• 2
  • December
  • 2022
  • 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
  • 6
  • December
  • 2022
  • Tuesday
08:00 AM PST | 11:00 AM EST

6-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.

Charles H. Paul Charles H. Paul | Duration: 6 Hours | Price: $545.00 | View Details
  • 7
  • December
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 7
  • December
  • 2022
  • 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: 60 Minutes | Price: $149.00 | View Details
  • 7
  • December
  • 2022
  • Wednesday
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. 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.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 7
  • December
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

CAPA: Corrective and Preventative Actions and Non-Conformances

If instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it.

Michael Brodsky Michael Brodsky | Duration: 60 Minutes | Price: $149.00 | View Details
  • 8
  • December
  • 2022
  • 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 2-Hour Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

David Nettleton David Nettleton | Duration: 2 Hours | Price: $199.00 | View Details
  • 8
  • December
  • 2022
  • Thursday
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
  • 9
  • December
  • 2022
  • Friday
08:00 AM PST | 11:00 AM EST

6-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.

Casper Uldriks Casper Uldriks | Duration: 6 Hours | Price: $545.00 | View Details
  • 9
  • December
  • 2022
  • 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
  • 9
  • December
  • 2022
  • Friday
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. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 12
  • December
  • 2022
  • Monday
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
  • 12
  • December
  • 2022
  • Monday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.

Michael Esposito Michael Esposito | Duration: 4 Hours | Price: $445.00 | View Details
  • 12
  • December
  • 2022
  • Monday
10:00 AM PST | 01:00 PM EST

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.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 12
  • December
  • 2022
  • Monday
09:00 AM PST | 12:00 PM EST

Mastering Data and Information Management Essentials

Skills to effectively manage, present and communicate data are now vital in the competitive financial and business analysis fields and offer vast opportunities to expand accounting client services and career paths.

Roman Kondratiuk Roman Kondratiuk | Duration: 90 Minutes | Price: $149.00 | View Details
  • 13
  • December
  • 2022
  • Tuesday
08:00 AM PST | 11:00 AM EST

6-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.

Charles H. Paul Charles H. Paul | Duration: 6 Hours | Price: $545.00 | View Details
  • 13
  • December
  • 2022
  • Tuesday
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
  • 13
  • December
  • 2022
  • Tuesday
10:00 AM PST | 01:00 PM EST

European Union Device Regulation (EU MDR)

The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 13
  • December
  • 2022
  • Tuesday
10:00 AM PST | 01:00 PM EST

Excel: Tips and Tricks and Shortcuts

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

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 14
  • December
  • 2022
  • Wednesday
08:00 AM PST | 11:00 AM EST

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.

Joy McElroy Joy McElroy | Duration: 4 Hours | Price: $445.00 | View Details
  • 14
  • December
  • 2022
  • 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
  • 14
  • December
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software

Advancements in technology have forced organizations to rethink business models.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 14
  • December
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

Is it Microbiological Method Verification or Validation, or Just Semantics?

This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation in food/water microbiology. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses.

Michael Brodsky Michael Brodsky | Duration: 60 Minutes | Price: $149.00 | View Details
  • 15
  • December
  • 2022
  • Thursday
10:00 AM PST | 01:00 PM EST

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.

Dennis Taylor Dennis Taylor | Duration: 60 Minutes | Price: $149.00 | View Details
  • 15
  • December
  • 2022
  • Thursday
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
  • 16
  • December
  • 2022
  • Friday
08:00 AM PST | 11:00 AM EST

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

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

Robert J. Russell Robert J. Russell | Duration: 6 Hours | Price: $545.00 | View Details
  • 16
  • December
  • 2022
  • Friday
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: 60 Minutes | Price: $149.00 | View Details
  • 19
  • December
  • 2022
  • Monday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.

Robert J. Russell Robert J. Russell | Duration: 4 Hours | Price: $445.00 | View Details
  • 19
  • December
  • 2022
  • Monday
10:00 AM PST | 01:00 PM EST

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.

Susanne Manz Susanne Manz | Duration: 60 Minutes | Price: $149.00 | View Details
  • 19
  • December
  • 2022
  • Monday
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: 60 Minutes | Price: $149.00 | View Details
  • 20
  • December
  • 2022
  • Tuesday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar - Batch Record Review and Product Release

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.

Danielle DeLucy Danielle DeLucy | Duration: 6 Hours | Price: $545.00 | View Details
  • 20
  • December
  • 2022
  • Tuesday
10:00 AM PST | 01:00 PM EST

2-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.

Dennis Taylor Dennis Taylor | Duration: 2 Hours | Price: $199.00 | View Details
  • 20
  • December
  • 2022
  • Tuesday
10:00 AM PST | 01:00 PM EST

Excel - Creating an Interactive Dashboard

No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it's flexibility, and the fact that most people have it installed on their computers.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • December
  • 2022
  • Tuesday
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. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • December
  • 2022
  • Tuesday
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
  • 21
  • December
  • 2022
  • Wednesday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices, etc.)

This seminar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance.

Joy McElroy Joy McElroy | Duration: 6 Hours | Price: $545.00 | View Details
  • 21
  • December
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

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 SOPs to reduce the likelihood of human errors.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 21
  • December
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

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.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 21
  • December
  • 2022
  • Wednesday
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
  • December
  • 2022
  • Thursday
08:00 AM PST | 11:00 AM EST

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.

Susanne Manz Susanne Manz | Duration: 4 Hours | Price: $445.00 | View Details
  • 22
  • December
  • 2022
  • Thursday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

Tom Fragale Tom Fragale | Duration: 6 Hours | Price: $545.00 | View Details
  • 22
  • December
  • 2022
  • Thursday
08:00 AM PST | 11:00 AM EST

6-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.

Dennis Taylor Dennis Taylor | Duration: 6 Hours | Price: $545.00 | View Details
  • 23
  • December
  • 2022
  • 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
  • 5
  • January
  • 2023
  • Thursday
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
  • 5
  • January
  • 2023
  • Thursday
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
  • 6
  • January
  • 2023
  • Friday
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
  • 6
  • January
  • 2023
  • Friday
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: 60 Minutes | Price: $149.00 | View Details
  • 9
  • January
  • 2023
  • Monday
10:00 AM PST | 01:00 PM EST

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

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

Robert J. Russell Robert J. Russell | Duration: 6 Hours | Price: $545.00 | View Details
  • 10
  • January
  • 2023
  • Tuesday
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
  • 10
  • January
  • 2023
  • Tuesday
09:00 AM PST | 12:00 PM EST

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

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.

Susanne Manz Susanne Manz | Duration: 3 Hours | Price: $299.00 | View Details
  • 10
  • January
  • 2023
  • Tuesday
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
  • 10
  • January
  • 2023
  • Tuesday
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
  • 10
  • January
  • 2023
  • Tuesday
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
  • 11
  • January
  • 2023
  • Wednesday
10:00 AM PST | 01:00 PM EST

Excel: Tips and Tricks and Shortcuts

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

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 11
  • January
  • 2023
  • 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
  • 12
  • January
  • 2023
  • Thursday
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
  • 12
  • January
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

CAPA: Corrective and Preventative Actions and Non-Conformances

If instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it.

Michael Brodsky Michael Brodsky | Duration: 60 Minutes | Price: $149.00 | View Details
  • 12
  • January
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

The Human Error Tool Box: 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
  • 12
  • January
  • 2023
  • Thursday
09:00 AM PST | 12:00 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"

Roman Kondratiuk Roman Kondratiuk | Duration: 60 Minutes | Price: $149.00 | View Details
  • 12
  • January
  • 2023
  • Thursday
09:00 AM PST | 12:00 PM EST

Data Integrity and Privacy: 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
  • 13
  • January
  • 2023
  • Friday
10:00 AM PST | 01:00 PM EST

4-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated.

Robert J. Russell Robert J. Russell | Duration: 4 Hours | Price: $445.00 | View Details
  • 13
  • January
  • 2023
  • Friday
10:00 AM PST | 01:00 PM EST

6-Hour Virtual Seminar on Audit like the FDA

This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.

Susanne Manz Susanne Manz | Duration: 6 Hours | Price: $545.00 | View Details
  • 16
  • January
  • 2023
  • Monday
09:00 AM PST | 12:00 PM EST

Formulas Automatic Calculation and Key Functions in Excel

Understand and work effectively with fundamental and versatile calculation and analysis techniques in Excel at the introductory level.

Roman Kondratiuk Roman Kondratiuk | Duration: 90 Minutes | Price: $149.00 | View Details
  • 17
  • January
  • 2023
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Charles H. Paul Charles H. Paul | Duration: 4 Hours | Price: $445.00 | View Details
  • 17
  • January
  • 2023
  • Tuesday
10:00 AM PST | 01:00 PM EST

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

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

David Nettleton David Nettleton | Duration: 75 Minutes | Price: $149.00 | View Details
  • 18
  • January
  • 2023
  • Wednesday
10:00 AM PST | 01:00 PM EST

Is it Microbiological Method Verification or Validation, or Just Semantics?

This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation in food/water microbiology. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses.

Michael Brodsky Michael Brodsky | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • January
  • 2023
  • Wednesday
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. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 19
  • January
  • 2023
  • Thursday
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
  • 19
  • January
  • 2023
  • Thursday
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
  • 19
  • January
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 19
  • January
  • 2023
  • Thursday
09:00 AM PST | 12:00 PM EST

Mastering Chart and Graph Essentials in Excel

Imagine impressing your team, executives, and clients with your new skills, presenting data visually in engaging professional charts!

Roman Kondratiuk Roman Kondratiuk | Duration: 90 Minutes | Price: $149.00 | View Details
  • 20
  • January
  • 2023
  • Friday
10:00 AM PST | 01:00 PM EST

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.

Tom Fragale Tom Fragale | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • January
  • 2023
  • Friday
10:00 AM PST | 01:00 PM EST

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.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • January
  • 2023
  • 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
  • 24
  • January
  • 2023
  • Tuesday
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
  • 24
  • January
  • 2023
  • Tuesday
10:00 AM PST | 01:00 PM EST

Medical Device Hazard analysis following ISO 14971

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

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 24
  • January
  • 2023
  • Tuesday
10:00 AM PST | 01:00 PM 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
  • January
  • 2023
  • Wednesday
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
  • 25
  • January
  • 2023
  • Wednesday
10:00 AM PST | 01:00 PM EST

Controlling Human Error in the Manufacturing Floor

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 25
  • January
  • 2023
  • Wednesday
10:00 AM PST | 01:00 PM EST

6-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.

Charles H. Paul Charles H. Paul | Duration: 6 Hours | Price: $545.00 | View Details
  • 25
  • January
  • 2023
  • Wednesday
09:00 AM PST | 12:00 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
  • 25
  • January
  • 2023
  • Wednesday
09:00 AM PST | 12:00 PM EST

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

Verification and validation requirements have always been part of the US FDA’s GMPs. Yet companies still struggle with the performance of and documentation of Equipment, Process, Software, and quality management system validations.

John E Lincoln John E Lincoln | Duration: 3 Hours | Price: $299.00 | View Details
  • 26
  • January
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

Verification or Validation of Methods in Food Microbiology

Although method validation and method verification are related terms, they have very different analytical and statistical requirements, particularly for compliance with ISO/IEC 17025:2005. Unfortunately, the terms are often incorrectly used interchangeably, resulting in confusion and the application of inappropriate or inadequate analytical evaluations.

Michael Brodsky Michael Brodsky | Duration: 60 Minutes | Price: $149.00 | View Details
  • 26
  • January
  • 2023
  • Thursday
09:00 AM PST | 12:00 PM EST

Writing Excellent SOPs

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

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • January
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

4-Hour Virtual Seminar on The Interplay of the Americans With Disabilities Act, the Family and Medical Leave Act, and Workers Compensation

The Americans with Disabilities Act (ADA) prohibits discrimination against applicants and employees who are "qualified individuals with a disability."

Diane L. Dee Diane L. Dee | Duration: 4 Hours | Price: $445.00 | View Details
  • 26
  • January
  • 2023
  • Thursday
09:00 AM PST | 12:00 PM EST

Pivot Table Essentials for Data Analytics in Excel

A PivotTable displays a summary of a selected data set in a condensed format of rows, columns, data fields, and pages. These components can be "pivoted" with your mouse allowing you to expand, isolate, calculate, and group the particular data in real-time. This table empowers the user to view and analyze large amounts of information.

Roman Kondratiuk Roman Kondratiuk | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • January
  • 2023
  • 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 2-Hour Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

David Nettleton David Nettleton | Duration: 2 Hours | Price: $199.00 | View Details
  • 27
  • January
  • 2023
  • Friday
10:00 AM PST | 01:00 PM 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
  • 27
  • January
  • 2023
  • Friday
10:00 AM PST | 01:00 PM EST

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.

Susanne Manz Susanne Manz | Duration: 4 Hours | Price: $445.00 | View Details
  • 30
  • January
  • 2023
  • Monday
09:00 AM PST | 12:00 PM EST

Create and Run a Complete Slideshow in PowerPoint

PowerPoint has advanced to spectacular levels since its launch in 1990.

Roman Kondratiuk Roman Kondratiuk | Duration: 90 Minutes | Price: $149.00 | View Details
  • 31
  • January
  • 2023
  • Tuesday
10:00 AM PST | 01:00 PM 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
  • 1
  • February
  • 2023
  • Wednesday
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
  • 1
  • February
  • 2023
  • Wednesday
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. 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.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 2
  • February
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

ISO-IEC 17025:2017 Update Introduction: Everything Old is New Again

Many laboratories have successfully developed and implemented a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs.

Michael Brodsky Michael Brodsky | Duration: 90 Minutes | Price: $149.00 | View Details
  • 2
  • February
  • 2023
  • Thursday
09:00 AM PST | 12:00 PM EST

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. This 3-hour seminar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer-focused and ensure product quality and consistency. An effective and efficient design control process results in a predictable product development process with improved quality and compliance results. This seminar can help you create a design control process that is a competitive strength for your company.

Susanne Manz Susanne Manz | Duration: 3 Hours | Price: $299.00 | View Details
  • 2
  • February
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

Validation of HPLC/UPLC Methodologies

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 2
  • February
  • 2023
  • Thursday
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
  • 2
  • February
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

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.

Mike Thomas Mike Thomas | Duration: 90 Minutes | Price: $149.00 | View Details
  • 3
  • February
  • 2023
  • Friday
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
  • 3
  • February
  • 2023
  • Friday
10:00 AM PST | 01:00 PM EST

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.

John E Lincoln John E Lincoln | Duration: 60 Minutes | Price: $149.00 | View Details
  • 6
  • February
  • 2023
  • Monday
10:00 AM PST | 01:00 PM EST

4-Hour Virtual Seminar on Improving Your CAPA Program - And preparing for upcoming changes to the Quality System Regulation

The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This seminar will help you prepare for upcoming changes to the QSR and improve your CAPA process.

Susanne Manz Susanne Manz | Duration: 4 Hours | Price: $445.00 | View Details
  • 8
  • February
  • 2023
  • Wednesday
10:00 AM PST | 01:00 PM EST

6-Hour Virtual Seminar on Bootcamp on Excel

In this seminar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

Tom Fragale Tom Fragale | Duration: 6 Hours | Price: $545.00 | View Details
  • 8
  • February
  • 2023
  • Wednesday
10:00 AM PST | 01:00 PM EST

Risk based Computer System Validation

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

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 8
  • February
  • 2023
  • Wednesday
10:00 AM PST | 01:00 PM EST

Data Integrity and Privacy: 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
  • 9
  • February
  • 2023
  • Thursday
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
  • 9
  • February
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

Dealing with Difficult Customers Effectively

People and communications skills are very important in dealing with customers, but have little connection to doing good lab work. This webinar points out some approaches and skills to connect the two areas.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 9
  • February
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

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.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 10
  • February
  • 2023
  • Friday
10:00 AM PST | 01:00 PM EST

Excel - Power Query for the Everyday Excel User - Part 1

Turn bad data into great data in minutes!

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 14
  • February
  • 2023
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 14
  • February
  • 2023
  • Tuesday
10:00 AM PST | 01:00 PM EST

Excel - Creating an Interactive Dashboard

No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel is commonly used due to its power, it's flexibility, and the fact that most people have it installed on their computers.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 16
  • February
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

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.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 16
  • February
  • 2023
  • 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. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 16
  • February
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

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 SOPs to reduce the likelihood of human errors.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 21
  • February
  • 2023
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Susanne Manz Susanne Manz | Duration: 60 Minutes | Price: $149.00 | View Details
  • 21
  • February
  • 2023
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 21
  • February
  • 2023
  • Tuesday
10:00 AM PST | 01:00 PM EST

The Most Common Problems in FDA Software Verification and Validation

Software and related hardware design, development, verification, and validation are difficult to manage, document and control. This presentation focuses on the verification and validation planning and execution of software, after basic developmental testing and debugging. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 22
  • February
  • 2023
  • Wednesday
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
  • 24
  • February
  • 2023
  • Friday
10:00 AM PST | 01:00 PM EST

6-Hour Virtual Seminar on Purchasing and Supplier Controls

This 6-hour virtual seminar can help you understand your responsibilities in terms of Purchasing Controls and Supplier Management enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls! This virtual seminar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control.

Susanne Manz Susanne Manz | Duration: 6 Hours | Price: $545.00 | View Details
  • 27
  • February
  • 2023
  • Monday
10:00 AM PST | 01:00 PM EST

21 CFR Part 11 Conformance for Medical Devices

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. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 27
  • February
  • 2023
  • Monday
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: 90 Minutes | Price: $149.00 | View Details
  • 28
  • February
  • 2023
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 28
  • February
  • 2023
  • 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
  • 8
  • March
  • 2023
  • Wednesday
10:00 AM PST | 01:00 PM EST

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

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

David Nettleton David Nettleton | Duration: 75 Minutes | Price: $149.00 | View Details
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