This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences.
If your spreadsheets are full of inconsistent data, awkward formatting, or endless copy-paste routines, you need Power Query!
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.
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.
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.
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"
We will start with the basics and built up to more complex pivot tables.
Join us for an exciting and interactive webinar where we dive into the world of AI-powered Excel with the ChatGPT Add-In.
Effective Standard Operating Procedure (SOP) writing and management are critical for ensuring regulatory compliance and operational consistency.
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
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.
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.
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.
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.
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.
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.
Discover how AI can supercharge your project management workflows.
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).
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.
Mastering advanced PowerPoint techniques is a powerful asset across diverse industries including marketing, social media, public service, banking, accounting, financial analysis, and business administration.
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.
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.
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.
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 uses What-If Analysis and Solver to analyze different scenarios and find optimal outcomes.
GMP-Regulated Manufacturing (Pharma, Biologics, Medical Devices, Food & Nutrition).
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.
Ready to transform chaotic data into organized insights?
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.
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.
This webinar will provide a practical framework for identifying, analyzing, and addressing deviations in pharmaceutical and biopharmaceutical manufacturing.
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.
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
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.
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.
This webinar is about effective communication inside and outside of the project team.
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.
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.
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.
The guidance on validation has been modified with the FDA's proposed draft guidance for Computer Software Assurance (CSA) in September 2022.
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.
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
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.
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.
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.
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.
Turn Financial Data into Actionable Insights - Faster Than Ever
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.
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 is a comprehensive introductory session designed to provide participants with a solid foundation in project management principles and practices.
Human error is the primary cause of quality and production losses in many industries.
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.
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.
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.
A Primer is a comprehensive introductory session designed to provide participants with essential knowledge and practical tools for navigating organizational change successfully.
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.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
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.
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.
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.
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 allows organizations to anticipate outcomes, plan resources, and make informed decisions.
This session is designed to eliminate that uncertainty.
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 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.
Begin your journey into the world of AI with ChatGPT?101 - Beginner's Guide.
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."
Unlock the Power of Excel for Finance & Accounting!
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.
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.
Assessment of the cause for a non-compliance is a structured series of branching questions.
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.
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.
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 are essential for safeguarding an organization's financial resources, and AP/AR processes are particularly vulnerable to errors and fraud.
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
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements.
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
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.
By applying storytelling to FDA-regulated system validation, attendees will:
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.
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.
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 combines data analysis, communication skills, and strategic insight to deliver impactful presentations to executives.
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
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.
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 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.
KPIs are only valuable if they are understood and acted upon.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
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.
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.
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.
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 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.
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.
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.
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 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 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.
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
SOX compliance is more than just checking boxes-it's about building a control environment that ensures the accuracy and integrity of financial data.
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.
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.
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.
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 is essential for accurate financial reporting and timely management insights, but it often presents challenges that delay reporting and create errors.
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.
The FDA has been moving in the direction of newer technology in an effort to no longer be a bottleneck to industry innovation.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
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.
Complying with IRS information reporting requirements can be a complex and frustrating process-especially when it comes to Forms 1099 and W-9.
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.
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.
Verification and validation requirements have always been part of the US FDA's GMPs.
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.
We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.
The integration of artificial intelligence (AI) into project management is transforming the way projects are planned, executed, and monitored.
EBITDA is a foundational metric in financial analysis but it's also one of the most misused.
Payment fraud is a significant risk for organizations, particularly within accounts payable.
Project management is no longer limited to technical experts or team leaders - administrative professionals play a critical role in ensuring projects run smoothly from start to finish.
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.
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?
Participants will want to attend this seminar to gain practical and actionable skills that will revolutionize their approach to project management.
This course is designed to teach learners how to use ChatGPT for Excel and CoPilot for Excel.
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.
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.
Similarly, HIPAA and GDPRs extend protections to consumers residing in the US and the EU.
In particular, industry citations have increased as they relate to areas of Part 11 and data integrity.
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.
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