Get 50% off with the coupon code COUPON50 Get 50% off with the coupon code COUPON50This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.
Steven Walfish |
Duration: 60 Minutes |
Price: ¤0.00
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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
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Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.
Roger Cowan |
Duration: 60 Minutes |
Price: ¤149.00
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"Some of these new mobile apps / software functions are specifically targeted to assisting individuals in their own health and wellness management. Others are targeted to health care providers as tools to improve and facilitate the delivery of patient care.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
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Ensuring that personnel are properly trained is critical for maintaining compliance with Quality System Regulations (QSR) and ISO standards in regulated industries such as medical devices and pharmaceuticals.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
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Advancements in technology have forced organizations to rethink business models.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
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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
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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
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In today's world, there are tons 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 webinar will show you how to take large amounts of data from many sources and processes into great reports.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
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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.
David Nettleton |
Duration: 90 Minutes |
Price: ¤149.00
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In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.
Alan M Golden |
Duration: 60 Minutes |
Price: ¤149.00
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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
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This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
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Unlock the power of Excel's data analysis and Business Intelligence (BI) toolkit with Pivot Tables.
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
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This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
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Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
Roger Cowan |
Duration: 75 Minutes |
Price: ¤149.00
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Advancements in technology have forced organizations to rethink business models.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
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Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.
Michael Esposito |
Duration: 60 Minutes |
Price: ¤149.00
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Life sciences projects are highly complex, requiring a strategic approach to managing regulatory compliance, cross-functional teams, budgets, and timelines.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
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The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continue to evolve, posing ongoing challenges for medical device and diagnostic manufacturers. With 2025 bringing critical deadlines, regulatory updates, and new compliance expectations, companies must stay ahead to ensure smooth market access and adherence to stringent requirements.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
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This webinar will examine the CAPA regulations, 21 CFR 211.198 (Pharma), 21 CFR 820.100 (Devices), Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and 21 CFR 822.
John E Lincoln |
Duration: 6 Hours |
Price: ¤545.00
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We'll cover in detail the differences between GAMP®5, 2nd Edition, issued in July 2022 and the original version of GAMP®5.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
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This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
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Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.
Alan M Golden |
Duration: 60 Minutes |
Price: ¤149.00
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Training 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: ¤149.00
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Going "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: ¤149.00
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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
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This webinar will walk the participant through the entire process of decomposing a project's tasks into workable schedulable elements called work packages.
Charles H. Paul |
Duration: 90 Minutes |
Price: ¤149.00
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Microsoft Excel has become the de facto spreadsheet application for business.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
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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
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A customized practical PowerPoint example is provided with slides in sequence for each question posed to DeepSeek for demonstration and “hands-on” practice by attendees.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
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An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
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The FDA’s transition from the Quality System Regulation (QSR) to ISO 13485 marks a significant shift in medical device regulatory compliance, aligning U.S. quality management requirements with global standards.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
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One of the most basic analytical and underwriting tools a banker must have is the ability to determine whether a borrower can repay its short-term borrowings based on the financial information available
Dev Strischek |
Duration: 60 Minutes |
Price: ¤149.00
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This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences.
Charles H. Paul |
Duration: 6 Hours |
Price: ¤545.00
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Tariffs are more than just taxes on imports-they are instruments of trade policy that influence the behavior of nations, companies, and consumers.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
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This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
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Mastering Power-User techniques in Microsoft Word is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
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Are you ready to embark on a journey that will revolutionize the way you work with data?
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
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Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
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Good Documentation Practices (GDP) are a critical requirement in both Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) environments, ensuring the accuracy, integrity, and reliability of records that support regulatory compliance.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
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Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
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A customized practical PowerPoint example is provided with slides in sequence for each question posed to ChatGPT for demonstration and “hands-on” practice by attendees
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
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In today's fast-paced and data-driven world, efficiency, accuracy, and innovation are more critical than ever.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
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What complicates survival in this current economic environment is the combination of elevated inflation and possible recession
Dev Strischek |
Duration: 60 Minutes |
Price: ¤149.00
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Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives.
Dev Strischek |
Duration: 4 Hours |
Price: ¤445.00
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In this webinar we will examine the process of evaluating and completing an impact assessment when applied to change control.
Alan M Golden |
Duration: 60 Minutes |
Price: ¤149.00
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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.
Robert J. Russell |
Duration: 3 Hours |
Price: ¤299.00
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This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.
Charles H. Paul |
Duration: 90 Minutes |
Price: ¤149.00
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A risk-based approach to supplier qualification in GMP manufacturing ensures that suppliers are evaluated, selected, and monitored based on their potential impact on product quality and patient safety.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
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
This training provides detailed, practical insight into navigating tariff regulations, focusing on legal obligations and the compliance processes that international businesses must follow.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
So what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far?
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
Assessment of the cause for a non-compliance is a structured series of branching questions.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
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Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
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Join this webinar to learn how to set up data in correct format and to use key features to best manage and present your data.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
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This 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
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NOTE: This course is not appropriate for Mac or Excel for Web users as the functionality does not exist on those platforms.
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
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The MENA region suffers from a Drug & Device Lag, meaning innovative products typically do not reach the market for 10+ years, after they are approved and launched in the U.S. or EU. Because of this, there exists significant opportunity for U.S. and EU developed products, if the regulatory hurdles can be navigated
Robert J. Russell |
Duration: 90 Minutes |
Price: ¤149.00
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Learn key assumptions in a projection and how to assess validity, the value of a downside-most likely projection to stress test the assumptions
Dev Strischek |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.
Roger Cowan |
Duration: 60 Minutes |
Price: ¤149.00
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In today's busy world, we are sometimes overwhelmed with huge amounts of data, sometimes that data can come from more than one table, or even more than 1 data source. Trying to make sense of this data can be an overwhelming task.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
Trade deals and tariff negotiations are key tools governments use to influence economic outcomes, build alliances, and protect domestic industries.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
Revolutionize the way you communicate data with this cutting-edge training on Excel visual storytelling.
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
Substandard product can exist even if the product itself is manufactured according to quality standards. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
Going “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: ¤149.00
| View Details
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Tom Fragale |
Duration: 6 Hours |
Price: ¤545.00
| View Details
This 60-minute webinar on GMP Compliance for Biopharmaceuticals and Cell & Gene Therapy Products provides a comprehensive overview of regulatory expectations, quality management principles, and industry best practices for ensuring compliance in these highly specialized fields.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
Object Linking and Embedding (OLE) makes content that is created in one location or program available in another program.
Ray Evans |
Duration: 75 Minutes |
Price: ¤149.00
| View Details
It is important that the sterile filtration process is fully understood and properly validated for your particular application.
Roger Cowan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points.
Charles H. Paul |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizen's personal data when they reside in the European Union (EU).
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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
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 Equipmnet, Process, Software, and quality management system validations.
John E Lincoln |
Duration: 3 Hours |
Price: ¤299.00
| View Details
This webinar will present strategies and tools for doing a complete and comprehensive impact assessment of supplier change notices.
Alan M Golden |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
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
Ratio analysis helps lenders and analysts to determine a borrower's operating performance (profitability and productivity) and financial condition (liquidity, leverage, solvency) by rendering the financial statements into ratios.
Dev Strischek |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
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
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Michael Esposito |
Duration: 4 Hours |
Price: ¤445.00
| View Details
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
Post-Market Surveillance (PMS) and Vigilance Reporting for Medical Devices and Combination Products are critical components of regulatory compliance, ensuring ongoing patient safety and product effectiveness after market approval.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
As global trade undergoes profound changes, companies and governments must look beyond today's tariff challenges and prepare for a more complex, uncertain future.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention."
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
A customized practical Excel example is provided with slides in sequence for each question posed to DeepSeek for demonstration and “hands-on” practice by attendees
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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.
Charles H. Paul |
Duration: 6 Hours |
Price: ¤545.00
| View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel, like basic navigation and data import/export.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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
Good leaders walk the talk, but they also write right. They know how to say in a few words what needs to be said in crisp, clear language.
Dev Strischek |
Duration: 4 Hours |
Price: ¤445.00
| View Details
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.
John E Lincoln |
Duration: 4 Hours |
Price: ¤445.00
| View Details
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
Robert J. Russell |
Duration: 4 Hours |
Price: ¤445.00
| View Details
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
Going "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: ¤149.00
| View Details
In today's fast-paced and highly analytical project environments, leaders often rely heavily on metrics, deadlines, and documentation to steer their teams.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
The US FDA has announced steps toward a new regulatory policy and framework specifically tailored to promote the development of safe and effective drugs using advanced artificial intelligence / machine learning algorithms by the regulated industry.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
This interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s.
David Nettleton |
Duration: 75 Minutes |
Price: ¤149.00
| View Details
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
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Roger Cowan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
In today's fast-paced and data-driven world, efficiency, accuracy, and innovation are more critical than ever. This session will introduce you to the seamless integration of ChatGPT with Excel, showing how AI can dramatically boost your spreadsheet capabilities.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
In the highly regulated world of pharmaceuticals, biotechnology, and medical devices, project managers face constant pressure to deliver results on time while ensuring strict adherence to FDA compliance requirements.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.
Roger Cowan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
A customised practical Excel Worksheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
Finance & Accounting 101 Simplified strips away the jargon and explains key financial and accounting concepts in everyday terms.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
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
Pharmaceutical manufacturing sites continuously compete within the same company to maintain production volumes and avoid closures.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
Fear of accounting often stems from not understanding the basics. Without knowing the difference between a debit and a credit-or how they flow into the income statement and balance sheet-you might miss opportunities to ask smart questions, flag errors, or explain financial issues to stakeholders. Worse, you might make decisions that unintentionally hurt your budget or your department's performance.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
Verification and validation of design inputs is a critical step in the development of medical devices.
Alan M Golden |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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
Microsoft Excel has become the de facto spreadsheet application for business.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
Elevate 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, Excel 2021 and Excel 2024 users.
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
This session is designed to eliminate that uncertainty. You'll learn how to read income statements, balance sheets, and cash flow statements with confidence. More importantly, you'll gain the skills to analyze what the numbers actually mean: profitability trends, liquidity issues, debt levels, and more. By the end of this training, you'll be able to speak the language of finance-and use it to your advantage.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
In today's world, there are tons of data to manage. Data is coming from many different sources.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
Still unsure? Consider this: regulators are already discussing AI's implications for financial services.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
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
Verification and validation of design inputs is a critical step in the development of medical devices.
Alan M Golden |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
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Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.
Roger Cowan |
Duration: 75 Minutes |
Price: ¤149.00
| View Details
FDA's recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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
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AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
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This training is designed to revolutionize the way you work with Excel. Copilot is an AI-powered tool that enhances your Excel experience by automating complex tasks, providing intelligent suggestions, and improving overall efficiency. Whether you're dealing with large datasets, creating intricate formulas, or simply trying to streamline your daily workflow, Copilot is here to help.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
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We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities by applying a sound, project management approach. Each validation effort includes a vast set of activities and tasks required to get the job done. These can be managed more effectively by better understanding how to apply a project management approach to them all, regardless of size.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
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ISO 9001 is an internatioinal standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
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This training is your opportunity to eliminate that uncertainty.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
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In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct the audit.
Alan M Golden |
Duration: 60 Minutes |
Price: ¤149.00
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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.
Robert J. Russell |
Duration: 3 Hours |
Price: ¤299.00
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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.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
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This session will equip you with the knowledge and tools needed to identify risks, strengthen internal processes, and implement practical safeguards.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
Unlock the power of Excel's data analysis and Business Intelligence (BI) toolkit with Pivot Tables. Whether you're aiming to construct dynamic dashboards, conduct in-depth data analysis, or simply streamline data summaries for personal or business purposes, Pivot Tables are your key to success.
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
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This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
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Assessment of the cause for a non-compliance is a structured series of branching questions.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
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The fear is real-many professionals nod in meetings where financials are discussed, but don't fully understand what the ratios mean or how they relate to strategic decisions.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
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A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.
Roger Cowan |
Duration: 60 Minutes |
Price: ¤149.00
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In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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
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
An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
If you work in the GMP-regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must do it because the regulation requires it.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
This training helps you bridge the gap between financial analysis and impactful communication.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
This session is designed to help you recognize these risks and take action.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
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In today's busy world, we are sometimes overwhelmed with huge amounts of data, sometimes that data can come from more than one table, or even more than 1 data source. Trying to make sense of this data can be an overwhelming task.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
Advancements in technology have forced organizations to rethink business models.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI Getting Started Building Reports and Dashboards"
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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
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Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention."
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
It is important that the sterile filtration process is fully understood and properly validated for your particular application.
Roger Cowan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
Human error is the primary cause of quality and production losses in many industries.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.
Roger Cowan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
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.
David Nettleton |
Duration: 2 Hours |
Price: ¤199.00
| View Details
Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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.
David Nettleton |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
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