• 8
  • April
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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
  • 8
  • April
  • 2021
  • Thursday
08:00 AM PDT | 11:00 AM EDT

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

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

Danielle DeLucy Danielle DeLucy | Duration: 4 Hours | Price: $445.00 | View Details
  • 8
  • April
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Zero-Injury Workplace Culture vs. Safety Culture

This webinar will focus on evolving from a zero-incident workplace culture within any organization to a more safety-oriented culture.

Deidre Tate Deidre Tate | Duration: 60 Minutes | Price: $149.00 | View Details
  • 8
  • April
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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
  • 9
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

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
  • 9
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.

Angela Bazigos Angela Bazigos | Duration: 90 Minutes | Price: $149.00 | View Details
  • 12
  • April
  • 2021
  • Monday
08:00 AM PDT | 11:00 AM EDT

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
  • 12
  • April
  • 2021
  • Monday
08:00 AM PDT | 11:00 AM EDT

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

Statistics is a useful decision making tool in the clinical research arena.

Elaine Eisenbeisz Elaine Eisenbeisz | Duration: 6 Hours | Price: $545.00 | View Details
  • 13
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products.

Robert J. Russell Robert J. Russell | Duration: 3 Hours | Price: $299.00 | View Details
  • 13
  • April
  • 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
  • 13
  • April
  • 2021
  • Tuesday
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
  • 13
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Best Practices for Deviation Investigations

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.

Danielle DeLucy Danielle DeLucy | Duration: 60 Minutes | Price: $149.00 | View Details
  • 13
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement.

Roger Cowan Roger Cowan | Duration: 60 Minutes | Price: $149.00 | View Details
  • 13
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Food Supplier Auditing Plan, Post-COVID

You deal with hundreds of suppliers. And you need to make sure each and every one of them meet regulations and quality standards. How can you keep your eye on that many suppliers?

Gina Reo Gina Reo | Duration: 60 Minutes | Price: $149.00 | View Details
  • 13
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11

Part 11 / Annex 11 Computer Systems Validation (CSV) is to be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance.

Angela Bazigos Angela Bazigos | Duration: 3 Hours | Price: $299.00 | View Details
  • 13
  • April
  • 2021
  • Tuesday
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
  • 14
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends

CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.

David R Dills David R Dills | Duration: 60 Minutes | Price: $149.00 | View Details
  • 14
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Understanding the USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Dr. Ludwig Huber Dr. Ludwig Huber | Duration: 75 Minutes | Price: $149.00 | View Details
  • 14
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

FDA Regulation of Artificial Intelligence/ Machine Learning

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

Edwin Waldbusser Edwin Waldbusser | Duration: 60 Minutes | Price: $149.00 | View Details
  • 14
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles on Lean Documents and Lean Configuration

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Jose Mora Jose Mora | Duration: 60 Minutes | Price: $149.00 | View Details
  • 14
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Understanding International Logistics- The Basics of Air and Ocean Shipping

Air freight, or air cargo allows the transport of goods quickly by air. Shipping cargo by air has always been a high cost-to-weight form of shipment, countered by the fact that it is the fastest way to transport goods internationally.

Martin K. Behr, III Martin K. Behr, III | Duration: 90 Minutes | Price: $149.00 | View Details
  • 14
  • April
  • 2021
  • Wednesday
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
  • 15
  • April
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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

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

Robert J. Russell Robert J. Russell | Duration: 90 Minutes | Price: $149.00 | View Details
  • 15
  • April
  • 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
  • 15
  • April
  • 2021
  • Thursday
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
  • 15
  • April
  • 2021
  • Tuesday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Statistics for Quality 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
  • 16
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

FDA Issues Final Rule on Symbols in Labeling

The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.

David R Dills David R Dills | Duration: 60 Minutes | Price: $149.00 | View Details
  • 16
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

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
  • 16
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.

Dr. Ludwig Huber Dr. Ludwig Huber | Duration: 2 Hours | Price: $199.00 | View Details
  • 16
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

2-Hour Virtual Seminar on Power Analysis for Sample Size Calculations

In this webinar attendees will learn the statistical power analysis and techniques for determining sample size (a priori techniques) calculation.

Elaine Eisenbeisz Elaine Eisenbeisz | Duration: 2 Hours | Price: $199.00 | View Details
  • 16
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

Surviving OSHA Audit in Six Easy Steps

Recently, OSHA issued over 40,000 citations for safety violations in the workplace. In one example, a HVAC company was fined over $1.2 million for recordkeeping violations.

Deidre Tate Deidre Tate | Duration: 90 Minutes | Price: $149.00 | View Details
  • 19
  • April
  • 2021
  • Monday
10:00 AM PDT | 01:00 PM EDT

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: 90 Minutes | Price: $149.00 | View Details
  • 19
  • April
  • 2021
  • Monday
10:00 AM PDT | 01:00 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
  • 19
  • April
  • 2021
  • Monday
10:00 AM PDT | 01:00 PM EDT

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

Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements

Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.

David R Dills David R Dills | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • April
  • 2021
  • Tuesday
09:00 AM PDT | 12:00 PM EDT

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

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
  • 20
  • April
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Equipment Validation, Tracking, Calibration and Preventive Maintenance

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.

Jeff Kasoff Jeff Kasoff | Duration: 60 Minutes | Price: $149.00 | View Details
  • 20
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

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. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Teri C. Soli Teri C. Soli | Duration: 90 Minutes | Price: $149.00 | View Details
  • 20
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Handling OOS Test Results and Completing Robust Investigations

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.

Danielle DeLucy Danielle DeLucy | Duration: 90 Minutes | Price: $149.00 | View Details
  • 20
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

Angela Bazigos Angela Bazigos | Duration: 90 Minutes | Price: $149.00 | View Details
  • 20
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Using Statistics to Determine Sample Size

We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.

Steven Wachs Steven Wachs | Duration: 60 Minutes | Price: $149.00 | View Details
  • 21
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Postmarketing Vigilance Reporting For Medical Device Manufacturers

Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 6) came into force on January 1, 2008.

David R Dills David R Dills | Duration: 60 Minutes | Price: $149.00 | View Details
  • 21
  • April
  • 2021
  • Wednesday
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
  • 21
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records

Jose Mora Jose Mora | Duration: 90 Minutes | Price: $149.00 | View Details
  • 21
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Analytical Method Validation

An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

Jerry Lanese Jerry Lanese | Duration: 90 Minutes | Price: $149.00 | View Details
  • 21
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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
  • 21
  • April
  • 2021
  • Wednesday
08:00 AM PDT | 11:00 AM EDT

4-Hour Virtual Seminar on Credit Risk Management- Principles and Practices, Tools and Techniques

Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives.

Dev Strischek Dev Strischek | Duration: 4 Hours | Price: $445.00 | View Details
  • 22
  • April
  • 2021
  • Thursday
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
  • 22
  • April
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Preparing for OSHA Voluntary Protection Program (VPP): Brick by Brick

The OSHA Voluntary Protection Program (VPP) is the highest award in Health and Safety Excellence that OSHA presents to an organization.

Deidre Tate Deidre Tate | Duration: 90 Minutes | Price: $149.00 | View Details
  • 22
  • April
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Foreign Trade Zones- Understanding and Making Good Use of Them

U.S. foreign-trade zones (FTZs) are geographic areas declared to be outside the normal customs territory of the United States.

Martin K. Behr, III Martin K. Behr, III | Duration: 90 Minutes | Price: $149.00 | View Details
  • 22
  • April
  • 2021
  • Thursday
08:00 AM PDT | 11:00 AM EDT

6-Hour Virtual Seminar on Adaptive Design for Clinical Trial

Clinical trials are expensive, time-consuming, and labor-intensive. And in the traditional sense, study designs are inflexible.

Elaine Eisenbeisz Elaine Eisenbeisz | Duration: 6 Hours | Price: $545.00 | View Details
  • 23
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

Conducting Successful Product Complaint Investigations

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

David R Dills David R Dills | Duration: 90 Minutes | Price: $149.00 | View Details
  • 23
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

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. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

Danielle DeLucy Danielle DeLucy | Duration: 60 Minutes | Price: $149.00 | View Details
  • 23
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

Validation of Analytical Methods and Procedures

Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

Dr. Ludwig Huber Dr. Ludwig Huber | Duration: 75 Minutes | Price: $149.00 | View Details
  • 23
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

Key Elements in Managing and Maintaining your Credit Administration and Credit Policy

This session by Dev Strischek is intended to provide guidance on how to develop and maintain a Credit Administration (CA) function that will provide guidance to anyone involved in the credit function of the bank.

Dev Strischek Dev Strischek | Duration: 60 Minutes | Price: $149.00 | View Details
  • 26
  • April
  • 2021
  • Monday
10:00 AM PDT | 01:00 PM EDT

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

Dennis Taylor Dennis Taylor | Duration: 2 Hours | Price: $199.00 | View Details
  • 26
  • April
  • 2021
  • Monday
10:00 AM PDT | 01:00 PM EDT

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
  • 26
  • April
  • 2021
  • Monday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on 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: 3 Hours | Price: $299.00 | View Details
  • 26
  • April
  • 2021
  • Monday
10:00 AM PDT | 01:00 PM EDT

Power Analysis for Sample Size Calculations

In this webinar attendees will learn the statistical power analysis and techniques for determining sample size (a priori techniques) calculation.

Elaine Eisenbeisz Elaine Eisenbeisz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 26
  • April
  • 2021
  • Monday
10:00 AM PDT | 01:00 PM EDT

Useful Statistical Methods for Defining Product and Process Specifications

Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.

Steven Wachs Steven Wachs | Duration: 90 Minutes | Price: $149.00 | View Details
  • 27
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Data Integrity and Privacy for FDA Regulated Industries

Effective and compliant data management is critical to organizations in the regulated industries. Data integrity is defined as the extent to which all data is complete, consistent, accurate, trustworthy, and reliable throughout the data lifecycle, from its creation to archiving and its eventual destruction.

Eleonora Babayants Eleonora Babayants | Duration: 90 Minutes | Price: $149.00 | View Details
  • 27
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Managing Corporate Culture During COVID-19

Your organization needs to understand how to maintain team cohesiveness with a remote workforce that is working from home.

Robert Greene and Marques Ogden Robert Greene and Marques Ogden | Duration: 60 Minutes | Price: $149.00 | View Details
  • 27
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Dietary Supplements CGMPS - 21 CFR 111 Compliance

21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 27
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner

A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.

Jeff Kasoff Jeff Kasoff | Duration: 60 Minutes | Price: $149.00 | View Details
  • 27
  • April
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems

Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.

Teri C. Soli Teri C. Soli | Duration: 90 Minutes | Price: $149.00 | View Details
  • 27
  • April
  • 2021
  • Tuesday
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
  • 27
  • April
  • 2021
  • Tuesday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on Bootcamp on How the FDA are Trained for Medical Device Inspections

This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms. It will present the specific guidance FDA inspectors receive for each of the regulations.

Angela Bazigos Angela Bazigos | Duration: 3 Hours | Price: $299.00 | View Details
  • 28
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on Complaint Handling and Management: From Receipt to Trending

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

David R Dills David R Dills | Duration: 3 Hours | Price: $299.00 | View Details
  • 28
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations.

Dr. Ludwig Huber Dr. Ludwig Huber | Duration: 75 Minutes | Price: $149.00 | View Details
  • 28
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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
  • 28
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect.

Jose Mora Jose Mora | Duration: 60 Minutes | Price: $149.00 | View Details
  • 28
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Laboratory Investigation of Out-of-Specification Results

The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

Jerry Lanese Jerry Lanese | Duration: 90 Minutes | Price: $149.00 | View Details
  • 28
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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
  • 28
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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: 90 Minutes | Price: $149.00 | View Details
  • 28
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Implementing Process Controls for Cell-Based Assays

Bioassays are used to demonstrate that a biologic product performs per the stated function and potency.

Gwendolyn Wise-Blackman Gwendolyn Wise-Blackman | Duration: 60 Minutes | Price: $149.00 | View Details
  • 28
  • April
  • 2021
  • Wednesday
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
  • 29 & 30
  • April
  • 2021
  • Thursday
08:00 AM PDT | 11:00 AM EDT

2-Day Virtual Seminar on Best Practices for Import & Export Control & Customs Compliance During & After COVID 19

FDA’s import and export programs are complex, detailed and undergo changes without notice to the public.

Casper Uldriks Casper Uldriks | Duration: 2 Days | Price: $995.00 | View Details
  • 29
  • April
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Preparing for an FDA Inspection - What you Need to Know

Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively.

Susanne Manz Susanne Manz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 29
  • April
  • 2021
  • Thursday
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
  • 30
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations

This webinar will review the regulatory requirements for investigating an OOS Investigation.

Danielle DeLucy Danielle DeLucy | Duration: 3 Hours | Price: $299.00 | View Details
  • 30
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products

What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?

David R Dills David R Dills | Duration: 90 Minutes | Price: $149.00 | View Details
  • 30
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA-EMA, USP and ICH

The 3-hour virtual seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement even most critical requirements.

Dr. Ludwig Huber Dr. Ludwig Huber | Duration: 3 Hours | Price: $299.00 | View Details
  • 30
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 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
  • 30
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems

Documentation is a critical tool for ensuring GxP/GMP compliance.

Eleonora Babayants Eleonora Babayants | Duration: 90 Minutes | Price: $149.00 | View Details
  • 30
  • April
  • 2021
  • Friday
12:00 PM PDT | 03:00 PM EDT

Complaint Handling in Compliance with FDA and ISO Regulations

Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.

Jeff Kasoff Jeff Kasoff | Duration: 60 Minutes | Price: $149.00 | View Details
  • 30
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

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
  • 30
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

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: 60 Minutes | Price: $149.00 | View Details
  • 30
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

Tips and Techniques for Handling Missing Data (Statistical Techniques)

If you work with data, you should attend this webinar. Real life data is not pretty. It is messy and often incomplete.

Elaine Eisenbeisz Elaine Eisenbeisz | Duration: 90 Minutes | Price: $149.00 | View Details
  • 30
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

The Credit Manager's Tool Box - Tools And Techniques For Making Sound Credit Decisions

This webinar will provide guidance on how gather information, evaluate it, and make sound credit decisions on prospective clients and existing borrowers You will also learn the differences between unaudited and audited financials and how to use and interpret financial ratios in your analysis.

Dev Strischek Dev Strischek | Duration: 60 Minutes | Price: $149.00 | View Details
  • 4
  • May
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Combating Racism in the Workplace

You need to eradicate racism in the workplace and promote unity. Learn how to build an inclusive and equitable organization, ensure fairness for all employees, candidates, customers, and other stakeholders.

Robert Greene and Marques Ogden Robert Greene and Marques Ogden | Duration: 60 Minutes | Price: $149.00 | View Details
  • 5
  • May
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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
  • 5
  • May
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

OSHA's Final Rule: Worker Exposure to Respirable Crystalline Silica

Exposure to silica has been linked to lung cancer, silicosis, chronic obstructive pulmonary disease, and kidney disease in workers.

Deidre Tate Deidre Tate | Duration: 90 Minutes | Price: $149.00 | View Details
  • 5
  • May
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Verification vs Validation-Product, Process or Equipment and QMS Software

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 5
  • May
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

The Income Statement - What a Banker Can Learn About a Borrower from Its Profit and Loss Statement

This topic will explore all aspects of an income statement and Loss Statement and how the information that a profit and loss statement contains about a borrower's operating performance can assist in making credit decisions.

Dev Strischek Dev Strischek | Duration: 60 Minutes | Price: $149.00 | View Details
  • 5
  • May
  • 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
  • 10
  • May
  • 2021
  • Monday
10:00 AM PDT | 01:00 PM EDT

Root Cause Analysis - Starting at the Beginning

CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

John E Lincoln John E Lincoln | Duration: 60 Minutes | Price: $149.00 | View Details
  • 10
  • May
  • 2021
  • Monday
10:00 AM PDT | 01:00 PM EDT

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

Implementing an Effective CAPA System

CAPA, no matter how you look at it, is the heart of the quality management system. CAPA can be viewed as and is the merging of change control, continuous improvement, and complaint management.

Charles H. Paul Charles H. Paul | Duration: 60 Minutes | Price: $149.00 | View Details
  • 11
  • May
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Validation of HPLC/UPLC Methodologies

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

John C. Fetzer John C. Fetzer | Duration: 60 Minutes | Price: $149.00 | View Details
  • 11
  • May
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Supervising a Human Error Free Environment: You can do a Lot More than you Think

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

Ginette Collazo Ginette Collazo | Duration: 90 Minutes | Price: $149.00 | View Details
  • 11
  • May
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Cash Flow Analysis Of Borrower's Repayment Ability

There is an old saying in credit analysis, "Borrowers pay back loans from cash flow, not profits." But it is not just cash flow; it is cash flow from operations that is the most desirable source of repayment because it is generated by a borrower managing its working capital assets and earning a sustainable profit.

Dev Strischek Dev Strischek | Duration: 60 Minutes | Price: $149.00 | View Details
  • 13
  • May
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Identifying Social Injustice and Racial Inequality in the Workplace

Outside stress on employees can impact work performance.

Robert Greene and Marques Ogden Robert Greene and Marques Ogden | Duration: 60 Minutes | Price: $149.00 | View Details
  • 18
  • May
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

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
  • 20
  • May
  • 2021
  • Thursday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on CAPA for Medical Devices

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

Susanne Manz Susanne Manz | Duration: 3 Hours | Price: $299.00 | View Details
  • 25
  • May
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

FDA Best Audit Behavior 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
  • 27
  • May
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Account Based Marketing & Nurturing

Once a customer has been acquired, an organization needs to maximize the lifetime value of the relationship. This course will explore the following topics:

Robert Greene Robert Greene | Duration: 60 Minutes | Price: $149.00 | View Details
  • 1
  • June
  • 2021
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

John E Lincoln John E Lincoln | Duration: 90 Minutes | Price: $149.00 | View Details
  • 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
  • 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
  • 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
  • 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
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