• 8
  • June
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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
  • 9
  • June
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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
  • 9
  • June
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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
  • 9
  • June
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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
  • 9
  • June
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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
  • June
  • 2021
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

6-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: 6 Hours | Price: $545.00 | View Details
  • 14
  • June
  • 2021
  • Monday
08:00 AM PDT | 11:00 AM EDT

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
  • 15
  • June
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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
  • 15
  • June
  • 2021
  • Tuesday
09:00 AM PDT | 12:00 PM EDT

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
  • 16
  • June
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Water System Biofilm Control and Microbial Monitoring Myths

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.

Teri C. Soli Teri C. Soli | Duration: 90 Minutes | Price: $149.00 | View Details
  • 17
  • June
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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
  • 17
  • June
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

HPLC Analytical Method Development and Validation

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

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • June
  • 2021
  • Friday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on The "New NAFTA": The USMCA

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

Martin K. Behr, III Martin K. Behr, III | Duration: 3 Hours | Price: $299.00 | View Details
  • 21
  • June
  • 2021
  • Monday
08:00 AM PDT | 11:00 AM EDT

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
  • 22
  • June
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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
  • 22
  • June
  • 2021
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

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
  • 22
  • June
  • 2021
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

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
  • 22
  • June
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Cost of Quality from Theory to Implementation

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

Yuval Shapiro Yuval Shapiro | Duration: 60 Minutes | Price: $149.00 | View Details
  • 22
  • June
  • 2021
  • Tuesday
09:00 AM PDT | 12:00 PM EDT

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
  • 23
  • June
  • 2021
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

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
  • June
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on Harmonized Tariff Schedule Classification

In this webinar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule.

Martin K. Behr, III Martin K. Behr, III | Duration: 3 Hours | Price: $299.00 | View Details
  • 24
  • June
  • 2021
  • Thursday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on EU Regulatory Affairs Strategy During Development of Medicinal Products

The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan.

Adriaan Fruijtier Adriaan Fruijtier | Duration: 6 Hours | Price: $545.00 | View Details
  • 24
  • June
  • 2021
  • Thursday
08:00 AM PDT | 11:00 AM EDT

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
  • 24
  • June
  • 2021
  • Thursday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Combination Products

This seminar provides Professionals working in this area with:

Salma Michor Salma Michor | Duration: 6 Hours | Price: $545.00 | View Details
  • 24
  • June
  • 2021
  • Thursday
09:00 AM PDT | 12:00 PM EDT

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
  • 25
  • June
  • 2021
  • Friday
08:00 AM PDT | 11:00 AM EDT

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
  • 25
  • June
  • 2021
  • Friday
08:00 AM PDT | 11:00 AM EDT

6-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: 6 Hours | Price: $545.00 | View Details
  • 28
  • June
  • 2021
  • Monday
08:00 AM PDT | 11:00 AM EDT

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
  • 28
  • June
  • 2021
  • Monday
08:00 AM PDT | 11:00 AM EDT

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
  • 28
  • June
  • 2021
  • Monday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 6-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: 6 Hours | Price: $545.00 | View Details
  • 28
  • June
  • 2021
10:00 AM PDT | 01:00 PM EDT

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
  • 28
  • June
  • 2021
  • Monday
10:00 AM PDT | 01:00 PM EDT

If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

John C. Fetzer John C. Fetzer | Duration: 90 Minutes | Price: $149.00 | View Details
  • 29
  • June
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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
  • 29
  • June
  • 2021
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

6-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: 6 Hours | Price: $545.00 | View Details
  • 29
  • June
  • 2021
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

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. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data.

Tom Fragale Tom Fragale | Duration: 6 Hours | Price: $545.00 | View Details
  • 29
  • June
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Bulletproof CAPA Process: How To Do It Right?

Mr. Yuval Shapiro shall present the requirements for Corrective and Preventive actions as required by medical devices standards (ISO13485, etc.), and the common practice.

Yuval Shapiro Yuval Shapiro | Duration: 60 Minutes | Price: $149.00 | View Details
  • 29
  • June
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Say Goodbye to NAFTA: The USMCA is Now Here

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

Martin K. Behr, III Martin K. Behr, III | Duration: 90 Minutes | Price: $149.00 | View Details
  • 30
  • June
  • 2021
  • Wednesday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on Bioanalytical Method Validation

The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics.

Gwendolyn Wise-Blackman Gwendolyn Wise-Blackman | Duration: 3 Hours | Price: $299.00 | View Details
  • 30
  • June
  • 2021
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

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
  • 30
  • June
  • 2021
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

6-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: 6 Hours | Price: $545.00 | View Details
  • 30
  • June
  • 2021
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

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
  • 1
  • July
  • 2021
  • Thursday
08:00 AM PDT | 11:00 AM EDT

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
  • 2
  • July
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

Auditing Laboratories Conducting Assays Supporting Biologics

Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.

Gwendolyn Wise-Blackman Gwendolyn Wise-Blackman | Duration: 60 Minutes | Price: $149.00 | View Details
  • 5
  • July
  • 2021
  • Monday
10:00 AM PDT | 01:00 PM EDT

Importing and Exporting Covid-19 Products

The outbreak of coronavirus disease (COVID-19), first in the People's Republic of China (PRC or China), and now globally, including in the United States, is drawing attention to the ways in which the United States and other economies depend on critical manufacturing and global value chains that rely on production based in in the PRC and other countries. Congress is particularly concerned about these dependencies and has passed legislation to better understand and address them.

Martin K. Behr, III Martin K. Behr, III | Duration: 90 Minutes | Price: $149.00 | View Details
  • 7
  • July
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Validation Challenges for Bioassays

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

Gwendolyn Wise-Blackman Gwendolyn Wise-Blackman | Duration: 60 Minutes | Price: $149.00 | View Details
  • 7
  • July
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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
  • 7
  • July
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Preventing Human Error in the Life Sciences

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

Charles H. Paul Charles H. Paul | Duration: 60 Minutes | Price: $149.00 | View Details
  • 8
  • July
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Computer System Validation (CSV) for FDA-Regulated Computers

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

Carolyn Troiano Carolyn Troiano | Duration: 90 Minutes | Price: $149.00 | View Details
  • 13
  • July
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

INCOTERMS 2020 Made Easy - Decoding your Shipment

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

Martin K. Behr, III Martin K. Behr, III | Duration: 90 Minutes | Price: $149.00 | View Details
  • 15
  • July
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Human Error Reduction in GMP Related Environments

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

Ginette Collazo Ginette Collazo | Duration: 60 Minutes | Price: $149.00 | View Details
  • 16
  • July
  • 2021
  • Friday
08:00 AM PDT | 11:00 AM EDT

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

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
  • 20
  • July
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

FDA's New Import Program for 2020 and Impact of the COVID-19

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

Casper Uldriks Casper Uldriks | Duration: 60 Minutes | Price: $149.00 | View Details
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