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Live Webinar
How to Write and Manage a Change Control System
This webinar will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination o ...
- Basic & Intermediate
- 60 Mins
- Danielle Delucy
- Sep 29, 2023
Live Webinar
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. All methods must be validated, the proof t ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Oct 02, 2023
Live Webinar
Design, develop, and Implement an Effective Line Clearance Program
Within the Pharmaceutical Industry, the changeover from one product to another on a filling/packaging line, although relatively a simple concept, has significant implications from a regulatory standpoint if cross-contamination is permitted to occur. Preventin ...
- Basic & Intermediate
- 90 Mins
- Charles H. Paul
- Oct 03, 2023
Live Webinar
Computer System Validation (CSV) for FDA-Regulated Computers
As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting regulatory compliance requi ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Oct 05, 2023
Live Webinar
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis widely used to determine purity, impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Oct 16, 2023
Live Webinar
The Secrets of Outlook 365 Revealed Demonstrated in Outlook 365
In this webinar, you will learn to use little-known Outlook features and advanced features that are hiding in plain sight. Not only will you learn about the features, but you’ll learn the benefits of those features from a time management viewpoint. Effective ...
- Basic & Intermediate
- 60 Mins
- Karla Brandau
- Oct 18, 2023
Live Webinar
Managing the People Aspect of Change
Organizations often use internal or external change management experts to help the organization create effective change management programs and plans. However, these change management experts often engage with key stakeholders without a plan to provide change ...
- Basic & Intermediate
- 60 Mins
- Suzanne Blake,
- Oct 20, 2023
Live Webinar
Deviation Write-Ups and Management
Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some sever ...
- Intermediate
- 60 Mins
- Danielle Delucy
- Oct 23, 2023
Live Webinar
How to Deal with Bad Results Under GLP
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.
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Oct 31, 2023
Live Webinar
Vendor Audit for Systems and Services for FDA-Regulated Systems
This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, requ ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Oct 31, 2023