Test

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.

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.

4-Hour Virtual Seminar on Combination Product Device Supplier Management Training

There has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance.

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.

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.

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?"

2-Day Virtual Seminar on Technical Writing in the Life Sciences - Writing Regulatory Documentation for Consistency, Clarity, Accuracy, and Utility

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.

Excel Power Tools: Unlocking the Full Potential of What-If Analysis with Goal Seek, Solver, and Data Tables

Attending this webinar will equip you with practical skills to leverage Excel's powerful What If Analysis tools-Goal Seek, Solver, and Data Table.

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

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.

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.

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.

6-Hour Virtual Seminar on Project Management for Non-Project Managers

What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.

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.

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.

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.

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.

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.

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.

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.

4-Hour Virtual Seminar on ChatGPT for Project Management: From Basics to Advanced

Participants will want to attend this seminar to gain practical and actionable skills that will revolutionize their approach to project management.

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.

Enhancing Pivot Tables with Images: Visualize Your Data Like a Pro

Are you looking to elevate your Excel skills and create more engaging and visually appealing reports? Join our upcoming webinar, "Enhancing Data Visualization in Excel with Embedded Images in Pivot Tables, "where we will dive into one of the latest and most exciting features in Excel: the ability to embed images directly into Pivot Tables. This innovative functionality can transform your data presentation, making it more dynamic and easier to interpret.

How to Create an Effective and GMP - Compliant Training Program and Reduce Training - Related Human Errors

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

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. 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.

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.

Unleashing the Power of Excel: Exploring the Latest Regular Expressions (REGEX) Functions

As the volume of data we handle continues to grow exponentially, the ability to efficiently process and analyze text data becomes increasingly crucial.

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.

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

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

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.

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.

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.

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.

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"

FDA Regulation of Artificial Intelligence/ Machine Learning

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

6-Hour Virtual Seminar on GCP/GLP/GMP: Comparison and Understanding of the FDA's 3 Major Regulations

The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products.

4-Hour Virtual Seminar on The Project Management Course: Beginner to Project Manager

It is not possible to present a complete treatment of project management in the span of 4-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.

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.

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.

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.

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.

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.

Trends in FDA Compliance and Enforcement for Regulated Systems

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.

Understanding 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.

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.

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.

Outlook Email Calendar & Contacts Essentials Masterclass

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

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.

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.

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.

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, and communication, among many others, will be discussed as part of this webinar.

6-Hour Virtual Seminar on FDA Audit Preparation, Inspection Conduct, and Do's and Don'ts

This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.

3-Hour Virtual Seminar on IQ, OQ, and PQ in the Verification and Validation Process

Validation is an important element of the Quality System Regulations and ISO13485.

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 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.

Excel - Mastering Lookup Functions

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

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.

3-Hour Virtual Seminar on Bootcamp on Quality Management System (QMS) - Per ISO and US FDA's GMPs

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

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.

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.

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 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.

ChatGPT & AI for Project Management for FDA-Regulated Companies

This 90-minute webinar is designed to provide project management professionals with comprehensive insights into the practical applications of AI tools like ChatGPT.

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.

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.

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.

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.

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.

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.

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.

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.

How to Reduce Human Error in a GMP Manufacturing/Floor

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

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.

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.

Quality Management 101: An Enterprise Maintenance Professional's Guide

What 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 international standard for Quality Management Systems for all business or industrial systems worldwide.

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.

3-Hour Virtual Seminar on Chat GPT for Project Management in FDA Regulated Environment

This comprehensive three-hour virtual seminar, titled "Mastering AI Integration in Project Management: Leveraging ChatGPT for Enhanced Efficiency and Compliance in FDA-Regulated Industries," is designed to provide project management professionals with a thorough understanding of the practical applications of AI tools like ChatGPT.

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.

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.

2-Day Virtual Seminar on Project Management for Non-Project Managers - PM in the Life Sciences - Pharmaceutical/ Biotechnology and Medical Devices

What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.

Excel - 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.

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.

Excel Formula Functions & Automatic Calculation Powerpoint Easy

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

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.

Excel - 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.

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.

FDA Regulation of Artificial Intelligence/ Machine Learning

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

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.

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.

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.

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.

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

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.

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.

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.

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.

How to Deal with Bad Results Under GLP

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

Excel - Mastering Lookup Functions

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

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.

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.

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.

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.

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.

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.

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?"

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.

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.

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.

FDA Regulation of Artificial Intelligence/ Machine Learning

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

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.

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.

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and the Future

One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.

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.

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.

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 Deal with Bad Results Under GLP

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

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.

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats

This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.

Human 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.