- 8
- December
- 2023
- Friday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 8
- December
- 2023
- Friday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 11
- December
- 2023
- Monday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 11
- December
- 2023
- Monday
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.
Robert J. Russell |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 12
- December
- 2023
- Tuesday
FDA Good Meeting Practices Conducting Successful FDA Meetings
Virtually every medical device firm and pharmaceutical firm will need to meet with FDA as some time.
Larry Stevens |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 12
- December
- 2023
- Tuesday
6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities
This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.
Robert J. Russell |
Duration: 6 Hours |
Price: $545.00
| View Details
- 13
- December
- 2023
- Wednesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 13
- December
- 2023
- Wednesday
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. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 14
- December
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 15
- December
- 2023
- Friday
3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
Carolyn Troiano |
Duration: 3 Hours |
Price: $299.00
| View Details
- 15
- December
- 2023
- Friday
4-Hour Virtual Seminar on Mastering Excel Pivot Tables
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Dennis Taylor |
Duration: 4 Hours |
Price: $445.00
| View Details
- 18
- December
- 2023
- Monday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 19
- December
- 2023
- Tuesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 19
- December
- 2023
- Tuesday
6-Hour Virtual Seminar on Project Management for Non-Project Managers
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Charles H. Paul |
Duration: 6 Hours |
Price: $545.00
| View Details
- 19
- December
- 2023
- Tuesday
The Most Common Problems in FDA Software Validation & Verification
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
John E Lincoln |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 20
- December
- 2023
- Wednesday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 20
- December
- 2023
- Wednesday
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.
Robert J. Russell |
Duration: 3 Hours |
Price: $299.00
| View Details
- 20
- December
- 2023
- Wednesday
6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices, etc.)
This seminar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance.
Joy McElroy |
Duration: 6 Hours |
Price: $545.00
| View Details
- 21
- December
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 21
- December
- 2023
- Thursday
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.
Ginette Collazo |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 21
- December
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 21
- December
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 22
- December
- 2023
- Friday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 22
- December
- 2023
- Friday
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. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Carolyn Troiano |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 22
- December
- 2023
- Friday
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
Verification and validation requirements have always been part of the US FDA’s GMPs. Yet companies still struggle with the performance of and documentation of Equipment, Process, Software, and quality management system validations.
John E Lincoln |
Duration: 3 Hours |
Price: $299.00
| View Details
- 22
- December
- 2023
- Friday
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Mike Thomas |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 8
- January
- 2024
- Monday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 8
- January
- 2024
- Monday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 9
- January
- 2024
- Tuesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 10
- January
- 2024
- Wednesday
Project Management - Tasks Work Breakdown Structure Linking & Scheduling in MS Project
Understanding effective and accurate task management, durations, linking and scheduling are essential to start your projects correctly and minimise major adjustments, delays and cost impacts.
Ray Evans |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 10
- January
- 2024
- Wednesday
Beyond ESG: Quality for a Sustainable Future
As an introduction we point out how important sustainability is for the planet as a whole and how companies will be faced with increasing demands on their impact on society, in all aspects of the term.
Willy Vandenbrande |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 10
- January
- 2024
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 10
- January
- 2024
- Wednesday
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.
Robert J. Russell |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 11
- January
- 2024
- Thursday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 11
- January
- 2024
- Thursday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 12
- January
- 2024
- Friday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 12
- January
- 2024
- Friday
Excel - Mastering Lookup Functions
"How do I look up a value in list ONE and pick up a related value from list TWO"
Ray Evans |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 15
- January
- 2024
- Monday
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 |
Duration: 3 Hours |
Price: $299.00
| View Details
- 16
- January
- 2024
- Tuesday
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. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 16
- January
- 2024
- Tuesday
Learn the Dos and Don'ts of Opening Business Bank Accounts
It's about time we leverage the tools and resources to make us more effective and efficient. I’m talking about ChatGPT. As with any tools, there are pros and cons. We will discuss the background, understanding general concepts, the tools available and what the future may bring.
Justin Muscolino |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 16
- January
- 2024
- Tuesday
Pivot Table Essentials for Data Analytics in Excel
A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real time. This table empowers the user to view and analyze large amounts of information.
Ray Evans |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 16
- January
- 2024
- Tuesday
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.
Robert J. Russell |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 17
- January
- 2024
- Wednesday
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. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
John E Lincoln |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 17
- January
- 2024
- Wednesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 17
- January
- 2024
- Wednesday
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.
John C. Fetzer |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 17
- January
- 2024
- Wednesday
The Smile of the Nurse: Service Quality Improvement
Services make up some 75% of the overall economic activity. But this economic reality is not visible in quality management. Members of quality organizations are mainly from manufacturing, the language we use is production related and our tools are to a large extend directed at solving technical problems.
Willy Vandenbrande |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 18
- January
- 2024
- Thursday
Making your Excel Spreadsheet much Easier to use with Tables
Tables are a powerful Excel functionality to streamline many data management functions.
Ray Evans |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 19
- January
- 2024
- Friday
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?"
Mike Thomas |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 22
- January
- 2024
- Monday
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 22
- January
- 2024
- Monday
Effective (and FDA Accepted Responses) to FDA 483s and Warning Letters
If you work for any firm that manufactures products regulated by FDA, you very likely will experience an FDA inspection.
Larry Stevens |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 22
- January
- 2024
- Monday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 22
- January
- 2024
- Monday
Starting with Excel - The Vital Essentials
This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts
Ray Evans |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 22
- January
- 2024
- Monday
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.
Robert J. Russell |
Duration: 3 Hours |
Price: $299.00
| View Details
- 24
- January
- 2024
- Wednesday
Using Excel PivotTables to Easily Summarize and Analyze Data
The ability to analyze data is a powerful skill that helps make better decisions. Microsoft Excel is one of the top tools for data analysis and PivotTables are arguably the most popular analytic tool.
Ray Evans |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 24
- January
- 2024
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 24
- January
- 2024
- Wednesday
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.
Robert J. Russell |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 25
- January
- 2024
- Thursday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 26
- January
- 2024
- Friday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 26
- January
- 2024
- Friday
Macros In Excel - Automated Productivity & Time Savings
To gain a practical “hands-on” understanding of how to efficiently create, manage and run Macros in Excel.
Ray Evans |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 29
- January
- 2024
- Monday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 29
- January
- 2024
- Monday
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
Verification and validation requirements have always been part of the US FDA's GMPs. Yet companies still struggle with the performance of and documentation of Equipment, Process, Software, and quality management system validations.
John E Lincoln |
Duration: 3 Hours |
Price: $299.00
| View Details
- 30
- January
- 2024
- Tuesday
Regulatory Quarterly Update: Connecting Rules to Roles
In our current environment, Regulators have become more focused than ever to ensure financial institutions are operating with the consumer in mind.
Justin Muscolino |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 31
- January
- 2024
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 31
- January
- 2024
- Wednesday
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.
Ginette Collazo |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 31
- January
- 2024
- Wednesday
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 |
Duration: 60 Minutes |
Price: $149.00
| View Details
- 6
- February
- 2024
- Tuesday
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 |
Duration: 90 Minutes |
Price: $149.00
| View Details
- 7
- February
- 2024
- Wednesday
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
David Nettleton |
Duration: 75 Minutes |
Price: $149.00
| View Details
- 13
- March
- 2024
- Wednesday
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 |
Duration: 2 Hours |
Price: $199.00
| View Details
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