This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be dealt with at all levels to make sure the end product being used by a patient or consumer is perfectly safe and delivers the effective treatment required
Carolyn Troiano | Duration: 90 Minutes | Price: ¤150.00 | View DetailsMicrosoft Excel has become the de facto spreadsheet application for business.
Tom Fragale | Duration: 60 Minutes | Price: ¤150.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, on a social media platform.
Casper Uldriks | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThis 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: ¤150.00 | View DetailsWhat 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. You are half listening to the presentation while thinking about some of the other work you need to complete on different matters. The installation will take a year to execute and will require the coordination with several functions inside and outside of the company.
Charles H. Paul | Duration: 6 Hours | Price: ¤545.00 | View DetailsUpon 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 DetailsThis 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsIn 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: ¤150.00 | View DetailsExcel 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: 60 Minutes | Price: ¤150.00 | View DetailsIf 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 | Duration: 60 Minutes | Price: ¤150.00 | View DetailsValidation is an important element of the Quality System Regulations and ISO13485.
Susanne Manz | Duration: 90 Minutes | Price: ¤150.00 | View DetailsPlan and initiate your projects with confidence, knowledge and consistency.
Ray Evans | Duration: 90 Minutes | Price: ¤150.00 | View DetailsServices 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: 60 Minutes | Price: ¤150.00 | View DetailsHuman 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: ¤150.00 | View DetailsAttending 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThe US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post-production risk management program to be implemented.
Edwin Waldbusser | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThis webinar will begin with an explanation of the process and how it originally conflicted with all regulatory bodies worldwide and how it now can be applied, with minor adjustments, to counter those original difficulties. The webinar will also discuss when the process should be used, how it should be staffed, and the process for its use.
Charles H. Paul | Duration: 90 Minutes | Price: ¤150.00 | View DetailsFDA steadily expands the scope and restrictions for the promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume you're talking to FDA.
Casper Uldriks | Duration: 3 Hours | Price: ¤290.00 | View DetailsIt'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: ¤150.00 | View DetailsIt 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: ¤150.00 | View DetailsThis 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThis webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Charles H. Paul | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThis webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Susanne Manz | Duration: 90 Minutes | Price: ¤150.00 | View DetailsRevolutionize the way you communicate data with this cutting-edge training on Excel visual storytelling. Discover the power of visual data representation to transform complex numerical information into compelling, insightful visual narratives
Mike Thomas | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThere has been a major shift in the emphasis of U.S. FDA CGMP compliance audits over the past few years.
John E Lincoln | Duration: 6 Hours | Price: ¤545.00 | View DetailsAI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser | Duration: 60 Minutes | Price: ¤150.00 | View DetailsMicrosoft Outlook is the powerhouse in managing email, appointments, tasks and contacts.
Ray Evans | Duration: 90 Minutes | Price: ¤150.00 | View DetailsIf you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Casper Uldriks | Duration: 6 Hours | Price: ¤545.00 | View DetailsInstrumental 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: ¤150.00 | View DetailsMicrosoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Dennis Taylor | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThe feeling is sometimes created that technology itself leads the waves of change.
Willy Vandenbrande | Duration: 75 Minutes | Price: ¤150.00 | View DetailsAlthough 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: ¤150.00 | View DetailsHuman error is known to be the major cause of quality and production losses in many industries.
Ginette Collazo | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThis 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 | Duration: 6 Hours | Price: ¤545.00 | View DetailsFDA requires that all software in computer systems used in GxP activities must be validated. The validation of computer system software is completely different from than validation of device software (embedded software). Validation is much more than testing. It is testing plus design control and configuration management.
Edwin Waldbusser | Duration: 60 Minutes | Price: ¤150.00 | View DetailsWe will explore the latest best industry practices offered in GAMP®5 (Second Edition) and understand what it offers to those validation computer systems in the FDA-regulated industries. We will cover the changes and impact on validation as a result. We will also cover FDA’s recent draft guidance on Computer Software Assurance (CSA) and what that means in terms of how to approach validation.
Carolyn Troiano | Duration: 90 Minutes | Price: ¤150.00 | View DetailsGoing “beyond the basics” Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.
Ray Evans | Duration: 90 Minutes | Price: ¤150.00 | View DetailsIf 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: ¤150.00 | View DetailsIn 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: ¤150.00 | View DetailsValidation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You'll learn about what processes need to be validated and what steps you need to take to validate processes.
Susanne Manz | Duration: 3 Hours | Price: ¤290.00 | View DetailsThe 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.
John E Lincoln | Duration: 6 Hours | Price: ¤545.00 | View DetailsScientific Writing Fundamentals - Mastering the Basics in Life Sciences Documentation is a dynamic and comprehensive 90-minute webinar designed to empower researchers, students, and professionals in the life sciences field with essential skills for effective written communication.
Charles H. Paul | Duration: 90 Minutes | Price: ¤150.00 | View DetailsAn 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: ¤290.00 | View DetailsFDA'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. These include all systems that "touch" product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.
Carolyn Troiano | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThis 90-minute webinar is designed to provide professionals across various industries with a comprehensive understanding of the critical intersection between effective technical writing, regulatory compliance, and copyright considerations.
Charles H. Paul | Duration: 90 Minutes | Price: ¤150.00 | View DetailsHuman 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsIf 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: ¤150.00 | View DetailsThe company must establish a program where they identify, analyze and control cybersecurity risks for both pre-market and post-market. The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to devise users.
Edwin Waldbusser | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThis 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: ¤150.00 | View DetailsFew 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: ¤150.00 | View DetailsUltimately costing principles, such as the causality principle, must be converted into practical practices with supporting tools.
Gary Cokins | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThis 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: ¤150.00 | View DetailsGain 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThis training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
John C. Fetzer | Duration: 60 Minutes | Price: ¤150.00 | View DetailsChatGPT 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: ¤150.00 | View DetailsWhat 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. You are half listening to the presentation while thinking about some of the other work you need to complete on different matters. The installation will take a year to execute and will require the coordination with several functions inside and outside of the company.
Charles H. Paul | Duration: 2 Days | Price: ¤995.00 | View DetailsAn often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"
Mike Thomas | Duration: 90 Minutes | Price: ¤150.00 | View DetailsHuman 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: ¤150.00 | View DetailsThere 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: ¤150.00 | View DetailsMastering AI Governance: Leading the Way Responsibly
Dr. Kimberly N. West | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThis 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: ¤150.00 | View DetailsThis 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: ¤150.00 | View DetailsChatGPT 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: ¤150.00 | View DetailsThis 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Carolyn Troiano | Duration: 90 Minutes | Price: ¤150.00 | View DetailsElevate your Excel prowess with this training. Aimed at users already versed in Excel's core functions (SUM, X/VLOOKUP, COUNTIF etc), this course introduces users to some of the new innovative functions added since 2020, exclusively available to Microsoft 365 and Excel 2021 users
Mike Thomas | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThis targeted 60-minute U.S. Reimbursement training/webinar will help you understand and navigate the complex U.S. system for understanding product reimbursement status and potential for your Medical Device.
Robert J. Russell | Duration: 60 Minutes | Price: ¤150.00 | View DetailsIn 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: ¤150.00 | View DetailsHarness the awesome power of AI to take Excel to a new level and boost your efficiency working smarter and faster.
Ray Evans | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThis 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.
Charles H. Paul | Duration: 6 Hours | Price: ¤545.00 | View DetailsThis ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).
Robert J. Russell | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThis 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. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.
Edwin Waldbusser | Duration: 60 Minutes | Price: ¤150.00 | View DetailsSupervision 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: ¤150.00 | View DetailsPeople and communications skills are very important in dealing with customers, but have little connection to doing good lab work. This webinar points out some approaches and skills to connect the two areas.
John C. Fetzer | Duration: 60 Minutes | Price: ¤150.00 | View DetailsWe 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsGlobal Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
Robert J. Russell | Duration: 4 Hours | Price: ¤445.00 | View Details"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: ¤150.00 | View DetailsExecutive management of many new virtual/small companies may have little to no prior biopharmaceutical industry experience; sometimes they do not have any pharma background at all.
Arvilla Trag | Duration: 60 Minutes | Price: ¤150.00 | View DetailsAI for Project Managers: Boost Your Skills and Supercharge Your Projects
Dr. Kimberly N. West | Duration: 60 Minutes | Price: ¤150.00 | View DetailsIn 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: ¤150.00 | View DetailsSince Compliance Officers have direct contact with all parts of the business, it's essential that they have the necessary tools to succeed and help shift the compliance culture of an organization.
Justin Muscolino | Duration: 60 Minutes | Price: ¤150.00 | View DetailsHuman 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: ¤150.00 | View DetailsThis 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsCompanies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).
Carolyn Troiano | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThe 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: ¤150.00 | View DetailsVirtually every medical device firm and pharmaceutical firm will need to meet with FDA as some time. To be prepared for these meetings and know how to handle them can be critical to the success of your business.
Larry Stevens | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThis 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: ¤150.00 | View DetailsBecome an Excel Hero in your organization! Make yourself indispensable. If these are your goals, having a good understanding of Excel's Logic functions is critical. It will help you with scenarios like these:
Mike Thomas | Duration: 60 Minutes | Price: ¤150.00 | View DetailsAI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThis 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsAssessment 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: ¤150.00 | View DetailsAs 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. We also give a brief overview of how sustainability has been wrongly tackled in the past.
Willy Vandenbrande | Duration: 75 Minutes | Price: ¤150.00 | View DetailsIn 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. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.
Carolyn Troiano | Duration: 90 Minutes | Price: ¤150.00 | View DetailsHuman error is known to be the primary cause of quality and production losses in many industries.
Ginette Collazo | Duration: 90 Minutes | Price: ¤150.00 | View DetailsIn today's digital world, artificial intelligence (AI) is making waves in education. But with all the talk of AI-powered this and AI-powered that, you might be wondering, "What does that even mean for me as a teacher?"
Dr. Kimberly N. West | Duration: 90 Minutes | Price: ¤150.00 | View DetailsMost companies have no idea what a TPP (Target Product Profile) is and what it is not, or how and when to use it.
Arvilla Trag | Duration: 60 Minutes | Price: ¤150.00 | View DetailsEmbark 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 | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThis 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: ¤290.00 | View DetailsSince Compliance Officers have direct contact with all parts of the business, it’s essential that they have the necessary tools to succeed and help shift the compliance culture of an organization. This webinar is geared towards Compliance Officers in an organization that deal with internal stakeholders. We will discuss ways to train compliances officers effectively and how to go about it.
Justin Muscolino | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThis session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.
Carolyn Troiano | Duration: 90 Minutes | Price: ¤150.00 | View DetailsMicrosoft Excel has become the de facto spreadsheet application for business.
Tom Fragale | Duration: 60 Minutes | Price: ¤150.00 | View DetailsFDA 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 | Duration: 3 Hours | Price: ¤290.00 | View DetailsThis 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: ¤150.00 | View DetailsThis webinar will describe the nature of human error in terms of how it is manifest and it distinct properties. As human error is directly related to human performance, we must discuss the contribution human performance has upon the inherent error that is performed by workers in life science settings. The impact of human error in manufacturing will be examined as a prelude to the discussion of human error investigation and root cause determination.
Charles H. Paul | Duration: 90 Minutes | Price: ¤150.00 | View DetailsAdvancements in technology have forced organizations to rethink business models.
Carolyn Troiano | Duration: 90 Minutes | Price: ¤150.00 | View DetailsHuman 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: ¤150.00 | View DetailsThis webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process.
Edwin Waldbusser | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThis course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Robert J. Russell | Duration: 6 Hours | Price: ¤545.00 | View DetailsThis course will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. ISO 13485 has almost identical requirements. Such a program will also help to get projects completed on time and within budget.
Edwin Waldbusser | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThis 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsExcel 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 | Duration: 60 Minutes | Price: ¤150.00 | View DetailsAdvancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
Carolyn Troiano | Duration: 90 Minutes | Price: ¤150.00 | View DetailsIn 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: ¤150.00 | View DetailsThis course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
John E Lincoln | Duration: 6 Hours | Price: ¤545.00 | View DetailsOften 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.
Mike Thomas | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThis 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: ¤150.00 | View Details"Regulatory agencies require that companies carefully select suppliers and contract manufacturers. The responsibility for product quality and safety remains with the company. It cannot be delegated to the CMO"
Edwin Waldbusser | Duration: 60 Minutes | Price: ¤150.00 | View DetailsHuman 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: ¤150.00 | View Details“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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThe course provides a concise overview of how accountants can use ChatGPT to assist with communications involving intricate and often sensitive topics that require a deep understanding of both financial principles and human resource policies. These conversations can range from budgeting and compensation to ethical considerations and regulatory compliance.
Garrett Wasny | Duration: 60 Minutes | Price: ¤150.00 | View Details"How do I look up a value in list ONE and pick up a related value from list TWO"
Mike Thomas | Duration: 60 Minutes | Price: ¤150.00 | View DetailsData integrity refers to the accuracy, completeness, and consistency of data over its entire lifecycle.
Ginette Collazo | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThis 90-minute course offers a deep dive into the synergy between Canva and AI, showcasing how this powerful combination can revolutionize your design process.
Dr. Kimberly N. West | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThis 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 | Duration: 75 Minutes | Price: ¤150.00 | View DetailsWe 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. 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsIn our world, regulations keep changing and we need to be able to adopt to them. It's really important for us to connect rules & regulations to roles in our organization. We are going to take a project management approach to recent rules & regulations and show how we need to act in order to effectively implement them
Justin Muscolino | Duration: 60 Minutes | Price: ¤150.00 | View DetailsUpon 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: ¤150.00 | View DetailsHuman 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsFew 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: ¤150.00 | View DetailsServices make up some 75% of the overall economic activity. But this economic reality is not visible in quality management.
Willy Vandenbrande | Duration: 75 Minutes | Price: ¤150.00 | View DetailsWe 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 | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThere 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: ¤150.00 | View DetailsWe 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 | Duration: 60 Minutes | Price: ¤150.00 | View DetailsOne 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.
John E Lincoln | Duration: 4 Hours | Price: ¤445.00 | View DetailsHuman 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsAccording to Forrester, organizations that use data to derive insights for decision-making are almost three times more likely to achieve double-digit growth.
Prashanth Southekal | Duration: 60 Minutes | Price: ¤150.00 | View DetailsDuring 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 | Duration: 60 Minutes | Price: ¤150.00 | View DetailsUnlock 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsIf 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsWe 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsIt’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 | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThere 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 | Duration: 3 Hours | Price: ¤290.00 | View DetailsTraining programs have evolved through time. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths.
Ginette Collazo | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThis 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThe 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 | Duration: 60 Minutes | Price: ¤150.00 | View DetailsIn 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsDuring 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsThis 2-Hour Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls.
David Nettleton | Duration: 2 Hours | Price: ¤190.00 | View DetailsYour 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 | Duration: 60 Minutes | Price: ¤150.00 | View DetailsThis 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsFDA’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. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.
Carolyn Troiano | Duration: 90 Minutes | Price: ¤150.00 | View DetailsIn 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 | Duration: 60 Minutes | Price: ¤150.00 | View DetailsWe 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsAre 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 | Duration: 90 Minutes | Price: ¤150.00 | View DetailsIn 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. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.
Carolyn Troiano | Duration: 90 Minutes | Price: ¤150.00 | View DetailsTopic: Not Specified
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