- 9
- December
- 2022
- Friday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 9
- December
- 2022
- Friday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 9
- December
- 2022
- Friday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 12
- December
- 2022
- Monday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 12
- December
- 2022
- Monday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 12
- December
- 2022
- Monday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 12
- December
- 2022
- Monday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 13
- December
- 2022
- Tuesday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 13
- December
- 2022
- Tuesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 13
- December
- 2022
- Tuesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 13
- December
- 2022
- Tuesday
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Tom Fragale |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 14
- December
- 2022
- Wednesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 14
- December
- 2022
- Wednesday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 14
- December
- 2022
- Wednesday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 14
- December
- 2022
- Wednesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 15
- December
- 2022
- Thursday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 15
- December
- 2022
- Thursday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 16
- December
- 2022
- Friday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 16
- December
- 2022
- Friday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 19
- December
- 2022
- Monday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 19
- December
- 2022
- Monday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 19
- December
- 2022
- Monday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 20
- December
- 2022
- Tuesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 20
- December
- 2022
- Tuesday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 20
- December
- 2022
- Tuesday
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 |
Duration: 2 Hours |
Price: $190.00
| View Details
- 20
- December
- 2022
- Tuesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 20
- December
- 2022
- Tuesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 21
- December
- 2022
- Wednesday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 21
- December
- 2022
- Wednesday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 21
- December
- 2022
- Wednesday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 21
- December
- 2022
- Wednesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 22
- December
- 2022
- Thursday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 22
- December
- 2022
- Thursday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 22
- December
- 2022
- Thursday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 23
- December
- 2022
- Friday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 5
- January
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 5
- January
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 6
- January
- 2023
- Friday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 6
- January
- 2023
- Friday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 9
- January
- 2023
- Monday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 10
- January
- 2023
- Tuesday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 10
- January
- 2023
- Tuesday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 10
- January
- 2023
- Tuesday
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 |
Duration: 3 Hours |
Price: $290.00
| View Details
- 10
- January
- 2023
- Tuesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 10
- January
- 2023
- Tuesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 11
- January
- 2023
- Wednesday
Excel: Tips and Tricks and Shortcuts
Microsoft Excel has become the de facto spreadsheet application for business.
Tom Fragale |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 11
- January
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 12
- January
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 12
- January
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 12
- January
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 12
- January
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 12
- January
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 13
- January
- 2023
- Friday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 13
- January
- 2023
- Friday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 16
- January
- 2023
- Monday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 17
- January
- 2023
- Tuesday
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 |
Duration: 75 Minutes |
Price: $150.00
| View Details
- 17
- January
- 2023
- Tuesday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 18
- January
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 18
- January
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 19
- January
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 19
- January
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 19
- January
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 19
- January
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 20
- January
- 2023
- Friday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 20
- January
- 2023
- Friday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 20
- January
- 2023
- Friday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 24
- January
- 2023
- Tuesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 24
- January
- 2023
- Tuesday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 24
- January
- 2023
- Tuesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 25
- January
- 2023
- Wednesday
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 |
Duration: 3 Hours |
Price: $290.00
| View Details
- 25
- January
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 25
- January
- 2023
- Wednesday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 25
- January
- 2023
- Wednesday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 25
- January
- 2023
- Wednesday
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 |
Duration: 3 Hours |
Price: $290.00
| View Details
- 26
- January
- 2023
- Thursday
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 |
Duration: 2 Hours |
Price: $190.00
| View Details
- 26
- January
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 26
- January
- 2023
- Thursday
Writing Excellent SOPs
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Susanne Manz |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 26
- January
- 2023
- Thursday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 26
- January
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 27
- January
- 2023
- Friday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 27
- January
- 2023
- Friday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 30
- January
- 2023
- Monday
Create and Run a Complete Slideshow in PowerPoint
PowerPoint has advanced to spectacular levels since its launch in 1990.
Roman Kondratiuk |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 31
- January
- 2023
- Tuesday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 1
- February
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 1
- February
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 2
- February
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 2
- February
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 2
- February
- 2023
- Thursday
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 |
Duration: 3 Hours |
Price: $290.00
| View Details
- 2
- February
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 2
- February
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 3
- February
- 2023
- Friday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 3
- February
- 2023
- Friday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 6
- February
- 2023
- Monday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 8
- February
- 2023
- Wednesday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 8
- February
- 2023
- Wednesday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 8
- February
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 9
- February
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 9
- February
- 2023
- Thursday
Essentials of Validation - IQ OQ PQ
Validation is an important element of the Quality System Regulations and ISO13485.
Susanne Manz |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 9
- February
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 10
- February
- 2023
- Friday
Excel - Power Query for the Everyday Excel User - Part 1
Turn bad data into great data in minutes!
Mike Thomas |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 14
- February
- 2023
- Tuesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 14
- February
- 2023
- Tuesday
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.
Duration: 60 Minutes | | View Details- 16
- February
- 2023
- Thursday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 16
- February
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 16
- February
- 2023
- Thursday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 21
- February
- 2023
- Tuesday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 21
- February
- 2023
- Tuesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 21
- February
- 2023
- Tuesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 22
- February
- 2023
- Wednesday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 24
- February
- 2023
- Friday
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 |
Duration: 6 Hours |
Price: $545.00
| View Details
- 27
- February
- 2023
- Monday
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 |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 27
- February
- 2023
- Monday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 28
- February
- 2023
- Tuesday
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 |
Duration: 4 Hours |
Price: $445.00
| View Details
- 28
- February
- 2023
- Tuesday
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 |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 8
- March
- 2023
- Wednesday
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 |
Duration: 75 Minutes |
Price: $150.00
| View Details
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