- 30
- October
- 30
- Tuesday
Annual Membership Offer
This 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
| View Details
- 12
- September
- 12
- Friday
ChatGPT 101 - Beginners Guide
Begin your journey into the world of AI with ChatGPT 101 - Beginner's Guide.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 12
- September
- 12
- Friday
SOX: Internal Controls for Accounts Payable
SOX compliance is more than just checking boxes-it’s about building a control environment that ensures the accuracy and integrity of financial data. One of the most critical areas to get right is Accounts Payable. With hundreds or thousands of transactions flowing through the AP process every month, any breakdown in controls can lead to serious financial misstatements.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 12
- September
- 12
- Friday
Design Control for Medical Devices Including Verification/Validation
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
- 12
- September
- 12
- Friday
Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data
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
- 12
- September
- 12
- Friday
Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Robert J. Russell |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 12
- September
- 12
- Friday
Emergency Preparedness - What To Do In Case of Fire, Flood, Tornado, Bomb Threat, Power Outage, etc
Unlock the art of emergency preparedness in this Emergency Preparedness Course. From fire safety essentials to flood preparedness, tornado survival strategies, bomb threat response, power outage readiness, and effective communication strategies - this course is your passport to effectively navigating and having confidence in dealing with these critical situations.
Joe Keenan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 12
- September
- 12
- Friday
Why EBITDA Doesn't Spell Cash Flow But What Does
Both lenders and borrowers like to to use EBITDA as proof of repayment ability, but as noted earlier, it overestimates repayment ability.
Dev Strischek |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 15
- September
- 15
- Monday
ChatGPT & Technical Writing use the Tool to Boost your Productivity and Writing Quality
This 60-minute webinar explores how ChatGPT can revolutionize technical writing by enhancing productivity, accuracy, and clarity in document creation.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 15
- September
- 15
- Monday
1099 and W-9 Update - Complying with IRS Information Reporting
Complying with IRS information reporting requirements can be a complex and frustrating process-especially when it comes to Forms 1099 and W-9.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 15
- September
- 15
- Monday
Excel - Dynamic Array Functions - A Game-changer in Formula Creation Overview
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
- 15
- September
- 15
- Monday
Enterprise Risk Management: Balancing Risk Appetite and Risk Tolerance
In today's world of evolving technologies and businesses, financial organizations are taking on increasing levels of risk.
Dev Strischek |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 16
- September
- 16
- Tuesday
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.
David Nettleton |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 16
- September
- 16
- Tuesday
Excel PowerQuery and PowerPivot
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 16
- September
- 16
- Tuesday
Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats
This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.
Michael Esposito |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 16
- September
- 16
- Tuesday
ChatGPT for CPAs and Finance Professionals
Still unsure? Consider this: regulators are already discussing AI's implications for financial services.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 17
- September
- 17
- Wednesday
Compressed Gas Storage Safety
What would your Employees do if someone gets seriously hurt in the workplace or at home?
Joe Keenan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 17
- September
- 17
- Wednesday
Clinical Trial Risk Management: ICH E6(R3) and FDA Expectations
This 60-minute webinar on Clinical Trial Risk Management will provide a comprehensive overview of the evolving regulatory landscape under ICH E6(R3) and FDA expectations for risk-based quality management (RBQM).
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 17
- September
- 17
- Wednesday
Impact Assessment and Risk Management for Change Control
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
| View Details
- 17
- September
- 17
- Wednesday
Time-Saving Chart Tricks Every Excel User Should Know
Take your Excel charts from basic to brilliant in this power-packed session! Discover how to create more impactful data visualizations by mastering advanced charting techniques that most users never explore.
Ray Evans |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 17
- September
- 17
- Wednesday
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Robert J. Russell |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 17
- September
- 17
- Wednesday
6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
John E Lincoln |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 18
- September
- 18
- Thursday
Electronic Payment Fraud Prevention Best Practices
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
- 18
- September
- 18
- Thursday
Decision Making and Human Error
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
- 18
- September
- 18
- Thursday
4-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
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
- 19
- September
- 19
- Friday
PowerBI
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
- 19
- September
- 19
- Friday
Data Integrity and Privacy: 21 CFR Part 11, Annex 11, & General Data Protection Regulation (GDPR)
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
- 19
- September
- 19
- Friday
Unlock Excel Power with Microsoft Copilot
Imagine having an expert assistant that helps you work faster and smarter in Excel. In this groundbreaking webinar, Microsoft Certified Trainer Ray will show you how Copilot transforms Excel from a simple spreadsheet tool into a powerful AI-powered productivity machine.
Ray Evans |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 19
- September
- 19
- Friday
Understanding EBITDA: A Key Financial Metric
EBITDA is a foundational metric in financial analysis but it's also one of the most misused.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 22
- September
- 22
- Monday
Medical Device Software Validation Meeting: FDA Regulations
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 22
- September
- 22
- Monday
Agile vs. Traditional Project Management in Life Sciences: Choosing the Right Approach
This 60-minute webinar explores the key differences between Agile and Traditional (Waterfall) Project Management in the life sciences industry, helping professionals determine the best approach for their specific projects
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 22
- September
- 22
- Monday
Using ChatGPT with Excel
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
- 22
- September
- 22
- Monday
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 22
- September
- 22
- Monday
Estimating Seasonal Borrowing Needs and Ability to Repay
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
| View Details
- 23
- September
- 23
- Tuesday
Financial Statement Ratio Analysis
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
- 23
- September
- 23
- Tuesday
Regulatory Requirements for Personnel Training to Assure QSR and ISO Compliance
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
| View Details
- 23
- September
- 23
- Tuesday
Function, Preparation, and Execution of Job Aids in the Pharmaceutical Industry
Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.
Michael Esposito |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 24
- September
- 24
- Wednesday
How to Prepare for and Host an FDA Inspection and Respond to 483's
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 24
- September
- 24
- Wednesday
Bloodborne Pathogens (BBP) Training
What would your Employees do if someone gets seriously hurt in the workplace or at home?
Joe Keenan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 24
- September
- 24
- Wednesday
Nonconformance/CAPA: Five (5) Improvements with Impact
This presentation will outline five targeted improvements to enhance the quality and effectiveness of Nonconformance and CAPA records. In addition to strengthening record content, it will offer practical guidance to support sound decision-making throughout the Nonconformance and CAPA process. Each improvement will be accompanied by real-world examples and actionable steps to support successful implementation.
Alicia Rice |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 24
- September
- 24
- Wednesday
Agile and Traditional Project Management Perfect together - A Hybrid Approach
This webinar explores the power of Hybrid Project Management, combining the structured, predictable approach of traditional Waterfall methodologies with the flexibility and adaptability of Agile practices.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 24
- September
- 24
- Wednesday
Validation Sampling Plans, Setting Acceptance Specifications, and Statistical Process Control
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
| View Details
- 24
- September
- 24
- Wednesday
Excel Meets AI - How Microsoft Copilot Can Save You Time
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
| View Details
- 24
- September
- 24
- Wednesday
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 24
- September
- 24
- Wednesday
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.
Robert J. Russell |
Duration: 3 Hours |
Price: ¤299.00
| View Details
- 24
- September
- 24
- Wednesday
4-Hour Virtual Seminar on How to Write Better Communications and Emails
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
- 25
- September
- 25
- Thursday
Financial Storytelling: Presenting Your Numbers with Confidence
This training helps you bridge the gap between financial analysis and impactful communication.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 25
- September
- 25
- Thursday
Best Practices in Preparation for an FDA Computer System Audit
FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 25
- September
- 25
- Thursday
How to Formally Measure Training Effectiveness
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
| View Details
- 26
- September
- 26
- Friday
Best Practices for Technical Writing in Regulatory Submissions: INDs, NDAs, and PMAs
Effective technical writing is critical for successful regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Premarket Approval (PMA) submissions.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 26
- September
- 26
- Friday
Project Management: A Primer
Project Management: A Primer is a comprehensive introductory session designed to provide participants with a solid foundation in project management principles and practices.
Joanne Gallagher |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 26
- September
- 26
- Friday
Trends in FDA Compliance and Enforcement for Regulated Systems
FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 26
- September
- 26
- Friday
Understanding EBITDA - Definition, Formula & Calculation
EBITDA is one of the most commonly used financial metrics in business but also one of the most misunderstood.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 26
- September
- 26
- Friday
Excel Meets AI - Using ChatGPT with Excel
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
| View Details
- 26
- September
- 26
- Friday
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Robert J. Russell |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 26
- September
- 26
- Friday
6-Hour Virtual Seminar on Project Management for Non-Project Managers
What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.
Charles H. Paul |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 26
- September
- 26
- Friday
How to use Financial Statement Ratios in Credit Analysis
This session will explain how to employ ratios to measure and evaluate a borrower’s performance and financial condition.
Dev Strischek |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 26
- September
- 26
- Friday
4-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
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
- 29
- September
- 29
- Monday
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 29
- September
- 29
- Monday
Excel + AI: The Smart User's Guide to Faster, Easier Work with ChatGPT
AI isn't just a buzzword - it's a game-changer for Excel users. In this hands-on session, you'll discover how to combine the power of Excel with ChatGPT to boost your productivity, simplify complex tasks, and unlock new levels of efficiency. Whether you’re stuck writing tricky formulas, wrangling messy data, or building dashboards, ChatGPT can become your on-demand assistant.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 29
- September
- 29
- Monday
CoPilot for HR Professionals
This course is designed to equip HR professionals with the tools and know-how to harness Microsoft 365 Copilot and Copilot Studio to transform HR workflows. In this course, you’ll explore hands-on use cases-from recruitment and onboarding to employee engagement and policy development-empowering HR teams to become more productive, data-driven, and employee-centric.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 30
- September
- 30
- Tuesday
How to Prepare for a Regulatory Inspection: FDA, EMA, and Notified Body Audits
This 60-minute webinar provides a comprehensive guide on how to effectively prepare for regulatory inspections conducted by the FDA, EMA, and Notified Bodies.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 30
- September
- 30
- Tuesday
How to Deal with Bad Results Under GLP
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
- 30
- September
- 30
- Tuesday
Using CoPilot with Excel
This course is designed to teach learners how to use COPILOT 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
- 30
- September
- 30
- Tuesday
Introduction to CoPilot for Business Professionals
This webinar will equip business professionals with the tools to harness Microsoft 365 Copilot for smarter, AI-powered workflows.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 30
- September
- 30
- Tuesday
Understanding Financial Statements for Non-Financial Professionals
This training is your opportunity to eliminate that uncertainty.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 30
- September
- 30
- Tuesday
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Robert J. Russell |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 30
- September
- 30
- Tuesday
4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.
John E Lincoln |
Duration: 4 Hours |
Price: ¤445.00
| View Details
- 30
- September
- 30
- Tuesday
6-Hour Virtual Seminar on Bootcamp on Excel
In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.
Tom Fragale |
Duration: 6 Hours |
Price: ¤545.00
| View Details
- 1
- October
- 01
- Wednesday
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 1
- October
- 01
- Wednesday
How to Reduce Human Error in a GMP Manufacturing/Floor
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 2
- October
- 02
- Thursday
Excel for Financial Analysis Beyond Basic Formulas
Financial professionals know that data is only as valuable as your ability to analyze it.
Ray Evans |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 2
- October
- 02
- Thursday
Building a Compliant Training Program for GMP, GCP, and Quality Systems
A compliant training program is essential for ensuring personnel in GMP, GCP, and quality system-regulated environments are knowledgeable, competent, and audit-ready.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 2
- October
- 02
- Thursday
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
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
- 2
- October
- 02
- Thursday
How to Effectively Navigate OSHA Compliance Audits
OSHA inspections can happen with little or no notice. Being unprepared can result in citations, fines, and operational disruption. This session delivers practical steps to prepare for, manage, and follow up on OSHA audits to achieve the best possible outcome.
Joe Keenan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 3
- October
- 03
- Friday
Break Free from Old Excel: How Dynamic Arrays Transform Formula Creation
If you're still building formulas the old way - one cell at a time, you're missing out on one of Excel's most powerful modern features: dynamic arrays.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 3
- October
- 03
- Friday
The Transfer of Validated Methods
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 6
- October
- 06
- Monday
Introduction to CoPilot for Business Professionals
This webinar will equip business professionals with the tools to harness Microsoft 365 Copilot for smarter, AI-powered workflows.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 6
- October
- 06
- Monday
Validating FDA-Regulated Systems Using AI, ML & LLMs, such as ChatGPT
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, ML and ChatGPT and others are becoming prevalent.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 6
- October
- 06
- Monday
The DHF, DMR, DHR, and the Technical Documentation File - The US FDA and EU MDR Requirements
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
| View Details
- 7
- October
- 07
- Tuesday
Human Error Solutions: How We Reduced 60% of Human Errors in Less Than a Year, a Case Study
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
- 7
- October
- 07
- Tuesday
Excel Data Mastery Interactive PivotTables & Dashboards for Finance Pros
Transform your financial data analysis with next-level PivotTable techniques!
Ray Evans |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 7
- October
- 07
- Tuesday
Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and The New FDA Draft Guidance
Human Factors/ Usability is the analysis of how people interact with medical devices.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 7
- October
- 07
- Tuesday
Budgeting & Forecasting Basics: Build a Rolling 12-Month Model
Budgeting and forecasting are at the heart of sound financial management. But while many organizations still rely on static annual budgets, these tools often fall short in fast-changing environments. A rolling 12-month model offers a dynamic alternative, providing continuous visibility into financial performance and keeping leadership aligned with evolving business conditions.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 7
- October
- 07
- Tuesday
Heat Stress Avoidance Training
Exposure to high temperatures-indoors or outdoors-can lead to serious heat-related illnesses, reduced productivity, and even fatalities. This training provides proven strategies to recognize, prevent, and respond to heat stress hazards in compliance with OSHA recommendations.
Joe Keenan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 8
- October
- 08
- Wednesday
Excel: Stop Cleaning Data Manually Let Power Query Do It
If your spreadsheets are full of inconsistent data, awkward formatting, or endless copy-paste routines, you need Power Query!
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 8
- October
- 08
- Wednesday
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 8
- October
- 08
- Wednesday
Finance Dashboard Lab in Excel: From Trial Balance to Exec KPIs
Creating a financial dashboard in Excel from a trial balance involves several key steps, from data preparation to calculating and visualizing executive-level key performance indicators (KPIs). A well-structured dashboard allows leaders to quickly assess financial health, track performance, and make informed decisions without wading through detailed reports.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 9
- October
- 09
- Thursday
Power BI for Beginners - Turn Data into Decisions
Are you ready to embark on a journey that will revolutionize the way you work with data? Welcome to "Power BI for Beginners - Turn Data into Decisions"
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 9
- October
- 09
- Thursday
Excel Pivot Tables
We will start with the basics and built up to more complex pivot tables.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 9
- October
- 09
- Thursday
Excel's AI Revolution: Master ChatGPT's Advanced Functions
Join us for an exciting and interactive webinar where we dive into the world of AI-powered Excel with the ChatGPT Add-In.
Ray Evans |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 9
- October
- 09
- Thursday
Effective SOP Writing and Management for Regulatory Compliance
Effective Standard Operating Procedure (SOP) writing and management are critical for ensuring regulatory compliance and operational consistency.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 10
- October
- 10
- Friday
Validating FDA-Regulated Systems Supporting Medical Devices & SaMD Products Using AI, ML & LLMs, such as ChatGPT
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, ML and ChatGPT and others are becoming prevalent.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 10
- October
- 10
- Friday
Analytical Method Validation Under Good Laboratory Practices - GLPs
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 10
- October
- 10
- Friday
Eye and Face Protection (PPE) - Beyond Basics
Workplace eye and face injuries are preventable when the correct protective equipment is properly selected and used. This session dives deeper than PPE basics to address hazard-specific protection, compliance requirements, and effective program management.
Joe Keenan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 13
- October
- 13
- Monday
The DHF, DMR, DHR, and the Technical Documentation File - The US FDA and EU MDR Requirements
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
| View Details
- 13
- October
- 13
- Monday
Medical Device Change(s) and the 510(k)
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
- 14
- October
- 14
- Tuesday
Excel PowerQuery and PowerPivot
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 14
- October
- 14
- Tuesday
PowerPoint Advanced Techniques - Build A Video Presentation
Mastering advanced PowerPoint techniques is a powerful asset across diverse industries including marketing, social media, public service, banking, accounting, financial analysis, and business administration.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 14
- October
- 14
- Tuesday
Capital Budgeting Made Simple: NPV, IRR, Payback for Managers
Capital budgeting is the process of evaluating investment opportunities to determine which projects will generate the most value for an organization. Key financial metrics such as Net Present Value (NPV), Internal Rate of Return (IRR), and payback period are central to this evaluation, but they are often perceived as complicated or intimidating. This session breaks these concepts down in simple, practical terms.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 15
- October
- 15
- Wednesday
Medical Device Software Validation Meeting: FDA Regulations
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 15
- October
- 15
- Wednesday
How to Implement an Effective Human Error Investigation Program
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
- 15
- October
- 15
- Wednesday
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
Verification and validation requirements have always been part of the US FDA's GMPs. Yet companies still struggle with the performance of and documentation of Equipmnet, Process, Software, and quality management system validations.
John E Lincoln |
Duration: 3 Hours |
Price: ¤299.00
| View Details
- 15
- October
- 15
- Wednesday
OSHA Requirements for Temporary Workers
Temporary and contract workers face unique safety challenges. OSHA’s joint employer doctrine makes both the staffing agency and host employer responsible for safety. This webinar explains how to protect temporary workers and ensure compliance.
Joe Keenan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 15
- October
- 15
- Wednesday
Forecasting in Excel: Scenario Planning with What If and Solver
Forecasting in Excel uses What-If Analysis and Solver to analyze different scenarios and find optimal outcomes.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 16
- October
- 16
- Thursday
Agile Principles and Practices: A Primer
Our Agile primer is a comprehensive introductory session designed to unlock the transformative power of agile methodologies for professionals across all industries. This course takes participants on a journey through the fundamental principles that have revolutionized how teams approach problem-solving, decision-making, and value delivery in fast-changing environments.
Joanne Gallagher |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 16
- October
- 16
- Thursday
Data Dominance Create, Filter, Sort, and Customize Like a Power User
Ready to transform chaotic data into organized insights?
Ray Evans |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 16
- October
- 16
- Thursday
Pivot Tables - The Secret to Fast, Flexible Excel Reporting
Pivot Tables are one of Excel’s most powerful and misunderstood tools but once you know how to use them, they can transform how you analyse and report on data. In just a few clicks, you can summarise thousands of rows into meaningful, dynamic reports - no formulas required.
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 17
- October
- 17
- Friday
Cash Flow 101: From Profits to Liquidity You Can Spend
Cash flow is the lifeblood of every business. While profitability shows how well a business performs on paper, cash flow reveals whether the business can sustain itself in reality. Understanding this difference is essential for anyone responsible for managing or analyzing financial performance.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 17
- October
- 17
- Friday
Root Cause Analysis and CAPA Implementation for GMP Compliance
This webinar will provide a practical framework for identifying, analyzing, and addressing deviations in pharmaceutical and biopharmaceutical manufacturing.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 20
- October
- 20
- Monday
PowerBI
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
- 20
- October
- 20
- Monday
The Q-Submission Program Guidance for Medical Device Submissions to FDA
Providing safe and effective medical devices is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. You will learn about the Q-Submission program providing industry with pathways for engaging FDA early for feedback to aid in product development.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 20
- October
- 20
- Monday
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
John C. Fetzer |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 20
- October
- 20
- Monday
Mastering PivotTables- Excels Ultimate Tool for Smarter Data Management
Discover how to turn complex data into clear, actionable insights-fast! PivotTables are one of Excel’s most powerful tools, allowing you to instantly summarize, filter, group, and analyze large data sets with just a few clicks.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 21
- October
- 21
- Tuesday
Finance for Sales Managers: Pricing Discipline and Discount Guardrails
Pricing and discounting decisions are critical levers for driving revenue while maintaining profitability. Sales managers need to understand the financial impact of these decisions to balance short-term sales goals with long-term business sustainability.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 21
- October
- 21
- Tuesday
The Human Error Toolbox: A Practical Approach to Human Error
Human error is known to be the primary cause of quality and production losses in many industries. Although 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
- 22
- October
- 22
- Wednesday
How to use ChatGPT & AI for Project Management to Improve FDA Compliance for Computer Systems & Data
The guidance on validation has been modified with the FDA's proposed draft guidance for Computer Software Assurance (CSA) in September 2022.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 22
- October
- 22
- Wednesday
How to Prepare for and Host an FDA Inspection and Respond to 483's
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 22
- October
- 22
- Wednesday
Modern Excel: The New Functions That'll Change How You Work
Excel has changed. Have you? Over the past few years, Microsoft has added a wave of powerful new functions that simplify tasks, streamline formulas, and make your spreadsheets more dynamic than ever. If you're still relying solely on old favourites like VLOOKUP, IF, and COUNTIF, you're missing out on what's now possible.
Mike Thomas |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 22
- October
- 22
- Wednesday
Excel Data Mastery Smart Calculations, Automation & Reporting for Finance Professionals
Turn Financial Data into Actionable Insights - Faster Than Ever
Ray Evans |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 22
- October
- 22
- Wednesday
OSHA's Global Harmonized Standard (GHS) / HazCom
OSHA’s Hazard Communication Standard is undergoing major changes in 2025. This training reviews the updated labeling, SDS requirements, and chemical classification standards - and how to implement them efficiently.
Joe Keenan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 23
- October
- 23
- Thursday
Project Management: A Primer
Project Management: A Primer is a comprehensive introductory session designed to provide participants with a solid foundation in project management principles and practices.
Joanne Gallagher |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 23
- October
- 23
- Thursday
ChatGPT for Excel
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
- 23
- October
- 23
- Thursday
5S for Operators and Human Error Reduction
Human error is the primary cause of quality and production losses in many industries.
Ginette Collazo |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 23
- October
- 23
- Thursday
Unlock Excel Power with Microsoft Copilot
Imagine having an expert assistant that helps you work faster and smarter in Excel. In this groundbreaking webinar, Microsoft Certified Trainer Ray will show you how Copilot transforms Excel from a simple spreadsheet tool into a powerful AI-powered productivity machine.
Ray Evans |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 24
- October
- 24
- Friday
Financial Storytelling: Presenting Results to Executives in 10 Slides
Financial storytelling combines data analysis, communication skills, and strategic insight to deliver impactful presentations to executives.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 24
- October
- 24
- Friday
Risk Management for AI in Medical Devices: Insights from FDA's Lifecycle Management Draft Guidance
The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called "locked" algorithms that don't continually adapt or learn every time the algorithm is used.
John E Lincoln |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 24
- October
- 24
- Friday
Organizational Change Management for Transformation: A Primer
A Primer is a comprehensive introductory session designed to provide participants with essential knowledge and practical tools for navigating organizational change successfully.
Joanne Gallagher |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 24
- October
- 24
- Friday
Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements
This webinar, Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements, provides a comprehensive overview of data integrity principles, regulatory expectations, and compliance strategies in pharmaceutical and clinical environments.
Charles H. Paul |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 28
- October
- 28
- Tuesday
Forecasting in Excel: Scenario Planning with What-If and Solver
Forecasting allows organizations to anticipate outcomes, plan resources, and make informed decisions.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 28
- October
- 28
- Tuesday
QMS 101: Quality Management System Guide
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
- 28
- October
- 28
- Tuesday
Excel - A Beginner's Guide to Formulas
Excel is an essential tool for anyone who works with data, from entry-level employees to professionals. Knowing how to use Excel formulas can help you streamline your work, increase accuracy, and save time.
Mike Thomas |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 28
- October
- 28
- Tuesday
ChatGPT 101 - Beginners Guide
Begin your journey into the world of AI with ChatGPT?101 - Beginner's Guide.
Tom Fragale |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 28
- October
- 28
- Tuesday
Decision Making and Human Error
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
- 28
- October
- 28
- Tuesday
Excel Essentials for Finance Pros SUM, SORT & Speed Up Your Workflow
Unlock the Power of Excel for Finance & Accounting!
Ray Evans |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 29
- October
- 29
- Wednesday
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 29
- October
- 29
- Wednesday
How to Deal with Bad Results Under GLP
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
- 29
- October
- 29
- Wednesday
Regulatory Requirements for Personnel Training to Assure QSR and ISO Compliance
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
| View Details
- 29
- October
- 29
- Wednesday
Word PowerUser Techniques in Document Formatting MasterClass
Mastering power-user techniques in Microsoft Word is a game-changing skill across many professional fields-including public service, banking, accounting, financial analysis, and business administration.
Ray Evans |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 30
- October
- 30
- Thursday
Internal Controls for AP/AR: 12 Practical Checks to Reduce Errors and Fraud
Internal controls are essential for safeguarding an organization's financial resources, and AP/AR processes are particularly vulnerable to errors and fraud.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 30
- October
- 30
- Thursday
ChatGPT for PowerPoint Essentials Made Easy
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
- 30
- October
- 30
- Thursday
How to Prepare and Survive an OSHA Audit
Regulatory Compliance Audits can be taxing and worrisome for anyone. Having an OSHA Audit an open an organization up to receiving regulatory citations, monetary fines, negative company press, etc.
Joe Keenan |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 31
- October
- 31
- Friday
Storytelling in Project Management for Validating FDA-Regulated Computer Systems: How to Captivate & Inspire the Team
By applying storytelling to FDA-regulated system validation, attendees will:
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 31
- October
- 31
- Friday
ChatGPT / AI for Project Management for FDA-Regulated Companies
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
- 3
- November
- 03
- Monday
Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA's Recent Draft Guidance for Electronic Records/Signatures used in Clinical Trials
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 3
- November
- 03
- Monday
AI in Drug Development
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
- 4
- November
- 04
- Tuesday
KPI Design That Non-Finance Teams Will Actually Use
KPIs are only valuable if they are understood and acted upon.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 7
- November
- 07
- Friday
Device Changes, FDA Changes, and the 510(K)
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
- 7
- November
- 07
- Friday
Variance Analysis for Busy Managers: Budget vs Actuals Made Simple
Variance analysis is at the core of effective financial management and performance review. By comparing budgeted expectations to actual results, managers can understand not only whether targets were met but also why outcomes differed. This knowledge is essential for adjusting strategies, managing resources, and improving future forecasts.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 11
- November
- 11
- Tuesday
Trends in FDA Compliance and Enforcement for Regulated Systems
FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 11
- November
- 11
- Tuesday
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification
This Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure.
David Nettleton |
Duration: 2 Hours |
Price: ¤199.00
| View Details
- 11
- November
- 11
- Tuesday
Working Capital Essentials: Receivables, Payables, and Inventory Levers
Working capital management is one of the most important, yet often underappreciated, aspects of financial management. It determines a company’s ability to meet short-term obligations, fund operations, and seize new opportunities. By focusing on the three main levers-receivables, payables, and inventory-businesses can strengthen liquidity and improve efficiency.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 14
- November
- 14
- Friday
FDA Guidance for use of Social Media by Regulated Industries (Updated to include Recent Guidance from FDA)
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, tobacco and tobacco-related (e-liquid, cigars).
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 14
- November
- 14
- Friday
Month-End Close Playbook: Close Faster with Fewer Surprises
Month-end close is essential for accurate financial reporting and timely management insights, but it often presents challenges that delay reporting and create errors.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 14
- November
- 14
- Friday
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Tech. Doc, n Files - The US FDA and EU MDR Rqmts
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
| View Details
- 17
- November
- 17
- Monday
Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning Agile to the GAMP®5 "V" Model & System Development Life Cycle (SDLC)
The FDA has been moving in the direction of newer technology in an effort to no longer be a bottleneck to industry innovation.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 19
- November
- 19
- Wednesday
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
Verification and validation requirements have always been part of the US FDA's GMPs.
John E Lincoln |
Duration: 3 Hours |
Price: ¤299.00
| View Details
- 20
- November
- 20
- Thursday
GAMP®5, 2nd Edition and Alignment with FDA's Draft Guidance for Computer Software Assurance (CSA)
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
| View Details
- 21
- November
- 21
- Friday
Payment Fraud Red Flags: Protect Your Payables Today
Payment fraud is a significant risk for organizations, particularly within accounts payable.
Justin Muscolino |
Duration: 60 Minutes |
Price: ¤149.00
| View Details
- 25
- November
- 25
- Tuesday
Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data, & FDA Compliance
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
- 1
- December
- 01
- Monday
Data Integrity and Governance for Computer Systems Regulated by FDA
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 3
- December
- 03
- Wednesday
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.
David Nettleton |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 4
- December
- 04
- Thursday
Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability & Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)
Similarly, HIPAA and GDPRs extend protections to consumers residing in the US and the EU.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 9
- December
- 09
- Tuesday
Best Practices in Preparation for an FDA Computer System Audit
In particular, industry citations have increased as they relate to areas of Part 11 and data integrity.
Carolyn Troiano |
Duration: 90 Minutes |
Price: ¤149.00
| View Details
- 12
- December
- 12
- Friday
Using IT Audit Trails to Support FDA 21 CFR Part 11 and Data Integrity Compliance
FDA's recent focus on 21 CFR Part 11 and 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
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