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Validity : 17th Sep'23 to 27th Sep'23
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Live Webinar
The Transfer of Validated Methods
This webinar will discuss the best practices for 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.
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Sep 22, 2023
Live Webinar
The 6 Most Common Problems in FDA Software Validation and Verification
This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
- Basic & Intermediate
- 120 Mins
- David Nettleton
- Sep 26, 2023
Live Webinar
Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through Personnel Training (Aseptic Practices, Cleanroom Behavior, and Contamination Control Procedures), Gowning Controls, Personnel Training, Cleanroom Traf ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
- Sep 26, 2023
Live Webinar
Medical Device Cybersecurity and FDA Compliance
This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could res ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Sep 27, 2023
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
Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance
This interactive webinar explains how to configure and validate GxP-compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ho ...
- Basic & Intermediate
- 75 Mins
- David Nettleton
- Oct 05, 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
How To Conduct Annual Product Reviews To Achieve GMP Compliance
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements in per US and Europe. Annual Product Quality Review ...
- Intermediate
- 60 Mins
- Danielle Delucy
- Oct 06, 2023