• 11
  • January
  • 2022
  • Tuesday
11:00 AM PST | 02:00 PM EST

Mobile Apps as Medial Devices

Some of these new mobile apps / software functions are specifically targeted to assisting individuals in their own health and wellness management.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 20
  • January
  • 2022
  • Thursday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar on Bootcamp on Excel

In this webinar, 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
  • 20
  • January
  • 2022
  • 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
  • 21
  • January
  • 2022
  • Friday
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
  • 21
  • January
  • 2022
  • Friday
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
  • 21
  • January
  • 2022
  • Friday
08:00 AM PST | 11:00 AM EST

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

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

Elaine Eisenbeisz Elaine Eisenbeisz | Duration: 6 Hours | Price: $545.00 | View Details
  • 21
  • January
  • 2022
  • Friday
08:00 AM PST | 11:00 AM EST

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

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

John E Lincoln John E Lincoln | Duration: 6 Hours | Price: $545.00 | View Details
  • 21
  • January
  • 2022
  • Friday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar on Combination Products

This seminar provides Professionals working in this area with:

Salma Michor Salma Michor | Duration: 60 Minutes | Price: $545.00 | View Details
  • 24
  • January
  • 2022
  • Monday
11:00 AM PST | 02:00 PM EST

Good Manufacturing Practices (GMP) - An Introduction

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

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 24
  • January
  • 2022
  • Monday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar on 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: 6 Hours | Price: $545.00 | View Details
  • 25
  • January
  • 2022
  • Tuesday
08:00 AM PST | 11:00 AM EST

6-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: 6 Hours | Price: $545.00 | View Details
  • 25
  • January
  • 2022
  • Tuesday
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
  • 25
  • January
  • 2022
  • Tuesday
11:00 AM PST | 02:00 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. Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025. Understanding these differences is essential for developing appropriate strategies for assessing a method’s fitness for purpose.

Michael Brodsky Michael Brodsky | Duration: 60 Minutes | Price: $149.00 | View Details
  • 25
  • January
  • 2022
  • Tuesday
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
  • 25
  • January
  • 2022
  • Tuesday
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
  • 25
  • January
  • 2022
  • Tuesday
11:00 AM PST | 02:00 PM EST

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

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

John E Lincoln John E Lincoln | Duration: 3 Hours | Price: $299.00 | View Details
  • 25
  • January
  • 2022
  • Tuesday
11:00 AM PST | 02:00 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
  • 26
  • January
  • 2022
  • Wednesday
11:00 AM PST | 02:00 PM EST

Mandating COVID Vaccines at Work

The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.

Brenda Neckvatal Brenda Neckvatal | Duration: 60 Minutes | Price: $145.00 | View Details
  • 26
  • January
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

ISO13485: 2016 - Quality Management Systems for Medical Devices

This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.

Yuval Shapiro Yuval Shapiro | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • January
  • 2022
  • Wednesday
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
  • 27
  • January
  • 2022
  • Thursday
10:00 AM PST | 01:00 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
  • 27
  • January
  • 2022
  • 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
  • 27
  • January
  • 2022
  • Thursday
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
  • 27
  • January
  • 2022
  • Thursday
10:00 AM PST | 01:00 PM EST

How Will FDA's New Approach to CSV Make Implementations Easier?

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 28
  • January
  • 2022
  • Friday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar - The New EU Medical Device Regulation

In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices.

Salma Michor Salma Michor | Duration: 6 Hours | Price: $545.00 | View Details
  • 28
  • January
  • 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
  • 28
  • January
  • 2022
  • Friday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar on Statistics for Process Control

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

Elaine Eisenbeisz Elaine Eisenbeisz | Duration: 6 Hours | Price: $545.00 | View Details
  • 31
  • January
  • 2022
  • Monday
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 webinar 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
  • 1
  • February
  • 2022
  • Tuesday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar on Validation and 21 CFR Part 11 Compliance of Computer Systems

This course is appropriate for beginner and experienced person alike.

Angela Bazigos Angela Bazigos | Duration: 6 Hours | Price: $545.00 | View Details
  • 1
  • February
  • 2022
  • 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 webinars, 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
  • 2
  • February
  • 2022
  • Wednesday
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 Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

Carolyn Troiano Carolyn Troiano | Duration: 6 Hours | Price: $545.00 | View Details
  • 2
  • February
  • 2022
  • Wednesday
08:00 AM PST | 11:00 AM EST

6-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: 6 Hours | Price: $545.00 | View Details
  • 2
  • February
  • 2022
  • 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
  • 2
  • February
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

Controlling Human Error in the Manufacturing Floor

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
  • 3
  • February
  • 2022
  • Thursday
08:00 AM PST | 11:00 AM 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
  • 3
  • February
  • 2022
  • Thursday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Peggy Berry Peggy Berry | Duration: 6 Hours | Price: $545.00 | View Details
  • 3
  • February
  • 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 webinar 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
  • 4
  • February
  • 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
  • 4
  • February
  • 2022
  • Friday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on How to Write Better Communications and Emails

Good leaders walk the talk, but they also write right. They know how to say in a few words what needs to be said in crisp, clear language.

Dev Strischek Dev Strischek | Duration: 4 Hours | Price: $445.00 | View Details
  • 4
  • February
  • 2022
  • Friday
10:00 AM PST | 01:00 PM EST

GMP Environmental Monitoring for 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
  • 7
  • February
  • 2022
  • Monday
08:00 AM PST | 11:00 AM EST

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

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

Eleonora Babayants Eleonora Babayants | Duration: 6 Hours | Price: $545.00 | View Details
  • 7
  • February
  • 2022
  • Monday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on Statistical Process Control (SPC) Boot Camp

Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to "listen" to their processes so that potentially harmful changes will be quickly detected and rectified.

Steven Wachs Steven Wachs | Duration: 4 Hours | Price: $445.00 | View Details
  • 7
  • February
  • 2022
  • Monday
10:00 AM PST | 01:00 PM EST

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

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

Charles H. Paul Charles H. Paul | Duration: 3 Hours | Price: $299.00 | View Details
  • 8
  • February
  • 2022
  • Tuesday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties

The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc.

Angela Bazigos Angela Bazigos | Duration: 4 Hours | Price: $445.00 | View Details
  • 8
  • February
  • 2022
  • Tuesday
08:00 AM PST | 11:00 AM EST

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

This webinar 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: 4 Hours | Price: $445.00 | View Details
  • 8
  • February
  • 2022
  • 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
  • 8
  • February
  • 2022
  • Tuesday
10:00 AM PST | 01:00 PM EST

Time-Saving Excel Tips, Tricks and 100 Shortcuts

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

Dennis Taylor Dennis Taylor | Duration: 60 Minutes | Price: $149.00 | View Details
  • 8
  • February
  • 2022
  • Tuesday
11:00 AM PST | 02:00 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
  • February
  • 2022
  • Wednesday
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
  • 9
  • February
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

Responsibility for Off-label Claims in Social Media

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

Casper Uldriks Casper Uldriks | Duration: 60 Minutes | Price: $149.00 | View Details
  • 9
  • February
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

HPLC Analytical Method Development and Validation

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

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 9
  • February
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

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

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

Michael Esposito Michael Esposito | Duration: 90 Minutes | Price: $149.00 | View Details
  • 9
  • February
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

Medical Device Cybersecurity and FDA Compliance

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 9
  • February
  • 2022
  • Wednesday
11:00 AM PST | 02:00 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
  • 10
  • February
  • 2022
  • Thursday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on Phase I GMPs

Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy subjects and use lower doses of the drug product.

Peggy Berry Peggy Berry | Duration: 4 Hours | Price: $445.00 | View Details
  • 10
  • February
  • 2022
  • Thursday
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
  • 10
  • February
  • 2022
  • Thursday
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
  • 11
  • February
  • 2022
  • Friday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on Combination Products

This seminar provides Professionals working in this area with:

Salma Michor Salma Michor | Duration: 4 Hours | Price: $445.00 | View Details
  • 14
  • February
  • 2022
  • Monday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on 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: 4 Hours | Price: $445.00 | View Details
  • 14
  • February
  • 2022
  • Monday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on 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
  • 14
  • February
  • 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
  • 15
  • February
  • 2022
  • Tuesday
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 webinar 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
  • 16
  • February
  • 2022
  • Wednesday
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
  • 16
  • February
  • 2022
  • Wednesday
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
  • 16
  • February
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

Medical Device Software Cybersecurity and IEC 62304 Compliance

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 16
  • February
  • 2022
  • Wednesday
11:00 AM PST | 02:00 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
  • 18
  • February
  • 2022
  • Friday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar on Statistics for Process Control

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

Elaine Eisenbeisz Elaine Eisenbeisz | Duration: 6 Hours | Price: $545.00 | View Details
  • 18
  • February
  • 2022
  • Friday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar - The New EU Medical Device Regulation

In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices.

Salma Michor Salma Michor | Duration: 6 Hours | Price: $545.00 | View Details
  • 18
  • February
  • 2022
  • Friday
11:00 AM PST | 02:00 PM EST

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

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

Jeff Kasoff Jeff Kasoff | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • February
  • 2022
  • Friday
10:00 AM PST | 01:00 PM EST

Project Management for Non-Project Managers - Determining your stakeholders - a stakeholder analysis, and why is it important?

This 90-minute webinar will walk you through the stakeholder analysis and the strategies that must be employed to manage your stakeholders effectively.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 21
  • February
  • 2022
  • Monday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on Bootcamp on Excel

In this webinar, 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
  • 21
  • February
  • 2022
  • Monday
10:00 AM PST | 01:00 PM EST

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

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

Mike Thomas Mike Thomas | Duration: 3 Hours | Price: $299.00 | View Details
  • 21
  • February
  • 2022
  • Monday
10:00 AM PST | 01:00 PM EST

Trends in FDA Compliance and Enforcement for Regulated Systems

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: 90 Minutes | Price: $149.00 | View Details
  • 22
  • February
  • 2022
  • Tuesday
10:00 AM PST | 01:00 PM EST

FDA's New Import Program for 2022 and Impact of the COVID-19

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

Casper Uldriks Casper Uldriks | Duration: 60 Minutes | Price: $149.00 | View Details
  • 22
  • February
  • 2022
  • 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
  • 22
  • February
  • 2022
  • Tuesday
10:00 AM PST | 01:00 PM EST

Mastering Excel Pivot Tables

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

Dennis Taylor Dennis Taylor | Duration: 60 Minutes | Price: $149.00 | View Details
  • 23
  • February
  • 2022
  • Wednesday
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
  • 23
  • February
  • 2022
  • 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 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
  • 23
  • February
  • 2022
  • Wednesday
09:00 AM PST | 12:00 PM EST

2- 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: 2 Hours | Price: $199.00 | View Details
  • 23
  • February
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

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

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

Charles H. Paul Charles H. Paul | Duration: 60 Minutes | Price: $149.00 | View Details
  • 24
  • February
  • 2022
  • Thursday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar on 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: 4 Hours | Price: $445.00 | View Details
  • 24
  • February
  • 2022
  • Thursday
08:00 AM PST | 11:00 AM EST

6-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: 6 Hours | Price: $545.00 | View Details
  • 25
  • February
  • 2022
  • Friday
08:00 AM PST | 11:00 AM EST

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

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

Elaine Eisenbeisz Elaine Eisenbeisz | Duration: 4 Hours | Price: $445.00 | View Details
  • 25
  • February
  • 2022
  • Friday
08:00 AM PST | 11:00 AM EST

6-Hour Virtual Seminar on Auditing Analytical Laboratories for FDA Compliance

There are two phases to this topic. The first is auditing itself. Good audits are well structured.

Steven S Kuwahara Steven S Kuwahara | Duration: 6 Hours | Price: $545.00 | View Details
  • 25
  • February
  • 2022
  • Friday
11:00 AM PST | 02:00 PM EST

FDA Inspections - Do's and Don'ts

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

Jeff Kasoff Jeff Kasoff | Duration: 60 Minutes | Price: $149.00 | View Details
  • 28
  • February
  • 2022
  • Monday
10:00 AM PST | 01:00 PM EST

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

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

Casper Uldriks Casper Uldriks | Duration: 3 Hours | Price: $299.00 | View Details
  • 28
  • February
  • 2022
  • Monday
09:00 AM PST | 12:00 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 be implemented.

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 28
  • February
  • 2022
  • Monday
09:00 AM PST | 12:00 PM EST

Excel Data Visualization - Charts and Infographics

In this session, participants will learn how to visually represent your data using both traditional charts (bar charts, line charts etc.) as well as how to do the same using some of Excel's non-charting tools.

Mike Thomas Mike Thomas | Duration: 60 Minutes | Price: $149.00 | View Details
  • 28
  • February
  • 2022
  • Monday
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.

Susanne Manz Susanne Manz | Duration: 3 Hours | Price: $299.00 | View Details
  • 28
  • February
  • 2022
  • Monday
10:00 AM PST | 01:00 PM EST

Project Management for Non-Project Managers - Determining, analyzing, and managing your project risk

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

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 2
  • March
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

Project Management for FDA-Regulated Companies

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

John E Lincoln John E Lincoln | Duration: 60 Minutes | Price: $149.00 | View Details
  • 2
  • March
  • 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 SOP’s to reduce the likelihood of human errors.

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 7
  • March
  • 2022
  • Monday
10:00 AM PST | 01:00 PM EST

Project Management for Non-Project Managers - Forming, developing, and managing your project team

The subject of this webinar is building the project team.

Charles H. Paul Charles H. Paul | Duration: 60 Minutes | Price: $149.00 | View Details
  • 14
  • March
  • 2022
  • Monday
10:00 AM PST | 01:00 PM EST

Project Management for Non-Project Managers - Managing your project resources and multiple projects - prevent burnout and over-utilization

This webinar will discuss all the resources that you need to employ to meet all your projects obligations and the techniques and the approaches to make that utilization effective.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 15
  • March
  • 2022
  • Tuesday
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
  • 21
  • March
  • 2022
  • Monday
10:00 AM PST | 01:00 PM EST

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

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

David Nettleton David Nettleton | Duration: 90 Minutes | Price: $149.00 | View Details
  • 22
  • March
  • 2022
  • Tuesday
10:00 AM PST | 01:00 PM EST

Project Management for Non-Project Managers - How to effectively monitor and control your project

This webinar will begin by discussing the eleven PM monitoring and controlling processes that are the foundation of the project management processes.

Charles H. Paul Charles H. Paul | Duration: 90 Minutes | Price: $149.00 | View Details
  • 30
  • March
  • 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: 90 Minutes | Price: $149.00 | View Details
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