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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
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
CAPA and Root Cause Analysis Using the 8D Problem-Solving Approach
Root Cause Analysis is a critical component of CAPA, aiming to identify the underlying causes or factors that contribute to problems or non-conformances. By analyzing these root causes, organizations can gain a comprehensive understanding of the issues they fa ...
- Basic & Advanced
- 90 Mins
- Charles H. Paul
- Sep 28, 2023
Live Webinar
Human Error and Management Systems: Designing Errors Out
If you work in the GMP regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
- Sep 28, 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
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
Data Integrity 21 CFR Part 11
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing d ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
- Oct 10, 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