• 30
  • July
  • 2020
  • Monday
08:00 AM PDT | 11:00 AM EDT

Test

Steven S Kuwahara Steven S Kuwahara | Duration: 60 Minutes | Price: $1.00 | View Details
  • 13
  • November
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

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.

Roger Cowan Roger Cowan | Duration: 60 Minutes | Price: $149.00 | View Details
  • 14
  • November
  • 2024
  • Thursday
10:00 AM PST | 01:00 PM EST

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. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Robert J. Russell Robert J. Russell | Duration: 3 Hours | Price: $299.00 | View Details
  • 14 & 15
  • November
  • 2024
  • Thursday
08:00 AM PST | 11:00 AM EST

2-Day Virtual Seminar on Project Management for Non-Project Managers - PM in the Life Sciences - Pharmaceutical/ Biotechnology and Medical Devices

What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant.

Charles H. Paul Charles H. Paul | Duration: 2 Days | Price: $995.00 | View Details
  • 15
  • November
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 15
  • November
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

Strategies to Prevent Manufacture and Distribution of Substandard Medications

Substandard product can exist even if the product itself is manufactured according to quality standards. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 15
  • November
  • 2024
  • Friday
08:00 AM PST | 11:00 AM EST

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.

Carolyn Troiano Carolyn Troiano | Duration: 4 Hours | Price: $445.00 | View Details
  • 15
  • November
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 15
  • November
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

Excel Formula Functions & Automatic Calculation Powerpoint Easy

Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 15
  • November
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • November
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

Excel - Essential Tips and Tricks for the New User

Embark on a journey to spreadsheet proficiency with our comprehensive Excel training tailored for beginners. This expertly designed session is the perfect launchpad for individuals with a foundational understanding of spreadsheets who aspire to delve deeper.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • November
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 18
  • November
  • 2024
  • Monday
09:00 AM PST | 12:00 PM EST

3-Hour Virtual Seminar on Chat GPT for Project Management in FDA Regulated Environment

This comprehensive three-hour virtual seminar, titled "Mastering AI Integration in Project Management: Leveraging ChatGPT for Enhanced Efficiency and Compliance in FDA-Regulated Industries," is designed to provide project management professionals with a thorough understanding of the practical applications of AI tools like ChatGPT.

Charles H. Paul Charles H. Paul | Duration: 3 Hours | Price: $299.00 | View Details
  • 18
  • November
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 18
  • November
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

FDA Regulation of Artificial Intelligence/ Machine Learning

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

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • November
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

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. The process requirements and validation needs differ based on the filtration requirement.

Roger Cowan Roger Cowan | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • November
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • November
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 20
  • November
  • 2024
  • Wednesday
11:30 AM PST | 02:30 PM EST

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.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 20
  • November
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

Essentials of Validation - IQ OQ PQ

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

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 20
  • November
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

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.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 21
  • November
  • 2024
  • Thursday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot

In today's world, there are a ton of data to manage. Data is coming from many different sources.

Tom Fragale Tom Fragale | Duration: 4 Hours | Price: $445.00 | View Details
  • 21
  • November
  • 2024
  • Thursday
10:00 AM PST | 01:00 PM EST

Validation Sampling Plans, Setting Acceptance Specifications, and Statistical Process Control

Setting up an appropriate sampling plan for process and setting appropriate acceptance criteria is critical for successful validation activities.

Alan M Golden Alan M Golden | Duration: 60 Minutes | Price: $149.00 | View Details
  • 21
  • November
  • 2024
  • Thursday
10:00 AM PST | 01:00 PM EST

Using a Learning Management System (LMS) to Develop Pharma Training Curricula

Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 21 & 22
  • November
  • 2024
  • Thursday
08:00 AM PST | 11:00 AM EST

2-Day 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. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

Charles H. Paul Charles H. Paul | Duration: 2 Days | Price: $995.00 | View Details
  • 22
  • November
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

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.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 22
  • November
  • 2024
  • Friday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

John E Lincoln John E Lincoln | Duration: 6 Hours | Price: $545.00 | View Details
  • 25
  • November
  • 2024
  • Monday
08:30 AM PST | 11:30 AM EST

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.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • November
  • 2024
  • Tuesday
10:00 AM PST | 01:00 PM EST

Project Chartering and Primary Metrics - The Foundation for Successful Process Improvement

This session is designed to provide an understanding of the importance of project chartering and defining primary metrics as foundational steps for successful process improvement initiatives.

Jim Athon Jim Athon | Duration: 60 Minutes | Price: $149.00 | View Details
  • 26
  • November
  • 2024
  • Tuesday
10:00 AM PST | 01:00 PM EST

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. We will discuss how to determine the level of impact assessment needed for what type of changes and how to base this decision on risk.

Alan M Golden Alan M Golden | Duration: 60 Minutes | Price: $149.00 | View Details
  • 26
  • November
  • 2024
  • Tuesday
10:00 AM PST | 01:00 PM EST

How to Write SOPs for Human Error Reduction

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

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • November
  • 2024
  • Tuesday
10:00 AM PST | 01:00 PM EST

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats

This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • November
  • 2024
  • Tuesday
10:00 AM PST | 01:00 PM EST

Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities

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

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • November
  • 2024
  • Tuesday
11:30 AM PST | 02:30 PM EST

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.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • November
  • 2024
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 27
  • November
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

CMO Supplier Quality Agreements - What you need to know to Comply with New FDA & EU GMP 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.

Roger Cowan Roger Cowan | Duration: 60 Minutes | Price: $149.00 | View Details
  • 27
  • November
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

How to Deal with Bad Results Under GLP

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

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 27
  • November
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

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.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 29
  • November
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

Excel Power Pivot 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.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 29
  • November
  • 2024
  • Friday
08:00 AM PST | 11:00 AM EST

6-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.

Carolyn Troiano Carolyn Troiano | Duration: 6 Hours | Price: $545.00 | View Details
  • 2
  • December
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 2
  • December
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

Excel - Lists and Tables - A Beginner's Guide to Managing List-Based Data

Often perceived as a mere number-crunching tool, Excel's true prowess lies in its capacity to organize and manage list-based data efficiently and this training session is designed to unveil Excel's full potential beyond arithmetic computations.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 2
  • December
  • 2024
  • Monday
08:00 AM PST | 11:00 AM EST

6-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.

Carolyn Troiano Carolyn Troiano | Duration: 6 Hours | Price: $545.00 | View Details
  • 2
  • December
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

Function, Preparation, and Execution of Job Aids in the Pharmaceutical Industry

Job aids, also known as work instructions, are documents that resemble SOPs, but their content, use and training are different than those for SOPs.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 2
  • December
  • 2024
  • Monday
07:00 AM PST | 10:00 AM EST

6-Hour Virtual Seminar on Inspection and Audit Readiness Training for Medical Device Manufacturers

There has been a major shift in the emphasis of U.S. FDA CGMP compliance audits over the past few years.

John E Lincoln John E Lincoln | Duration: 6 Hours | Price: $545.00 | View Details
  • 4
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

3-Hour Virtual Seminar on IQ, OQ, and PQ in the Verification and Validation Process

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

Susanne Manz Susanne Manz | Duration: 3 Hours | Price: $299.00 | View Details
  • 4
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

Excel Vital Introductory Essentials with Tips & Shortcuts

This webinar effectively promotes a sound understanding of the Excel interface, features and capabilities incorporating hands-on practice, productivity tips and shortcuts.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 4
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 4
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

The Transfer of Validated Methods

This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 4
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

ChatGPT for Excel

This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 4
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

GMP Environmental Monitoring in Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room.

Roger Cowan Roger Cowan | Duration: 60 Minutes | Price: $149.00 | View Details
  • 4
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

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

This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.

David Nettleton David Nettleton | Duration: 90 Minutes | Price: $149.00 | View Details
  • 4
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

How to Write SOPs that Avoid Human Error

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

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 5
  • December
  • 2024
  • Thursday
10:00 AM PST | 01:00 PM EST

Scientific Writing Fundamentals - Mastering the Basics in Life Sciences Documentation

Scientific Writing Fundamentals - Mastering the Basics in Life Sciences Documentation is a dynamic and comprehensive 90-minute webinar designed to empower researchers, students, and professionals in the life sciences field with essential skills for effective written communication.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 5
  • December
  • 2024
  • Thursday
10:00 AM PST | 01:00 PM EST

The Monte Carlo Simulations in Excel for Risky Investments

This workshop is about understanding what is behind the Monte Carlo Simulation.

Isaac Gottlieb Isaac Gottlieb | Duration: 60 Minutes | Price: $149.00 | View Details
  • 6
  • December
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

How to Prepare for and Host an FDA Inspection and Respond to 483's

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 6
  • December
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

Excel - Mastering Lookup Functions

"How do I look up a value in list ONE and pick up a related value from list TWO"

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 6
  • December
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

US Market Access & Reimbursement: Medical Devices

This targeted 60-minute U.S. Reimbursement training/webinar will help you understand and navigate the complex U.S. system for understanding product reimbursement status and potential for your Medical Device.

Robert J. Russell Robert J. Russell | Duration: 60 Minutes | Price: $149.00 | View Details
  • 6
  • December
  • 2024
  • Friday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on Combination Product Device Supplier Management Training

There has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance.

John E Lincoln John E Lincoln | Duration: 4 Hours | Price: $445.00 | View Details
  • 9
  • December
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 9
  • December
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 9
  • December
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

The Importance of Packaging and Labeling in Pharmaceutical Product Development

Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 10
  • December
  • 2024
  • Tuesday
10:00 AM PST | 01:00 PM EST

Writing for Regulatory Success - Strategies for Quality Technical Documents

This 90-minute webinar is designed to provide professionals across various industries with a comprehensive understanding of the critical intersection between effective technical writing, regulatory compliance, and copyright considerations.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 10
  • December
  • 2024
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Mike Thomas Mike Thomas | Duration: 3 Hours | Price: $299.00 | View Details
  • 10
  • December
  • 2024
  • Tuesday
10:00 AM PST | 01:00 PM EST

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 it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 11
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

Excel Lookup Functions Xlookup & Error Suppression

Going "beyond the basics" Ray Evans clearly demonstrates, features and functionality that enhance the power and flexibility of lookup functions at intermediate level.

Ray Evans Ray Evans | Duration: 90 Minutes | Price: $149.00 | View Details
  • 11
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

Project Management for Non-Project Managers - Scheduling your Project

This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project's objectives.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 11
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

The Data Ribbon and PivotTables

The purpose of this workshop is to use the features of the data ribbon and the PivotTable of Excel for what we call datamining.

Isaac Gottlieb Isaac Gottlieb | Duration: 60 Minutes | Price: $149.00 | View Details
  • 11
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 12
  • December
  • 2024
  • Thursday
10:00 AM PST | 01:00 PM EST

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 13
  • December
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

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.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 13
  • December
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

Excel - Quick Tips to Help you be More Productive

Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 13
  • December
  • 2024
  • Friday
08:00 AM PST | 11:00 AM EST

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.

Carolyn Troiano Carolyn Troiano | Duration: 4 Hours | Price: $445.00 | View Details
  • 13
  • December
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

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. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Robert J. Russell Robert J. Russell | Duration: 3 Hours | Price: $299.00 | View Details
  • 13
  • December
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

Strategies to Prevent Manufacture and Distribution of Substandard Medications

Substandard product can exist even if the product itself is manufactured according to quality standards. Harm to patients and damage to a company's reputation are the two most obvious consequences of substandard product.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 16
  • December
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

Preventing Human Error in the Life Sciences

This webinar will describe the nature of human error in terms of how it is manifest and it distinct properties.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 16
  • December
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

Excel Basics - Data Visualization - Creating Effective Charts

"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 16
  • December
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

FDA Regulation of Artificial Intelligence/ Machine Learning

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

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 16
  • December
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

Using a Learning Management System (LMS) to Develop Pharma Training Curricula

Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 16
  • December
  • 2024
  • Monday
08:00 AM PST | 11:00 AM EST

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.

Tom Fragale Tom Fragale | Duration: 4 Hours | Price: $445.00 | View Details
  • 16
  • December
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

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.

John E Lincoln John E Lincoln | Duration: 3 Hours | Price: $299.00 | View Details
  • 16
  • December
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

Introduction to Excel's Built-In Solver - Advanced Decision-Making Tools

Solver is a Microsoft Excel add-in program you can use for what-if analysis. Use Solver to find an optimal (maximum or minimum) value for a formula in one cell - called the objective cell - subject to constraints, or limits, on the values of other formula cells on a worksheet.

Isaac Gottlieb Isaac Gottlieb | Duration: 60 Minutes | Price: $149.00 | View Details
  • 16
  • December
  • 2024
  • Monday
10:00 AM PST | 01:00 PM EST

US, EU, Japan GMP Requirements

This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 17
  • December
  • 2024
  • Tuesday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and the Future

One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.

John E Lincoln John E Lincoln | Duration: 4 Hours | Price: $445.00 | View Details
  • 17
  • December
  • 2024
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

FDA Audit Best Practices - Do's and Don'ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 18
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • December
  • 2024
  • Wednesday
10:00 AM PST | 01:00 PM EST

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 19
  • December
  • 2024
  • Thursday
10:00 AM PST | 01:00 PM EST

How to Deal with Bad Results Under GLP

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

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 19
  • December
  • 2024
  • Thursday
10:00 AM PST | 01:00 PM EST

Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities

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

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 20
  • December
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats

This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently.

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 20
  • December
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

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.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • December
  • 2024
  • Friday
10:00 AM PST | 01:00 PM EST

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.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • December
  • 2024
  • Friday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and the Future

One of our most popular seminars, continuously updated with the latest U.S. FDA and European Union requirements. Now expanded to a 4-hour format. As U.S. companies go global, they must meet different product design documentation.

John E Lincoln John E Lincoln | Duration: 4 Hours | Price: $445.00 | View Details
  • 23
  • January
  • 2025
  • Thursday
10:00 AM PST | 01:00 PM EST

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

This interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s.

David Nettleton David Nettleton | Duration: 75 Minutes | Price: $149.00 | View Details
  • 6
  • February
  • 2025
  • Thursday
10:00 AM PST | 01:00 PM EST

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

This Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure.

David Nettleton David Nettleton | Duration: 2 Hours | Price: $199.00 | View Details
  • 11
  • March
  • 2025
  • Tuesday
10:00 AM PST | 01:00 PM EST

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

This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.

David Nettleton David Nettleton | Duration: 90 Minutes | Price: $149.00 | View Details
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