Roger Cowan

Sterile Filtration of Pharmaceutical Products -What you need to know to meet Validation and Regulatory Requirements

It is important that the sterile filtration process is fully understood and properly validated for your particular application.

Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

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.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

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.

Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Roger Cowan

HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed.

Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
Roger Cowan

Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.

Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John Ryan

Responsibilities of the Carrier Under the Final FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

This is part 1 of a three part required training resulting from the finalization of new US FDA food transportation laws.

Speaker: John Ryan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John Ryan

NEW FDA Proposed FSMA Rule on Food Traceability

This 60-minute webinar will cover the proposed FDA traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls.

Speaker: John Ryan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Robert J. Russell

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.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Robert J. Russell

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.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details

Using Statistics to Determine Sample Size

We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.

View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Robert J. Russell

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.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Robert J. Russell

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.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Martin K. Behr, III

INCOTERMS 2020 Made Easy - Decoding your Shipment

The term, Incoterms®, is an abbreviation for International Commercial Terms

Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Martin K. Behr, III

Importing and Exporting Covid-19 Products

The outbreak of coronavirus disease (COVID-19), first in the People's Republic of China (PRC or China), and now globally, including in the United States, is drawing attention to the ways in which the United States and other economies depend on critical manufacturing and global value chains that rely on production based in in the PRC and other countries.

Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Martin K. Behr, III

Say Goodbye to NAFTA: The USMCA is Now Here

The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes. The United States-Mexico-Canada Agreement (USMCA), commonly referred to as the "New NAFTA," is essentially “NAFTA 2.0".

Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Miles Hutchinson

1099 and W-9 Update - Complying with IRS Information Reporting

For years the IRS has struggled with the independent contractor and tax collection.

Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Miles Hutchinson

2-Hour Virtual Seminar on Nonresident Alien W-8 & 1042-S Compliance Update

Do you have a plan to deal with IRS demands for backup withholding if you failed to deduct from payments to Nonresident Aliens' (NRAs)? The IRS is working hard to reduce the delinquent tax burden.

Speaker: Miles Hutchinson | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
John E Lincoln

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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Steven Wachs

Modeling and Optimizing Process Behavior Using Design of Experiments

This webinar will review the key concepts behind Design of Experiments. A strategy for utilizing sequential experiments to most efficiently understand and model a process is presented. Many common types of experiments and their applications are presented. These include experiments appropriate for screening, optimization, mixtures/formulations, etc. Several important techniques in experimental design (such as replication, blocking, and randomization) are introduced. A Case Study involving optimizing a manufacturing process with multiple responses is presented.

Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
Steven Wachs

Applying Statistical Process Control Effectively

Many companies have failed to achieve the potential benefits from the application of statistical process control due to widespread misunderstanding and misapplication of the methods. When misapplied, great improvements in quality and productivity are not achieved. The consequences of the improper application of SPC include: devastating inefficiencies, poor purchasing decisions, a false sense of reality, and processes controlling human behavior rather than the humans controlling process behavior.

Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
John C. Fetzer

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.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John C. Fetzer

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.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Gwendolyn Wise-Blackman

Auditing Laboratories Conducting Assays Supporting Biologics

Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits. Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.

Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Gwendolyn Wise-Blackman

Validation Challenges for Bioassays

Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.

Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John Ryan

NEW FDA Proposed FSMA Rule on Food Traceability

This 60-minute webinar will cover the proposed FDA traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls.

Speaker: John Ryan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Ginette Collazo

3-Hour Virtual Seminar on Human Error Reduction in GMP Related Environments

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

Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Ginette Collazo

How to write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Ginette Collazo

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.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Charles H. Paul

Preventing Human Error in the Life Sciences

This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

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).

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

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.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John Ryan

Standardizing Transportation Procedures to Control Food Safety and Quality

The course includes activities to help trainees develop a general plan and procedures to standardize and control food quality and safety transportation processes.

Speaker: John Ryan | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

Mobile Medical Apps(is it a FDA Regulated Device) and Cybersecurity

This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

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

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John Ryan

Carrier Food Safety Problems That May Occur during Transportation (FDA-FSMA)

The FDA recommended course includes actual data, costs and examples from transportation tracked and measured operations.

Speaker: John Ryan | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
David Ringstrom

Expedite Excel with Hidden Shortcuts

Excel expert David Ringstrom, CPA is fond of stating "Either you work Excel, or it works you!" In this fast-paced presentation David will share over two dozen ways that you can reclaim part of your day from Excel. You'll uncover mouse techniques, keyboard shortcuts, hidden menus, and even ways to create your own custom keyboard shortcuts in Excel.

Speaker: David Ringstrom | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
David Ringstrom

Master Excel: Excel Dashboards

In this informative webcast, Excel expert David H. Ringstrom, CPA, introduces you to the concept of Microsoft Excel dashboards.

Speaker: David Ringstrom | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Angela Bazigos

3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections

It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science".

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on Design Controls for Medical Devices

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on CAPA for Medical Devices

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Susanne Manz

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. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This webinar will help you avoid those struggles and establish an efficient and effective CAPA process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Michael Esposito

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.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John E Lincoln

EU ISO 13485:2016 Medical Device Quality Management System

This webinar will examine the basic elements of the EU's QMS, ISO 13485, how to implement, areas of major concern and regulatory expectations, and how the system works together. It will examine the underlying causes for major regulated medical device industry QMS failings, as well as how ISO 13485 interfaces with the EU MDR (Medical Device Regulation).

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John E Lincoln

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.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John E Lincoln

Project Management for FDA-Regulated Companies

This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John E Lincoln

Verification vs Validation-Product, Process or Equipment and QMS Software

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John E Lincoln

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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Steven Wachs

Useful Statistical Methods for Defining Product and Process Specifications

Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Steven Wachs

Sample Size Determination for Design Validation Activities

Design Validation should ensure that product performance, quality, and reliability requirements are met.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Steven Wachs

Determining Sample Size: What Sample Size Should I Use?

The webinar will provide important considerations when selecting sample sizes for specific applications.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Brenda Neckvatal

The Coronavirus in the Workplace

The circumstances surrounding the coronavirus are continuing to develop each day, and with the rapid-fire nature of the modern media, details vary from broadcast to broadcast, leaving the audience in fear and confused as to what next steps they should take. Having a plan is the best course of action, and with the changing national condition, employers are feeling the pressure of growing concern.

Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Martin K. Behr, III

Classifying Your Products for International Trade: Plain Talk and Understanding

Importers must know how to classify imported products using the Harmonized Tariff Schedule of the United States (HTSUS).

Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Martin K. Behr, III

Importing and Exporting Covid-19 Products

The outbreak of coronavirus disease (COVID-19), first in the People's Republic of China (PRC or China), and now globally, including in the United States, is drawing attention to the ways in which the United States and other economies depend on critical manufacturing and global value chains that rely on production based in in the PRC and other countries.

Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Martin K. Behr, III

INCOTERMS 2020 Made Easy - Decoding your Shipment

The term, Incoterms®, is an abbreviation for International Commercial Terms.

Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mike Thomas

Power BI - Calculations and Measures

This session follows on from "Power BI - Getting Started" and focuses on creating reports from multiple data sources, cleaning and transforming your data and creating Calculated Columns and Measures.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mike Thomas

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.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mike Thomas

Improving Productivity with The Office 365 Suite

As a basic-level user of Microsoft Office, you'd love to reduce the number of "hair-tearing-out" moments. You'd love to be able to do things faster so you can go home on time.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Mike Thomas

Excel - Using Macros to Automate Repetitive Tasks and Processes

Do you find yourself repeatedly performing the same actions or tasks in your spreadsheets? Do you have a time-consuming Excel-based process that you want to automate?

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Mike Thomas

Excel - The Business Intelligence Toolkit - Effective Data Visualization

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Karla Brandau

Outlook Tips and Techniques Survive an Avalanche of Emails

Is managing your Inbox and digging out from an avalanche of emails a full time job? Then sign up for this webinar and learn how to survive the heavy load of tasks and the constant stream of trivia that arrives via email.

Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Steven Wachs

Using Statistics to Determine Sample Size

We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.

Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John C. Fetzer

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.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Mike Thomas

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.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Teri C. Soli

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Tom Fragale

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.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Tom Fragale

Microsoft Excel- Advanced Charting

There's the famous saying, "A Picture is worth a thousand words". Well, that is very true in Microsoft Excel.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
David Ringstrom

Master Excel: Excel Dashboards

In this informative webcast, Excel expert David H. Ringstrom, CPA, introduces you to the concept of Microsoft Excel dashboards.

Speaker: David Ringstrom | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

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.

Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Casper Uldriks

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.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Casper Uldriks

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).

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Jeff Kasoff

How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Robert J. Russell

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.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Robert J. Russell

BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now

The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Jeff Kasoff

FDA Inspections - Do's and Don'ts

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Robert J. Russell

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.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Tom Fragale

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.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Michael Esposito

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.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Michael Esposito

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.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Writing Excellent SOPs

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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John E Lincoln

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.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
John E Lincoln

Verification vs Validation-Product, Process or Equipment and QMS Software

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Steven Wachs

Determining Sample Size: What Sample Size Should I Use?

The webinar will provide important considerations when selecting sample sizes for specific applications.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Gwendolyn Wise-Blackman

Validation Challenges for Bioassays

Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.

Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Yuval Shapiro

Cost of Quality from Theory to Implementation

How could one assess the effectiveness of a Quality Management System? The best way to do that, is by using the ultimate transfer unit: MONEY!

Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Steven Wachs

Sample Size Determination for Design Validation Activities

Design Validation should ensure that product performance, quality, and reliability requirements are met.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Eleonora Babayants

FDA Compliance for Mobile Applications

Attend this webinar to understand the FDA guidance for mobile applications.

Speaker: Eleonora Babayants | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

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

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) for FDA-Regulated Computers

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Yuval Shapiro

Risk Management - Implementing ISO14971: 2019

Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.

Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Martin K. Behr, III

Say Goodbye to NAFTA: The USMCA is Now Here

The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes.

Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Yuval Shapiro

Creating Optimal Sampling Plans

A sampling plan is a term widely used in research studies that provide an outline on the basis which of research is conducted. It tells which category is to be surveyed, what should be the sample size and how the respondents should be chosen out of the population.

Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Steven Wachs

Useful Statistical Methods for Defining Product and Process Specifications

Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
John C. Fetzer

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.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Edwin Waldbusser

Medical Device Risk Management following ISO 14971:2019

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post production risk management program be implemented.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory 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.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Charles H. Paul

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

This webinar 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.

Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Steven S Kuwahara

Test

Speaker: Steven S Kuwahara | View Anytime | Duration: 60 Minutes | Price: $2.00 | View Details
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