Webinar Search Results : 24 Upcoming webinars found.
Carolyn Troiano Tuesday, April 30, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Carolyn Troiano
In-Depth Testing of Computer Systems Regulated by FDA
This webinar will cover all aspects of testing to ensure that a computer system regulated by FDA "does what it purports to do," as per the guidance on computer system validation (CSV) from FDA, first issued in 1983.

Michael Abitz Wednesday, May 1, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Michael Abitz
Fishbone Diagramming
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Michael Brodsky Thursday, May 2, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Michael Brodsky
ISO/IEC 17025:2017 Update Introduction: Everything Old is New Again
Many laboratories have successfully developed and implementied a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs.

Todd B. Graham Friday, May 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Todd B. Graham
Quality Control for Microbiological Media and Reagents
This webinar will help you develop a quality control program that fits your microbiological laboratory's needs. We will explicitly not cover any serological, immunological or molecular tests.

Angela Bazigos Friday, May 3, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
FDA's 21 CFR 11 Add-On Inspections - Recent Updates
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

Dr. Ludwig Huber Wednesday, May 8, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: $150.00
by: Dr. Ludwig Huber
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Michael Brodsky Wednesday, May 15, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Michael Brodsky
ISO/IEC 17025:2017 Section 4 - General Requirements, Section 5 - Structural Requirements and Section 6 - Resource Requirements
Many laboratories have successfully developed and implementing a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs.

Joy McElroy Thursday, May 16, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Joy McElroy
GLPs: How are they Associated with GMPs and SOPs
In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.

Michael Abitz Tuesday, May 21, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Michael Abitz
Root Cause Failure Analysis Closed Loop Corrective Action
Root Cause Failure Analysis is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

David Nettleton Tuesday, May 21, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: $150.00
by: David Nettleton
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.

Dr. Ludwig Huber Thursday, May 23, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: $150.00
by: Dr. Ludwig Huber
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. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

Angela Bazigos Friday, May 24, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
FDA's Quality Metrics - Latest Advances
This presentation has been created directly from FDA material, using slides from FDA presentations, both internally to the FDA and to the industry at large. Comments from FDA and industry experts have been captured as well, to provide context and deeper understanding for the trainee.

Susanne Picard Tuesday, May 28, 2019
08:00 AM PDT | 11:00 AM EDT
Duration:60 Minutes
Price: $150.00
by: Susanne Picard
Overcoming Obstacles of the Canadian Drug Regulatory Landscape
Learn what common obstacles are in the Canadian Drug Development and Approval Process and how to avoid them or manage them efficiently should they occur.

Angela Bazigos Friday, May 31, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Deciding When to Submit a 510(k) for a Change to an Existing Device
A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements is about to be significantly changed or modified in design, components, method of manufacture, or intended use.

Carolyn Troiano Friday, May 31, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Carolyn Troiano
3-Hour Virtual Seminar on Computer System Validation (CSV) for FDA-Regulated Computers
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.

Angela Bazigos Friday, June 7, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science".

Carolyn Troiano Monday, June 10, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Carolyn Troiano
21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
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.

Michael Brodsky Thursday, June 20, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Michael Brodsky
ISO/IEC 17025:2017 Section 7 - Process Requirements and Section 8 - Management System Requirements
Many laboratories have successfully developed and implemented a functional quality management system based on the requirements of ISO/IEC 17025:2005.

Gwendolyn Wise-Blackman Thursday, June 20, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: $150.00
by: Gwendolyn Wise-Blackman
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.Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.

Angela Bazigos Friday, June 21, 2019
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: $290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis.

Susanne Picard Tuesday, June 25, 2019
08:00 AM PDT | 11:00 AM EDT
Duration:60 Minutes
Price: $150.00
by: Susanne Picard
Demystifying the Canadian Drug and Health Products Regulatory Landscape
In this webinar, we will demystify broadly what the current Canadian regulatory landscape is for efficient Canadian development initiatives.

Angela Bazigos Wednesday, June 26, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Angela Bazigos
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
This live interactive presentation will also discuss the regulations associated with the detection, correction and prevention of human errors in GMP manufacturing and laboratory processes.

Carolyn Troiano Friday, June 28, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Carolyn Troiano
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 Friday, July 12, 2019
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: $150.00
by: Carolyn Troiano
Good Documentation Practices to Support FDA Computer System Validation
As a "GxP"system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.

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