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.

Excel - Beyond the Bar Chart - Data Visualization and Data Story Telling Techniques Overview

Revolutionize the way you communicate data with this cutting-edge training on Excel visual storytelling. Discover the power of visual data representation to transform complex numerical information into compelling, insightful visual narratives.

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.

Design Control for Medical Devices Including Verification/Validation

Verification and validation of design inputs is a critical step in the development of medical devices.

Excel ChatGPT Masterclass 3 - Work Smarter and Faster

A customised practical Excel Worksheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.

Understanding How TARIFFS Affect Global Trade Dynamics and International Business Practices

Tariffs are more than just taxes on imports-they are instruments of trade policy that influence the behavior of nations, companies, and consumers.

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.

Excel ChatGPT Masterclass 4 - Gain The Competitive Advantage

A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.

How Countries Negotiate TARIFFS, Trade Deals, And Agreements, And Their Effect on Global Markets

Trade deals and tariff negotiations are key tools governments use to influence economic outcomes, build alliances, and protect domestic industries.

Excel: Tips and Tricks and Shortcuts

Microsoft Excel has become the de facto spreadsheet application for business.

Guidance On How to Navigate Tariff Regulations, Including Legal Considerations and Compliance Procedures

This training provides detailed, practical insight into navigating tariff regulations, focusing on legal obligations and the compliance processes that international businesses must follow.

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.

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).

2-Day Virtual Seminar on Risk-based Computer System Validation: Reduce Costs and Avoid 483s

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.

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. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and fixed

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.

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.

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.

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.

Excel ChatGPT Masterclass 5 - Achieve More in Less Time

A customised practical Excel WorkSheet example is provided in sequence for each question posed to ChatGPT for demonstration and "hands-on" practice by attendees.

Practical Implementation of Quality Risk Management (QRM)

Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM, explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions.

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.

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).

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. This session will introduce you to the seamless integration of ChatGPT with Excel, showing how AI can dramatically boost your spreadsheet capabilities.

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

Fair Debt Collection Practices Act (FDCPA)

During this webinar, Justin will discuss an overview of the FDCPA, history, provisions, recent updates and how it came about.

Tariffs & Beyond: Future of Global Trade Dynamics and International Business Practices

As global trade undergoes profound changes, companies and governments must look beyond today's tariff challenges and prepare for a more complex, uncertain future.

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.

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.

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.

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).

Think Straight to Decide Right: Introduction to Critical Thinking

This session explains how to participants can improve their ability to resolve a problem or issue by breaking down its components, evaluating alternative solutions, selecting the most logical and cost-effective option and implementing it.

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.

GDPR - How to Protect Your Organization

Data protection and privacy is an important issue this day and age for the public.

Mapping and Review of Pharmaceutical Manufacturing and Packaging Workflows

Mapping and evaluating all the steps in a pharmaceutical manufacturing and packaging workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.

DeepSeek for Excel Essentials Made Easy

Mastering AI is now a fundamental and highly marketable skill set in Excel and is vital in a wide range of professions and fields including public service, banking, accounting, financial analysis, and business administration.

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.

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.

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.

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.

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.

Mastering Cross-Functional Collaboration in Research & Development

Effective collaboration between diverse corporate functions is critical for success in Research & Development (R&D).

Understanding and Implementing a Technology Transfer Process

Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.

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.

Mapping and Review of Pharmaceutical Warehousing and Distribution Workflows

Mapping and evaluating all the steps in a pharmaceutical warehousing and distribution workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.

Learn the Dos and Don'ts of Opening Business Bank Accounts

It’s about time we leverage the tools and resources to make us more effective and efficient. I’m talking about ChatGPT. As with any tools, there are pros and cons. We will discuss the background, understanding general concepts, the tools available and what the future may bring.

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.

How Better Working Capital Management Can Improve Shareholder Value

Lenders, accountants, and suppliers are in an excellent position to use their knowledge to serve as effective financial advisors to their borrowers.

Risk Management Strategies for Life Science Projects

Effective risk management is essential for ensuring the success of life science projects, where regulatory compliance, operational efficiency, and financial sustainability are critical.

Digital Assets & The Associated Compliance Risks

We must be aware of the compliance risks that are relevant with digital assets, specifically, cryptocurrencies.

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.

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.

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.

DeepSeek for Excel Intermediate Masterclass 3 - Work Smarter and Faster

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.

4-Hour Virtual Seminar on Credit Risk Management - Principles and Practices, Tools and Techniques

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.

How to Conduct a Human Factors/ Usability Validation

This webinar will explain the procedure described in ISO 62366, the FDA Guidance, and the new draft Guidance for a compliant human factors/ usability validation.

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).

4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

DeepSeek for Excel Intermediate Masterclass 4 - Gain the Competitive Advantage

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.

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

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.

Understanding and Implementing a Quality by Design Program

This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization.

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.

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.

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.

Project Scheduling Techniques for Medical Device Submissions in US and EU

Medical device submissions in the US and EU require precise project scheduling to ensure timely regulatory approvals.

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences.

6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

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.

Excel DeepSeek MasterClass 5 - Achieve More in Less Time

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.

Excel - Reporting Simplified - Learn Pivot Tables from Scratch

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.

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.

Design Control for Medical Devices: Overview and Design Inputs

In this webinar, we will examine the overall structure of design control as it relates to the development of medical devices.

Excel - 10 Key Worksheet Functions to Skyrocket Your Productivity

An often-asked question by Excel users is "Which Excel worksheet functions are truly essential?"

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.

Credit Risk Management: Principles and Practices, Tools and Techniques

The regulatory agencies and investors expect bank and other organizations extending credit to possess a strong credit culture. This session will explain what a credit culture is, how to implement it, and how to maintain a strong credit culture.

Project Scheduling Techniques for Drug Development Submissions if US and EU

Regulatory submissions for drug development require precise project scheduling to meet critical milestones and ensure timely market entry.

DeepSeek for PowerPoint Essentials Made Easy

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.

5S for Operators and Human Error Reduction

Human error is the primary cause of quality and production losses in many industries.

How to Deal with Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions.

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.

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.

GAAP-Update on New Accounting Principles and How They Impact Borrowers' Financial Statements

Several new principles warrant review to understand how they will affect both borrowers and lenders-new GAAP for revenue recognition, lease capitalization, current expected credit losses (CECL) as well as changes to not-for-profit financials.

Managing Global Teams in the Life Science Sector

Managing global teams in the life sciences sector requires a strategic approach to leadership, communication, and regulatory alignment.

6-Hour Virtual Seminar on Establish a Compliant Medical Device Post Market Surveillance and Complaint Handling System

This webinar will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices. Section 522 is implemented in 21 CFR 822.

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."

Word Professional Formatting Techniques Beyond the Basics

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.

Budgeting and Resource Allocation for Clinical Trials

Effective budgeting and resource allocation are critical to the success of clinical trials, ensuring financial sustainability while maintaining compliance and efficiency.

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.

Power BI - Getting Started Building Reports and Dashboards

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"

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.

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacture

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.

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.

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.

Overcoming Common Challengers in Life Sciences Project Management

Life sciences projects are highly complex, requiring a strategic approach to managing regulatory compliance, cross-functional teams, budgets, and timelines.

How to Use Financial Ratios in Credit Analysis

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.

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.

Design Control for Medical Devices Including Verification/Validation

Verification and validation of design inputs is a critical step in the development of medical devices.

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.

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.

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.

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.

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.

Understanding FDA's QSR Transition to ISO 13485: Implications for Medical Device Companies

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.

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.

How to Prepare for and Conduct a Regulatory Audit

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.

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.

EU MDR and IVDR: Key Updates and Compliance Strategies for 2025

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.

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.

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.

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.

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.

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).

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

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.

FDA and EMA Expectations for Good Documentation Practices (GDP) in GMP and GCP Environments

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.

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

How to Evaluate Your Borrower's Ability to Survive Inflation and Recession over the Business Cycle

What complicates survival in this current economic environment is the combination of elevated inflation and possible recession

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.

Risk-Based Approach to Supplier Qualification in GMP Manufacturing

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.

How to Deal with Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions.

MENA Regulatory Compliance for Life Science Products [Determining Strategy & Priority Markets] UAE, Israel, Saudi Arabia, Egypt, Turkey, Kuwait, Oman, Qatar, Bahrain, Jordan

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

Projecting and Financing a Borrower's Long-Term Sales Growth and Its Cash Flow Repayment Ability

Learn key assumptions in a projection and how to assess validity, the value of a downside-most likely projection to stress test the assumptions

GMP Compliance for Biopharmaceuticals and Cell & Gene Therapy Products

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.

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.

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.

Assess Impact for Supplier Change Notices

This webinar will present strategies and tools for doing a complete and comprehensive impact assessment of supplier change notices.

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Post-Market Surveillance (PMS) and Vigilance Reporting for Medical Devices and Combination Products

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.

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.

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.

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.

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.

Design Control for Medical Devices: Overview and Design Inputs

Verification and validation of design inputs is a critical step in the development of medical devices.

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.

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.

Design Control for Medical Devices Including Verification/Validation

Verification and validation of design inputs is a critical step in the development of medical devices.

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

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.

How to Prepare for and Conduct a Regulatory Audit

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.

ChatGPT & AI for Proj, Mgmt, for FDA-Regulated Cos

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.

How to Deal with Bad Results Under GLP

Assessment of the cause for a non-compliance is a structured series of branching questions.

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

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).