Test

Role of Cognitive Load in Medical Device Design and Human Error Prevention

The webinar delves into the critical nexus between healthcare technology and user performance. The 90-minute session begins with an exploration of cognitive load, dissecting its intrinsic, extraneous, and germane components

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.

Regulation Update Q1 2024: New and Proposed Regulations for Financial Institutions

In our current environment, Regulators have become more focused than ever to ensure financial institutions are operating with the consumer in mind.

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

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. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.

Human Factors Engineering in Medical Device Design

This 90-minute webinar will delve into the fundamental aspects of HFE, emphasizing its pivotal role in enhancing safety, efficiency, and overall user experience within the medical device landscape.

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.

ChatGPT for Excel Essentials Made Easy

Mastering AI is now a fundamental and highly marketable skill set in Excel and is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.

The Monte Carlo Simulations in Excel for Risky Investments

This workshop is about understanding what is behind the Monte Carlo Simulation.

Assess Impact for Supplier Change Notices

This webinar will present strategies and tools for doing a complete and comprehensive impact assessment of supplier change notices.

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

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

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.

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.

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. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

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.

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.

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

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

Design Control for Medical Devices: Overview and Design Inputs

Verification and validation of design inputs is a critical step in the development of medical devices.

Excel - Essential Tips and Tricks for the New User

Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.

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

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

Optimizing Efficiency: A Comprehensive Guide to 5S Principles

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

Enhancing Compliance Officers Capabilities

Since Compliance Officers have direct contact with all parts of the business, it's essential that they have the necessary tools to succeed and help shift the compliance culture of an organization.

4-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.

Training Strategies to Reduce Human Error in Drug Manufacturing

The webinar on offers a comprehensive exploration of the pivotal strategies aimed at minimizing errors in one of the most critical sectors of the pharmaceutical industry. The introductory segment sets the stage by emphasizing the paramount importance of error reduction in drug manufacturing for ensuring product safety, efficacy, and regulatory compliance.

GDPR - How to Protect Your Organization

Data protection and privacy is an important issue this day and age for the public.

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 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.

FDA Regulation of Artificial Intelligence/ Machine Learning

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

Design Control for Medical Devices Including Verification/Validation

Verification and validation of design inputs is a critical step in the development of medical devices.

ChatGPT for Excel Intermediate Masterclass

This easy to follow demonstration clearly explains how to effectively post ChatGPT questions on more advanced Excel topics and extract more accurate responses.

Excel - A Beginner's Guide to Formulas

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

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.

The Data Ribbon and PivotTables

The purpose of this workshop is to use the features of the data ribbon and the PivotTable of Excel for what we call datamining.

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.

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. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

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.

How to Deal with Bad Results Under GLP

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

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 it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Human Error Risk Management in Medical Device Design

The topic delves into the critical interplay between human factors, design processes, and patient safety within the realm of healthcare technology. It begins by elucidating the multifaceted nature of human errors, encompassing cognitive, perceptual, and physical aspects, and underscores their potential impact on patient well-being.

How to Prepare for and Conduct a Regulatory Audit

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.

Powerpoint Creating & Presenting A Complete Slide Show

From animations and video, through to organisation charts and process flows, PowerPoint is your complete presentation graphics package providing everything you need for communicating information in an engaging and professional format.

Excel - Lists and Tables - A Beginner's Guide to Managing List-Based Data

Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.

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.

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

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

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).

FDA Best Audit Practices - Do's And Don'ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

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

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

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

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.

21 CFR Part 11 - Compliance for Electronic Records and Signatures

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

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.

Post-Market Surveillance and Project Management Ensuring Long-term Success

This 90-minute webinar delves into the critical intersection of post-market surveillance and project management, providing professionals across industries with comprehensive insights into ensuring long-term success.

Excel Formulas Functions & Automatic Calculation Made Easy

Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.

Controlling Human Error in the Manufacturing Floor

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

Introduction to Excel's Built-in Solver - Advanced Decision-Making Tools

Solver is a Microsoft Excel add-in program you can use for what-if analysis. Use Solver to find an optimal (maximum or minimum) value for a formula in one cell - called the objective cell - subject to constraints, or limits, on the values of other formula cells on a worksheet.

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.

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.

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

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

Excel 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.

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today's world, there are a ton of data to manage. Data is coming from many different sources.

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.

Impact Assessment and Risk Management for Change Control

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

Regulation Update Q1 2024: New and Proposed Regulations for Financial Institutions

In our current environment, Regulators have become more focused than ever to ensure financial institutions are operating with the consumer in mind.

Excel - A Beginner's Guide to Formulas

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

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.

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).

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.

Cybersecurity in Medical Device Technology

Many companies don't even think about the TPP until they are writing the BLA; by then it has exhausted its useful life.

Outlook Email Calendar & Contacts Essentials Masterclass

Microsoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.

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.

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.

How to Write SOPs for Human Error Reduction

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

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.

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

Advancements in technology have forced organizations to rethink business models.

Assess Impact for Supplier Change Notices

This webinar will present strategies and tools for doing a complete and comprehensive impact assessment of supplier change notices.

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. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.

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.

Enhancing Compliance Officers Capabilities

Since Compliance Officers have direct contact with all parts of the business, it's essential that they have the necessary tools to succeed and help shift the compliance culture of an organization.

Value Stream Mapping

This webinar will begin by defining value stream mapping and the key terms that comprise the VSM process.

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.

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.

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.

User-Centered Design in Drug and Medical Device Development

This 90-minute webinar offers a comprehensive exploration of the fundamental principles and practical applications of user-centered design (UCD) within the realm of pharmaceuticals and medical device development.

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

ChatGPT for Excel Essentials Made Easy

Mastering AI is now a fundamental and highly marketable skill set in Excel and is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.

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. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.

Introduction to Microsoft Power BI Dashboards

Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Demystified: Transforming Data into Stunning Visuals"

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.

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.

GDPR - How to Protect Your Organization

Data protection and privacy is an important issue this day and age for the public.

5S for Operators and Human Error Reduction

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

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.

Design Control for Medical Devices: Overview and Design Inputs

Verification and validation of design inputs is a critical step in the development of medical devices.

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.

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

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

Excel - Essential Tips and Tricks for the New User

Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.

Design Control for Medical Devices Including Verification/Validation

Verification and validation of design inputs is a critical step in the development of medical devices.

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.

2-Hour Virtual Seminar on Reduce Performance Failures in Your Operations by Addressing Human Performance, Human Error, and Cognitive Effort

In today's fast-paced operational environments, organizations face challenges related to human performance, human error, and mental load. This comprehensive two-hour training program aims to equip participants with the knowledge, skills, and strategies to reduce performance failures in operations.

ChatGPT for Excel

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

FDA Regulation of Artificial Intelligence/ Machine Learning

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

Excel - Lists and Tables - A Beginner's Guide to Managing List-Based Data

Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.

How to Reduce Human Error in a GMP Manufacturing/Floor

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

4-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.

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.

How to Prepare for and Conduct a Regulatory Audit

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.

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.

Excel - Build Advanced Pivot Table Solutions Using the Data Model & PowerPivot

Your data is only as good as the information you can derive from it. Power Pivot enables you to gain better business insights and make more informed business decisions.

How to Deal with Bad Results Under GLP

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

ChatGPT for Excel Intermediate Masterclass

This easy to follow demonstration clearly explains how to effectively post ChatGPT questions on more advanced Excel topics and extract more accurate responses.

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. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

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.

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.

Project Management Scheduling Your Project

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

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?

Excel - Build Even More Powerful Pivot Tables: DAX Essentials

In today's data-driven world, having a strong command of Excel is essential, and understanding the Data Analysis Expressions (DAX) formula language is the key to unlocking the true potential of Excel's Power Pivot and Data Model features.

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today's world, there are a ton of data to manage. Data is coming from many different sources.

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

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.

Project Management - Monitoring and Controlling Your Project

This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.

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.

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.

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.

Fair Debt Collection Practices Act (FDCPA)

During this webinar, Justin will discuss an overview of the FDCPA, history, provisions, recent updates and how it came about. Also, how FDCPA relates to all levels of staff. We will also discuss the current regulatory & economic environment to help us determine what 2024 could look like.

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.

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.

Introduction to Microsoft Power BI Dashboards

Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Demystified: Transforming Data into Stunning Visuals"

21 CFR Part 11 - Compliance for Electronic Records and Signatures

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

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).

Data Integrity and Human Error

Data integrity refers to the accuracy, completeness, and consistency of data over its entire lifecycle.

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.

ChatGPT & AI for Project Management

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

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.

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.

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. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.

Excel Pivot Tables, Pivot Charts, Slicers, and Timelines

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

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.

ChatGPT and Project Management: Leveraging AI for Project Management Excellence

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

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

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.

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.

Digital Assets & The Associated Compliance Risks

We must be aware of the compliance risks that are relevant with digital assets, specifically, cryptocurrencies.

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. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.

Cybersecurity Challenges in Medical Device Technology

Many companies don't even think about the TPP until they are writing the BLA; by then it has exhausted its useful life.

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.

Strategic Error Mitigation: Standard Operating Procedures for Human Error Reduction

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

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 Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.

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.

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.

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.

Pharma 4.0 Focus - Newer Approaches and Technologies to Reduce Costs while Complying with FDA's 21 CFR Part 11, Data Integrity

FDA's recent focus on 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.

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.

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.

Excel - Quick Tips to Help You Be More Productive

Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"

ChatGPT for Excel

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

Project Management for Non-Project Managers - Scheduling your Project

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

Project Management for Computer System Validation (CSV) to Improve FDA Compliance

We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities by applying a sound, project management approach. Each validation effort includes a vast set of activities and tasks required to get the job done. These can be managed more effectively by better understanding how to apply a project management approach to them all, regardless of size.

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

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.

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.

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.

FDA Regulation of Artificial Intelligence/ Machine Learning

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

Building GMP Excellence: A Guide to Implementing Compliant Training Programs

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

Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance

In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended.

Excel - A Beginner's Guide to Formulas

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

Enhancing Compliance Officers Capabilities

Since Compliance Officers have direct contact with all parts of the business, it's essential that they have the necessary tools to succeed and help shift the compliance culture of an organization.

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.

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

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. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

4-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.

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.

How to Deal with Bad Results Under GLP

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

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.

Supervising a Human Error-Free Environment: You can do a Lot More than you Think

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.

Excel - Essential Tips and Tricks for the New User

Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.

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.

Risk-Based Validation of Spreadsheet Applications

We will explore the best practices and strategic approach for evaluating Excel spreadsheets 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.