigating organizational change successfully.

Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements

This webinar, Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements, provides a comprehensive overview of data integrity principles, regulatory expectations, and compliance strategies in pharmaceutical and clinical environments.

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

4-Hour Virtual Seminar on How to Write Better Communications and Emails

Good leaders walk the talk, but they also write right. They know how to say in a few words what needs to be said in crisp, clear language.

Capital Budgeting Made Simple: NPV, IRR, Payback for Managers

Capital budgeting is the process of evaluating investment opportunities to determine which projects will generate the most value for an organization. Key financial metrics such as Net Present Value (NPV), Internal Rate of Return (IRR), and payback period are central to this evaluation, but they are often perceived as complicated or intimidating. This session breaks these concepts down in simple, practical terms.

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Forecasting in Excel: Scenario Planning with What-If and Solver

Forecasting allows organizations to anticipate outcomes, plan resources, and make informed decisions.

QMS 101: Quality Management System Guide

ISO 9001 is an internatioinal standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.

Excel - A Beginner's Guide to Formulas

Excel is an essential tool for anyone who works with data, from entry-level employees to professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.

ChatGPT 101 - Beginners Guide

Begin your journey into the world of AI with ChatGPT?101 - Beginner's Guide.

Decision Making and Human Error

Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention."

Excel Essentials for Finance Pros SUM, SORT & Speed Up Your Workflow

Unlock the Power of Excel for Finance & Accounting!

Project Management for Non-Project Managers - Scheduling Your Project

This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.

How to Deal with Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions.

Cash Flow 101: From Profits to Liquidity You Can Spend

Cash flow is the lifeblood of every business. While profitability shows how well a business performs on paper, cash flow reveals whether the business can sustain itself in reality. Understanding this difference is essential for anyone responsible for managing or analyzing financial performance.

Regulatory Requirements for Personnel Training to Assure QSR and ISO Compliance

Ensuring that personnel are properly trained is critical for maintaining compliance with Quality System Regulations (QSR) and ISO standards in regulated industries such as medical devices and pharmaceuticals.

Word PowerUser Techniques in Document Formatting MasterClass

Mastering power-user techniques in Microsoft Word is a game-changing skill across many professional fields-including public service, banking, accounting, financial analysis, and business administration.

Internal Controls for AP/AR: 12 Practical Checks to Reduce Errors and Fraud

Internal controls are essential for safeguarding an organization's financial resources, and AP/AR processes are particularly vulnerable to errors and fraud.

ChatGPT for PowerPoint Essentials Made Easy

A customized practical PowerPoint example is provided with slides in sequence for each question posed to ChatGPT for demonstration and “hands-on” practice by attendees

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future

One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements.

6-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

How to Prepare and Survive an OSHA Audit

Regulatory Compliance Audits can be taxing and worrisome for anyone. Having an OSHA Audit an open an organization up to receiving regulatory citations, monetary fines, negative company press, etc.

Storytelling in Project Management for Validating FDA-Regulated Computer Systems: How to Captivate & Inspire the Team

By applying storytelling to FDA-regulated system validation, attendees will:

ChatGPT / AI for Project Management for FDA-Regulated Companies

This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.

Finance for Sales Managers: Pricing Discipline and Discount Guardrails

Pricing and discounting decisions are critical levers for driving revenue while maintaining profitability. Sales managers need to understand the financial impact of these decisions to balance short-term sales goals with long-term business sustainability.

Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Financial Storytelling: Presenting Results to Executives in 10 Slides

Financial storytelling combines data analysis, communication skills, and strategic insight to deliver impactful presentations to executives.

Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA's Recent Draft Guidance for Electronic Records/Signatures used in Clinical Trials

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.

How to Use Copilot for PowerPoint

Take your presentations from blank slides to polished decks in a fraction of the time. In this 60-minute webinar, you’ll learn how Microsoft Copilot can help you create, design, and refine PowerPoint presentations with ease.

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

AI in Drug Development

The US FDA has announced steps toward a new regulatory policy and framework specifically tailored to promote the development of safe and effective drugs using advanced artificial intelligence / machine learning algorithms by the regulated industry.

KPI Design That Non-Finance Teams Will Actually Use

KPIs are only valuable if they are understood and acted upon.

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

How to Use Copilot for Project Management

Managing projects often means juggling documents, timelines, data, and endless communication. In this 60-minute webinar, discover how Microsoft Copilot can transform the way you plan, track, and deliver projects.

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.

Device Changes, FDA Changes, and the 510(K)

This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).

Variance Analysis for Busy Managers: Budget vs Actuals Made Simple

Variance analysis is at the core of effective financial management and performance review. By comparing budgeted expectations to actual results, managers can understand not only whether targets were met but also why outcomes differed. This knowledge is essential for adjusting strategies, managing resources, and improving future forecasts.

How to Use CoPilot for Excel

Discover how Microsoft Copilot supercharges project management with Microsoft Project. In this 60-minute session, you’ll learn practical ways to leverage Copilot to streamline task planning, risk management, status reporting, and more-all within the familiar Microsoft Project interface.

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Trends in FDA Compliance and Enforcement for Regulated Systems

FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules.

2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification

This Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure.

Working Capital Essentials: Receivables, Payables, and Inventory Levers

Working capital management is one of the most important, yet often underappreciated, aspects of financial management. It determines a company’s ability to meet short-term obligations, fund operations, and seize new opportunities. By focusing on the three main levers-receivables, payables, and inventory-businesses can strengthen liquidity and improve efficiency.

Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

How to Use CoPilot for Excel

This course is designed to teach learners how to use COPILOT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.

FDA Guidance for use of Social Media by Regulated Industries (Updated to include Recent Guidance from FDA)

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, tobacco and tobacco-related (e-liquid, cigars).

Month-End Close Playbook: Close Faster with Fewer Surprises

Month-end close is essential for accurate financial reporting and timely management insights, but it often presents challenges that delay reporting and create errors.

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Tech. Doc, n Files - The US FDA and EU MDR Rqmts

This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.

Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning Agile to the GAMP®5 "V" Model & System Development Life Cycle (SDLC)

The FDA has been moving in the direction of newer technology in an effort to no longer be a bottleneck to industry innovation.

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

ChatGPT & AI for Project Management

This 90-minute webinar will begin with an introduction to the fundamentals of project management, tailored specifically for those who may not have formal training in the field.

ChatGPT for Excel

This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

Verification and validation requirements have always been part of the US FDA's GMPs.

Excel Pivot Tables

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts.

GAMP®5, 2nd Edition and Alignment with FDA's Draft Guidance for Computer Software Assurance (CSA)

We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.

ChatGPT and Project Management: Leveraging AI for Project Management Excellence

The integration of artificial intelligence (AI) into project management is transforming the way projects are planned, executed, and monitored.

Payment Fraud Red Flags: Protect Your Payables Today

Payment fraud is a significant risk for organizations, particularly within accounts payable.

Excel Power Query and PowerPivot

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data, & FDA Compliance

So what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far?

4-Hour Virtual Seminar on ChatGPT for Project Management from Essentials to Advanced

Participants will want to attend this seminar to gain practical and actionable skills that will revolutionize their approach to project management.

3-Hour Virtual Seminar on Get started with ChatGPT and Copilot in Excel

This course is designed to teach learners how to use ChatGPT for Excel and CoPilot for Excel.

Data Integrity and Governance for Computer Systems Regulated by FDA

Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry.

Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.

Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability & Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)

Similarly, HIPAA and GDPRs extend protections to consumers residing in the US and the EU.

Best Practices in Preparation for an FDA Computer System Audit

In particular, industry citations have increased as they relate to areas of Part 11 and data integrity.

Using IT Audit Trails to Support FDA 21 CFR Part 11 and Data Integrity Compliance

FDA's recent focus on 21 CFR Part 11 and data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries.