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.
During the webinar, we will discuss FDA's considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee.
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Both lenders and borrowers like to to use EBITDA as proof of repayment ability, but as noted earlier, it overestimates repayment ability.
Medical device submissions in the US and EU require precise project scheduling to ensure timely regulatory approvals.
Still unsure? Consider this: regulators are already discussing AI's implications for financial services.
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.
Fear of accounting often stems from not understanding the basics. Without knowing the difference between a debit and a credit-or how they flow into the income statement and balance sheet-you might miss opportunities to ask smart questions, flag errors, or explain financial issues to stakeholders. Worse, you might make decisions that unintentionally hurt your budget or your department's performance.
Ratio analysis helps lenders and analysts to determine a borrower's operating performance (profitability and productivity) and financial condition (liquidity, leverage, solvency) by rendering the financial statements into ratios.
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.
Advancements in technology have forced organizations to rethink business models.
This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
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.
Pharmaceutical manufacturing sites continuously compete within the same company to maintain production volumes and avoid closures.
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Going "beyond the basics" Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.
Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.
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.
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.
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.
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.
Advancements in technology have forced organizations to rethink business models.
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.
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Human Factors/ Usability is the analysis of how people interact with medical devices.
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. Throughout the course, learners will explore the features and capabilities of COPILOT for Excel, like basic navigation and data analysis.
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.
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.
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.
This webinar will equip business professionals with the tools to harness Microsoft 365 Copilot for smarter, AI-powered workflows.
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.
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).
Tired of manually creating hundreds of personalized letters or emails?
Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution.
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.
In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.
This webinar, Decoding FDA's 21 CFR Part 11 and EU Annex 11: Ensuring Compliance in Electronic Recordkeeping, provides a comprehensive understanding of regulatory requirements for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device industries.
We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.
Unlock the power of Excel's data analysis and Business Intelligence (BI) toolkit with Pivot Tables. Whether you're aiming to construct dynamic dashboards, conduct in-depth data analysis, or simply streamline data summaries for personal or business purposes, Pivot Tables are your key to success.
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.
What would you do if you had a chemical spill in your Plant? How would you respond? Would your Employees know what to do? Are you compliant with OSHA? This course will clearly train Employees on how to properly identify and correct chemical hazards in a Plant so a spill or hazardous release does not occur.
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
This webinar will provide a practical framework for identifying, analyzing, and addressing deviations in pharmaceutical and biopharmaceutical manufacturing.
Get ready to transform your Excel experience forever!
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Verification and validation of design inputs is a critical step in the development of medical devices.
As global trade undergoes profound changes, companies and governments must look beyond today's tariff challenges and prepare for a more complex, uncertain future.
This 60-minute webinar explores how ChatGPT can revolutionize technical writing by enhancing productivity, accuracy, and clarity in document creation.
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.
Global cash flow is critical to analyzing and underwriting commercial borrowers, especially smaller, privately held firms where the owners and the company are so closely bound together that their assets, liabilities, and income are comingled.
An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"
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?
Substandard product can exist even if the product itself is manufactured according to quality standards.
Fear of accounting often stems from not understanding the basics. Without knowing the difference between a debit and a credit-or how they flow into the income statement and balance sheet-you might miss opportunities to ask smart questions, flag errors, or explain financial issues to stakeholders. Worse, you might make decisions that unintentionally hurt your budget or your department's performance.
If a major workplace injury or illness occurred, what would you do? How would you properly investigate it? What could be done to prevent it from happening again? A properly executed accident/incident investigation drives to the root causes of the workplace accident to prevent a repeat occurrence.
This session is designed to eliminate that uncertainty. You'll learn how to read income statements, balance sheets, and cash flow statements with confidence. More importantly, you'll gain the skills to analyze what the numbers actually mean: profitability trends, liquidity issues, debt levels, and more. By the end of this training, you'll be able to speak the language of finance-and use it to your advantage.
This webinar, Decoding FDA's 21 CFR Part 11 and EU Annex 11: Ensuring Compliance in Electronic Recordkeeping, provides a comprehensive understanding of regulatory requirements for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device industries.
Join PowerPoint expert Ray for an immersive design journey that will transform your slides from ordinary to extraordinary.
Human error is the primary cause of quality and production losses in many industries.
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 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.
This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences.
Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date.
Discover how to turn your raw data into compelling visual stories in this engaging and practical Excel webinar. Whether you're new to charting or looking to sharpen your skills, this session covers everything you need to create clear, impactful charts that communicate insights at a glance.
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 combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Getting Started Building Reports and Dashboards"
Begin your journey into the world of AI with ChatGPT 101 - Beginner's Guide.
SOX compliance is more than just checking boxes-it’s about building a control environment that ensures the accuracy and integrity of financial data. One of the most critical areas to get right is Accounts Payable. With hundreds or thousands of transactions flowing through the AP process every month, any breakdown in controls can lead to serious financial misstatements.
Verification and validation of design inputs is a critical step in the development of medical devices.
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 is becoming prevalent.
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Unlock the art of emergency preparedness in this Emergency Preparedness Course. From fire safety essentials to flood preparedness, tornado survival strategies, bomb threat response, power outage readiness, and effective communication strategies - this course is your passport to effectively navigating and having confidence in dealing with these critical situations.
Both lenders and borrowers like to to use EBITDA as proof of repayment ability, but as noted earlier, it overestimates repayment ability.
This 60-minute webinar explores how ChatGPT can revolutionize technical writing by enhancing productivity, accuracy, and clarity in document creation.
Complying with IRS information reporting requirements can be a complex and frustrating process-especially when it comes to Forms 1099 and W-9.
Elevate your Excel prowess with this training. Aimed at users already versed in Excel's core functions (SUM, X/VLOOKUP, COUNTIF etc), this course introduces users to some of the new innovative functions added since 2020, exclusively available to Microsoft 365, Excel 2021 and Excel 2024 users.
In today's world of evolving technologies and businesses, financial organizations are taking on increasing levels of risk.
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.
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.
This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
Still unsure? Consider this: regulators are already discussing AI's implications for financial services.
What would your Employees do if someone gets seriously hurt in the workplace or at home?
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).
In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control.
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.
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 covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
This session will equip you with the knowledge and tools needed to identify risks, strengthen internal processes, and implement practical safeguards.
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."
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.
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.
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).
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.
EBITDA is a foundational metric in financial analysis but it's also one of the most misused.
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
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.
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.
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
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.
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.
Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.
What would your Employees do if someone gets seriously hurt in the workplace or at home?
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.
Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.
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.
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
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.
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.
This training helps you bridge the gap between financial analysis and impactful communication.
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.
Training programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths.
Effective technical writing is critical for successful regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Premarket Approval (PMA) submissions.
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.
EBITDA is one of the most commonly used financial metrics in business but also one of the most misunderstood.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
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.
This session will explain how to employ ratios to measure and evaluate a borrower’s performance and financial condition.
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
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.
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.
This 60-minute webinar provides a comprehensive guide on how to effectively prepare for regulatory inspections conducted by the FDA, EMA, and Notified Bodies.
Assessment of the cause for a non-compliance is a structured series of branching questions.
This training is your opportunity to eliminate that uncertainty.
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.
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.
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
A compliant training program is essential for ensuring personnel in GMP, GCP, and quality system-regulated environments are knowledgeable, competent, and audit-ready.
This interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s.
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.
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.
This webinar will equip business professionals with the tools to harness Microsoft 365 Copilot for smarter, AI-powered workflows.
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.
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.
If your spreadsheets are full of inconsistent data, awkward formatting, or endless copy-paste routines, you need Power Query!
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.
Effective Standard Operating Procedure (SOP) writing and management are critical for ensuring regulatory compliance and operational consistency.
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.
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.
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.
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.
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.
This webinar will provide a practical framework for identifying, analyzing, and addressing deviations in pharmaceutical and biopharmaceutical manufacturing.
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.
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.
The guidance on validation has been modified with the FDA's proposed draft guidance for Computer Software Assurance (CSA) in September 2022.
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.
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 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 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.
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.
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:
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
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.
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, tobacco and tobacco-related (e-liquid, cigars).
The FDA has been moving in the direction of newer technology in an effort to no longer be a bottleneck to industry innovation.
We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.
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?
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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