Test

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.

Excel ChatGPT MasterClass 4 - Gain the Competitive Advantage

A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.

How Countries Negotiate TARIFFS, Trade Deals, and Agreements, and Their Effect on Global Markets

Trade deals and tariff negotiations are key tools governments use to influence economic outcomes, build alliances, and protect domestic industries.

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.

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 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 - 10 Key Worksheet Functions to Skyrocket Your Productivity

An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"

C for Yourself: The 5 C's of Credit

The first four C's-capacity, conditions, collateral, and character- evaluate a borrower's ability to repay, but character forces the lender to examine closely the borrower's willingness to repay.

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.

How Accountants can use ChatGPT Effectively

ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.

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.

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.

Excel Power Query and Power Pivot

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.

Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

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.

Excel Lookup Functions XLookup & Error Suppression

Going "beyond the basics" Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.

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.

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.

Story-Driven Leadership: Using Storytelling to Energize Project Teams

In today's fast-paced and highly analytical project environments, leaders often rely heavily on metrics, deadlines, and documentation to steer their teams.

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.

Navigating Storms: Mastering Change Without the Chaos

Navigating Storms: Mastering Change Without the Chaos is an intensive workshop designed to transform leaders into confident change navigators who can guide their teams through any organizational transition with skill and composure.

Using Gemini with Google Sheets

This course is designed to teach learners how to use Gemini AI with Google Sheets, a powerful tool that can help you automate tasks, analyze data, and create reports in Google Sheets.

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.

The Importance of Packaging and Labeling in Pharmaceutical Product Development

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.

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.

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).

Power BI - Getting Started Building Reports and Dashboards

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"

Cash Flow Analysis of Borrower's Repayment Ability

There is an old saying in credit analysis, "Borrowers pay back loans from cash flow, not profits."

Word Professional Formatting Techniques Beyond the Basics

Mastering Power-User techniques in Microsoft Word is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.

Understanding Artificial Intelligence (AI) and the Incredible Uses and Fallbacks of ChatGPT

ChatGPT has been created with one main objective - to predict the next word in a sentence, based on what's typically happened in the gigabytes of text data that it's been trained on.

Mastering Cross-Functional Collaboration in Research & Development

Effective collaboration between diverse corporate functions is critical for success in Research & Development (R&D).

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. Throughout the course, learners will explore the features and capabilities of COPILOT for Excel, like basic navigation and data analysis.

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.

Excel - Build Advanced Pivot Table Solutions

This course is not appropriate for Mac or Excel for Web users as the functionality does not exist on those platforms.

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.

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.

Tariffs & Beyond: Future of Global Trade Dynamics and International Business Practices

As global trade undergoes profound changes, companies and governments must look beyond today's tariff challenges and prepare for a more complex, uncertain future.

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.

Build A New Roadmap to Success Using Strengths

Building A New Roadmap to Success Using Strengths is a designed to transform how leaders approach team development and performance optimization through the powerful lens of strengths-based leadership.

Risk Management Strategies for Life Science Projects

Effective risk management is essential for ensuring the success of life science projects, where regulatory compliance, operational efficiency, and financial sustainability are critical.

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance with FDA's guidance.

Strategies To Prevent the Manufacture and Distribution of Substandard Medications

Substandard product can exist even if the product itself is manufactured according to quality standards.

Think Straight to Decide Right: Introduction to Critical Thinking

Every day we deal with issues and hope to resolve them correctly, quickly, and cheaply.

Excel - Beyond the Bar Chart - Data Visualization and Data Story Telling Techniques Overview

Revolutionize the way you communicate data with this cutting-edge training on Excel visual storytelling. Discover the power of visual data representation to transform complex numerical information into compelling, insightful visual narratives.

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.

Excel ChatGPT MasterClass 3 - Work Smarter and Faster

A customised practical Excel Worksheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.

Finance and Accounting 101 Simplified

Finance & Accounting 101 Simplified strips away the jargon and explains key financial and accounting concepts in everyday 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.

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.

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.

Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.

Internal Controls in Accounts Payable

This session is designed to help you recognize these risks and take action.

3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.

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.

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. This session will introduce you to the seamless integration of ChatGPT with Excel, showing how AI can dramatically boost your spreadsheet capabilities.

Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA

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.

Excel ChatGPT MasterClass 5 - Achieve More in Less Time

A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.

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.

Why EBITDA Doesn't Spell Cash Flow But What Does

Both lenders and borrowers like to to use EBITDA as proof of repayment ability, but as noted earlier, it overestimates repayment ability.

Project Scheduling Techniques for Medical Device Submissions in US and EU

Medical device submissions in the US and EU require precise project scheduling to ensure timely regulatory approvals.

ChatGPT for CPAs and Finance Professionals

Still unsure? Consider this: regulators are already discussing AI's implications for financial services.

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 Vital Introductory Essentials with Tips & Shortcuts

This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.

Accounting For Non-Accountants: Debit, Credits And Financial Statements

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.

How to use Financial Statement Ratios in Credit Analysis

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.

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.

FDA Compliance for Regulated Systems using COTS, Cloud, and SaaS Solutions

Advancements in technology have forced organizations to rethink business models.

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats

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.

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.

FDA Regulation of Artificial Intelligence/ Machine Learning

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

Excel Lookup Functions Xlookup & Error Suppression

Going "beyond the basics" Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.

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.

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.

Excel Power Query and Power Pivot

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.

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

Advancements in technology have forced organizations to rethink business models.

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.

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.

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.

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.

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.

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.

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.

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.

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).

Automate Your Office - Professional Mail Merge Techniques

Tired of manually creating hundreds of personalized letters or emails?

The Importance of Packaging and Labeling in Pharmaceutical Product Development

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.

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.

Decoding FDA's 21 CFR Part 11 and EU Annex 11: Ensuring Compliance in Electronic Recordkeeping

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.

GAMP®5, 2nd Edition & 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.

Excel - Reporting Simplified - Learn Pivot Tables from Scratch

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.

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.

Trial Master File (TMF)/eTMF, & FDA's 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.

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.

ChatGPT for Excel Add-in Essentials and AI Function Mastery

Get ready to transform your Excel experience forever!

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.

Tariffs & Beyond: Future of Global Trade Dynamics and International Business Practices

As global trade undergoes profound changes, companies and governments must look beyond today's tariff challenges and prepare for a more complex, uncertain future.

ChatGPT & Technical Writing use the Tool to Boost Your Productivity and Writing Quality

This 60-minute webinar explores how ChatGPT can revolutionize technical writing by enhancing productivity, accuracy, and clarity in document creation.

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.

The World of Global Cash Flow - Is There Enough to Cover All Debts

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.

Excel - 10 Key Worksheet Functions to Skyrocket Your Productivity

An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"

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?

Strategies To Prevent the Manufacture and Distribution of Substandard Medications

Substandard product can exist even if the product itself is manufactured according to quality standards.

Accounting For Non-Accountants: Debit, Credits And Financial Statements

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.

Understanding and Analyzing Financial Statements

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.

Decoding FDA's 21 CFR Part 11 and EU Annex 11: Ensuring Compliance in Electronic Recordkeeping

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.

Design Like a Pro SmartArt, Charts, and Organization Charts in PowerPoint

Join PowerPoint expert Ray for an immersive design journey that will transform your slides from ordinary to extraordinary.

5S for Operators and Human Error Reduction

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

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.

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.

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.

Using a Learning Management System (LMS) to Develop Pharma Training Curricula

Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date.

Excel Charting Essentials From Setup to Stunning Visuals

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.

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.

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.

Power BI - Getting Started Building Reports and Dashboards

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"

SOX: Internal Controls for Accounts Payable

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.

Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data

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.

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.

Why EBITDA Doesn't Spell Cash Flow But What Does

Both lenders and borrowers like to to use EBITDA as proof of repayment ability, but as noted earlier, it overestimates repayment ability.

ChatGPT & Technical Writing use the Tool to Boost your Productivity and Writing Quality

This 60-minute webinar explores how ChatGPT can revolutionize technical writing by enhancing productivity, accuracy, and clarity in document creation.

1099 and W-9 Update - Complying with IRS Information Reporting

Complying with IRS information reporting requirements can be a complex and frustrating process-especially when it comes to Forms 1099 and W-9.

Excel - Dynamic Array Functions - A Game-changer in Formula Creation Overview

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.

Enterprise Risk Management: Balancing Risk Appetite and Risk Tolerance

In today's world of evolving technologies and businesses, financial organizations are taking on increasing levels of risk.

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.

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats

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.

ChatGPT for CPAs and Finance Professionals

Still unsure? Consider this: regulators are already discussing AI's implications for financial services.

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).

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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!

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"

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.

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.

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.

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.

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.

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.