Pack of Five Webinars

Excel Formulas and Functions

Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

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.

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.

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Unmanageable Inbox? Imagine a Clean Inbox and Take Control Today!

Do you remember when hand-written letters or typed letters was the main means of communication? If so, you may also remember how glorious it was to send information and have immediately received via the fax machine.

4-Hour Virtual Seminar on Lessons Learned from the History of Pandemics Impacting the Food Industry, Implementing a Risk-Based Plan with Next Steps for Industry After COVID-19

There is a broad need to understand the impact of global outbreaks on the food industry. Understanding the potential for pandemics will be detailed, along with historical dive into past episodes in the food industry. Drilling more deeply into nuances of the COVID-19 will also be explored for the application of best practices and early frustrations of the impact of pushing organizations beyond their comfort zones.

Human Factors/ Usability Studies following ISO62366 and the new FDA 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. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.

Excel PowerPivot and Power Query

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.

4-Hour Virtual Seminar on GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems

GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices, and cosmetics. GMP regulations describe required quality management system for production and testing of products in these regulated industries.

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 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.

Good Manufacturing Practices (GMP) - An Introduction

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries.

Food Supplier Auditing Plan, Post-COVID

You deal with hundreds of suppliers. And you need to make sure each and every one of them meets regulations and quality standards. How can you keep your eye on that many suppliers?

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.

2-Hour Virtual Seminar on The 6 Most Common Problems in FDA Software Validation and Verification

This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

4-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.

How to Conduct a Human Factors/ Usability Validation

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Developing a Food Safety Culture For FSMA

Instilling a passion with team members to create a Right Time Culture for Quality and Food Safety ensures wholesome products everyone can enjoy. This process begins with a plan aligned with FSMA, a Food Safety Roadmap, that starts at the design stage, through production, monitoring, and finally when the customer or consumer indulges in the vast array of today’s convenient food products available globally.

Excel - 10 Must-Know Functions to Boost Your Productivity

Microsoft Excel contains almost 500 built-in worksheet functions. Strip away the ones nobody uses. Discount the ones that have a specialized use-case and you're left with a small set of functions that all Excel users should know, regardless of their job function, industry, or business sector. This webinar covers ten of Excel’s most popular productivity-boosting functions.

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

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.

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

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

FDA's New Import Program for 2020 and Impact of the COVID-19

In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).

Excel: Tips and Tricks and Shortcuts

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

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.

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

Risk based Computer System Validation

FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Validation is much more than testing. It is testing plus design control and configuration management.

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.

4-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Root Cause Analysis - Starting at the Beginning

CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.

Project Management for Non-Project Managers - Determining the Work that needs to be done

This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.

6-Hour Virtual Seminar on Biostatistics for the Non-Statistician

The use of statistics in clinical trials insures a valid and robust study which minimizes bias in assessing the efficacy of new drug treatment or medical devices.

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.

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.

Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project review Meetings

This webinar is about effective communication inside and outside of the project team.

4-Hour Virtual Seminar on Mastering Excel Pivot Tables

Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.

Medical Device Cybersecurity following latest FDA Guidance

The company must establish a program where they identify, analyze and control cybersecurity risks for both pre-market and post-market. The cybersecurity program must be carefully planned. A formal special hazard analysis must be conducted for each risk. Communication of risks must be sent to devise users. A complex set of reporting requirements has been established. This webinar will describe a program that will be compliant with the FDA requirements.

4-Hour Virtual Seminar on How to Evaluate Borrower Operating Performance and Financial Condition

This program is designed to show bankers, lenders, and credit professionals how to evaluate a borrower's operating performance and financial condition. Good operating performance and a sound financial condition are critical to a borrower being able to generate sufficient cash flow from operations to repay its debt.

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.

4-Hour Virtual Seminar on Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

The objective of this seminar is to compare and contrast between Good Laboratory Practices and Good Manufacturing Practices.

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.

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. This course provides guidance on how to implement and maintain the desired level of credit risk management with practical tools and techniques.

Excel Pivot Tables , Pivot Charts, Slicers, and Timelines

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

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.

6-Hour Virtual Seminar on Statistics for Process Control

This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

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.

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

4-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.

4-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

The Most Common Problems in FDA Software Validation & Verification

This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.

C for Yourself: The 5 C's of Credit

The first four C's-capacity, conditions, collateral, and character- evaluate a borrower's ability to repay, but character forces the lender to examine closely the borrower's willingness to repay.

4-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.

Key Elements in Managing and Maintaining Your Credit Administration and Credit Policy

This session by Dev Strischek is intended to provide guidance on how to develop and maintain a Credit Administration (CA) function that will provide guidance to anyone involved in the credit function of the bank. The session also highlights the safeguards to manage the bank’s loan portfolio in a safe and sound manner.

How to write SOP's for Human Error Reduction

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

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos.

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.

The Credit Manager's Tool Box - Tools And Techniques For Making Sound Credit Decision

This webinar will provide guidance on how to gather information, evaluate it, and make sound credit decisions on prospective clients and existing borrowers You will also learn the differences between unaudited and audited financials and how to use and interpret financial ratios in your analysis. You will also learn how to write a simple but thorough credit proposal.

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.

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

Use Microsoft Outlook to Its Fullest Extent: Tips, Techniques and Best Practices. It’s Money in Your Pocket!

Microsoft Outlook is a powerful productivity tool and if you are using it only for email and for keeping track of meetings and appointments, about 80-85% of the power of Outlook is unused. You paid a great deal for the privilege of using Microsoft Outlook - why not wring every dollar you can out of it?

Cash Flow Analysis Of Borrower’s Repayment Ability

There is an old saying in credit analysis, "Borrowers pay back loans from cash flow, not profits." But it is not just cash flow; it is cash flow from operations that is the most desirable source of repayment because it is generated by a borrower managing its working capital assets and earning a sustainable profit.

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.

Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications.

Supervising a Human Error Free Environment: You can do a Lot More than you Think

Human error is known to be the major cause of quality and production losses in many industries.

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.

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

3-Hour Virtual Seminar: 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.

2-Hour Virtual Seminar on The 6 Most Common Problems in FDA Software Validation and Verification

This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications.

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.