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Validity : 30th Nov'23 to 10th Dec'23
Search Trainings
Live Webinar
CGMP Manufacturing Methods - PPC and SPC
This webinar will define what are the US FDA's expectations for the use of statistical techniques, e.g., 21 CFr 820.25, for establishing, controlling, and verifying the acceptability of process capability and product characteristics, sampling plan justificatio ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
- Dec 05, 2023
Live Webinar
FDA - ICH Guideline Q9 R1 on Quality Risk Management
The training session aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application ...
- Basic & Advanced
- 90 Mins
- Meredith Crabtr
- Dec 05, 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
- Dec 07, 2023
Live Webinar
Using Excel Vlookup, Hlookup, Xlookup, Match, and Index
In Excel, sometimes there is a need to look up information from a table or from a different sheet, or to link the sheets together.
- Basic & Intermediate
- 60 Mins
- Tom Fragale
- Dec 07, 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
- Dec 07, 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
- Dec 11, 2023
Live Webinar
EUs New Regulation 535-2014 on Clinical Trials
linical trials are research studies in which people volunteer to help find answers to specific health questions. When carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health. Clinical trials are conducted acc ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
- Dec 15, 2023
Live Webinar
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. Procedures for controlling electronic signatures and electronic records as described in ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
- Dec 20, 2023
Live Webinar
US FDA Formally Proposes Aligning Quality System Regulations with ISO 13485
The United States Food and Drug Administration (FDA) plays a crucial role in regulating medical devices to ensure their safety and effectiveness. In an effort to harmonize its regulatory framework with international standards, the FDA has proposed aligning its ...
- Basic & Advanced
- 90 Mins
- Meredith Crabtr
- Dec 20, 2023
Live Webinar
Risk-based Design Control - The New Paradigm for Medical Device Design
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. Design control is not only a requirement of t ...
- Intermediate
- 60 Mins
- José Mora
- Jan 10, 2024