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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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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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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
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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
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Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.
Robert J. Russell |
Duration: 4 Hours |
Price: ¤445.00
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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
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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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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
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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
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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
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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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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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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
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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
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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
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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
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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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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
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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
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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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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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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
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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
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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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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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Pharmaceutical manufacturing sites continuously compete within the same company to maintain production volumes and avoid closures.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
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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
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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
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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
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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
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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
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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
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Still unsure? Consider this: regulators are already discussing AI's implications for financial services.
Justin Muscolino |
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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This webinar will discuss the Q-Submission program, with includes Pre-Subs, Submission Issue Requests (SIRS), Study Risk Determinations, Informational Meetings, PMA 100-Day Meetings, and other meetings and uses for Q-Sub requests.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
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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
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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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AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
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
| View Details
This training is your opportunity to eliminate that uncertainty.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
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
| View Details
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
| 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
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
| View Details
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
| 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
Assessment of the cause for a non-compliance is a structured series of branching questions.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
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
| 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
| View Details
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
| View Details
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
| 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
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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