• 17
  • May
  • 2024
  • Friday
11:30 AM PDT | 02:30 PM EDT

ChatGPT for Excel Essentials Made Easy

Gain easy-to-understand and practical "hands-on" knowledge of ChatGPT and Artificial Intelligence (AI) with a focus on significantly enhancing capabilities in Microsoft Excel.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 17
  • May
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

Strategies To Prevent 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.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 17
  • May
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 20
  • May
  • 2024
  • Monday
12:00 PM PDT | 03:00 PM EDT

AI For Excel: Empowering Excel With ChatGPT And Other AI Tools

This course is designed to teach learners how to use CHATGPT and other AI tools 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

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • May
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 3 Hours | Price: $299.00 | View Details
  • 20 & 21
  • May
  • 2024
  • Monday
08:00 AM PDT | 11:00 AM EDT

2-Day 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. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

Charles H. Paul Charles H. Paul | Duration: 2 Days | Price: $995.00 | View Details
  • 21
  • May
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 21
  • May
  • 2024
  • Tuesday
11:30 AM PDT | 02:30 PM EDT

ChatGPT for Excel Intermediate Masterclass

Harness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 22
  • May
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 90 Minutes | Price: $149.00 | View Details
  • 22
  • May
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Human Error Gen- Human Error Mitigation: Strategies for Enhanced Performance

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 22
  • May
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 22
  • May
  • 2024
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

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

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

John E Lincoln John E Lincoln | Duration: 3 Hours | Price: $299.00 | View Details
  • 22
  • May
  • 2024
  • Wednesday
09:00 AM PDT | 12:00 PM EDT

AML Regulations 2024

It’s important to understand these changes, but we must also understand the implications for our financial institutions, particularly for individual staff members. This webinar will provide you the recent updates, relevant personnel impacted, and thoughts on updates to your internal documents.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $149.00 | View Details
  • 23
  • May
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

FDA Regulation of Artificial Intelligence/ Machine Learning

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

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 23
  • May
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 24
  • May
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

Consumer Food and Health Attitudes 2024-2025

If your businee or industy addresses the needs of the consumer health, wellness, and food industries, this is a must see event.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 24
  • May
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 24
  • May
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 24
  • May
  • 2024
  • Friday
08:00 AM PDT | 11:00 AM EDT

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

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

Carolyn Troiano Carolyn Troiano | Duration: 4 Hours | Price: $445.00 | View Details
  • 27
  • May
  • 2024
  • Monday
09:00 AM PDT | 12:00 PM EDT

3-Hours 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. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

Carolyn Troiano Carolyn Troiano | Duration: 3 Hours | Price: $299.00 | View Details
  • 27
  • May
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 28
  • May
  • 2024
  • Tuesday
12:00 PM PDT | 03:00 PM EDT

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

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 28
  • May
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 29
  • May
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 29
  • May
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

How to Deal with Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 30
  • May
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

How to Write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOPs to reduce the likelihood of human errors.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 30
  • May
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

ChatGPT for Innovative Business Advisory Services for Accountants

The course provides a concise overview of how accounting professionals can leverage ChatGPT, OpenAI's powerful language model, to innovate and enhance their business advisory services. In plain language the presentation integrates theory and practice, and demonstrates how various enterprise evaluation methodologies can be applied in combination with ChatGPT to sharpen your business analysis and increase your organization’s efficiency, profitability, and growth

Garrett Wasny Garrett Wasny | Duration: 60 Minutes | Price: $149.00 | View Details
  • 31
  • May
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

Excel & ChatGPT Synergy Masterclass: Unleashing Financial Analysis Superpowers

In today's data-driven landscape, the fusion of Excel's computational might with ChatGPT's intelligent querying transforms ordinary accounting tasks into dynamic, insightful financial analyses. This specialized masterclass unveils the power behind integrating Excel and ChatGPT, aimed at accountants, financial analysts, and business professionals eager to unlock new levels of efficiency and creativity in their financial workflows.

Garrett Wasny Garrett Wasny | Duration: 90 Minutes | Price: $149.00 | View Details
  • 31
  • May
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 31
  • May
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 31
  • May
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 31
  • May
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 31
  • May
  • 2024
  • Friday
09:00 AM PDT | 12:00 PM EDT

Artificial Intelligence (AI) and Fraud: Exploring Risks and Opportunities

With AI, we need to understand the risks and opportunities it presents. The risk can be high, but prevention is the key. With every technology, there can be element of good and evil. Within financial services. AI can be applied to identify unusual activity, show inconsistent data, remove manual efforts, improve collaboration, and offer a quick and efficient means to review vast amounts of information.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $149.00 | View Details
  • 3
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 3
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 4
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.

Roger Cowan Roger Cowan | Duration: 60 Minutes | Price: $149.00 | View Details
  • 4
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 4
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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

This 2-Hour Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

David Nettleton David Nettleton | Duration: 2 Hours | Price: $199.00 | View Details
  • 4
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 5
  • June
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 5
  • June
  • 2024
  • Wednesday
12:00 PM PDT | 03:00 PM EDT

Excel PowerPivot and Power Query

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.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 5
  • June
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 6
  • June
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Strategic Error Mitigation: Standard Operating Procedures for 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

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 7
  • June
  • 2024
  • Friday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Carolyn Troiano Carolyn Troiano | Duration: 6 Hours | Price: $545.00 | View Details
  • 7
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

Performance of Root Cause Analysis, CAPA, and Effectiveness Checks

This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks.

Meredith Crabtree Meredith Crabtree | Duration: 90 Minutes | Price: $149.00 | View Details
  • 7
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Michael Esposito Michael Esposito | Duration: 60 Minutes | Price: $149.00 | View Details
  • 7
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

Introduction to Generative AI for Accountants

This course offers an in-depth look into Generative AI and its transformative impact on the accounting profession. At the core of Generative AI are technologies that can literally "see, speak, hear, write, and create" in multimodal contexts.

Garrett Wasny Garrett Wasny | Duration: 90 Minutes | Price: $149.00 | View Details
  • 7
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 7
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

QMS 101: Quality Management System Guide

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

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 10
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 10
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 10
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 10
  • June
  • 2024
  • Monday
08:00 AM PDT | 11:00 AM EDT

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. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.

Tom Fragale Tom Fragale | Duration: 4 Hours | Price: $445.00 | View Details
  • 11
  • June
  • 2024
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

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

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

John E Lincoln John E Lincoln | Duration: 3 Hours | Price: $299.00 | View Details
  • 11
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

How to Write SOPs that Avoid Human Error

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

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 12
  • June
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

SOPs - How to Write Them to Satisfy Those Inspectors

Attending this training will help the participant understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance.

Meredith Crabtree Meredith Crabtree | Duration: 90 Minutes | Price: $149.00 | View Details
  • 12
  • June
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

How Accountants Can Use Chat GPT 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.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $149.00 | View Details
  • 12
  • June
  • 2024
  • Wednesday
12:00 PM PDT | 03:00 PM EDT

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.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 12
  • June
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 13
  • June
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 14
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

Strategies To Prevent 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.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 14
  • June
  • 2024
  • Friday
12:00 PM PDT | 03:00 PM EDT

Excel: Tips and Tricks and Shortcuts

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

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 17
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 3 Hours | Price: $299.00 | View Details
  • 17
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

Understanding 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.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $149.00 | View Details
  • 17
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 17
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Value Stream Mapping

This webinar will begin by defining value stream mapping and the key terms that comprise the VSM process. The purpose of VSM, important to participant focus, will also be discussed.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 18
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Human Error Reduction Techniques for Floor Supervisors

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

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 18
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Power BI Demystified: Transforming Data into Stunning Visuals

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”

Mike Thomas Mike Thomas | Duration: 90 Minutes | Price: $149.00 | View Details
  • 18
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 19
  • June
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA

“From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA” is a comprehensive training session designed to provide participants with an understanding of the role of the Food and Drug Administration (FDA) in regulating dietary supplements.

Meredith Crabtree Meredith Crabtree | Duration: 90 Minutes | Price: $149.00 | View Details
  • 19
  • June
  • 2024
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

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

Carolyn Troiano Carolyn Troiano | Duration: 4 Hours | Price: $445.00 | View Details
  • 19
  • June
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

FDA Regulation of Artificial Intelligence/ Machine Learning

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

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • June
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Bank Enforcement Actions 2024: What happened and what Can We Learn

We will go through the different banking regulators and discuss recent enforcement actions. The goal of this training is to take away the lessons learned by prior enforcement actions, implementing changes within your compliance framework, continue with your risk mitigation efforts and manage your reputational risk when similar issues arise.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $149.00 | View Details
  • 21
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 21
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 21
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 21
  • June
  • 2024
  • Friday
12:00 PM PDT | 03:00 PM EDT

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.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 24
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 24
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 24
  • June
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 25
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 25
  • June
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Digital Assets & The Associated Compliance Risks

We must be aware of the compliance risks that are relevant with digital assets, specifically, cryptocurrencies. This regulatory landscape for cryptocurrencies is starting to move in the right direction and we could see some drastic movement in 2024. Justin will go through the recent developments to help you prepare in 2024

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $149.00 | View Details
  • 26
  • June
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • June
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

How to Deal with Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 26
  • June
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 27
  • June
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Excel - Mastering Lookup Functions

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

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 27
  • June
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 27
  • June
  • 2024
  • Thursday
09:00 AM PDT | 12:00 PM EDT

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.

Justin Muscolino Justin Muscolino | Duration: 60 Minutes | Price: $149.00 | View Details
  • 28
  • June
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

Quality Management Do's and Don't's

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

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 28
  • June
  • 2024
  • Friday
08:00 AM PDT | 11:00 AM EDT

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.

Tom Fragale Tom Fragale | Duration: 4 Hours | Price: $445.00 | View Details
  • 3
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 8
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 9
  • July
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Understanding How Quality Management Works

Whar are the basics of a Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 9
  • July
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Project Management for Non-Project Managers - How to Effectively Monitor and Control Your Project

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

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 10
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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

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

David Nettleton David Nettleton | Duration: 90 Minutes | Price: $149.00 | View Details
  • 11
  • July
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 12
  • July
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

Project Management for Non-Project Managers - Determining the Work that needs to be done

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

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 15
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 15
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 18
  • July
  • 2024
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that can erect obstacles to understanding the information and intent of the communications sent and received.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 19
  • July
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 3 Hours | Price: $299.00 | View Details
  • 22
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 23
  • July
  • 2024
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on Quality Management Bootcamp

Whar are the basics of a Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001.

John E Lincoln John E Lincoln | Duration: 3 Hours | Price: $299.00 | View Details
  • 26
  • July
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • July
  • 2024
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 29
  • July
  • 2024
  • Monday
10:00 AM PDT | 01:00 PM EDT

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

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 31
  • July
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 7
  • August
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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

This interactive webinar provides explicit details and a live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP-compliant spreadsheet application.

David Nettleton David Nettleton | Duration: 75 Minutes | Price: $149.00 | View Details
  • 14
  • August
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Quality Management 101: Enterprise Maintenance Professional's Guide

Whar are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the internatioinal standard for Quality Management Systems for all business or industrial systems worldwide.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 11
  • September
  • 2024
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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

This 2-Hour Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

David Nettleton David Nettleton | Duration: 2 Hours | Price: $199.00 | View Details
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