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On-Demand Webinar
Assertiveness Skills for Leaders, Managers and HR Professionals
Stop Feeling Silenced, Start Saying Yes (to Yourself)! Do you struggle to voice your ideas, feel constantly swamped, or like your priorities get sidelined? This energizing workshop is your key to unlocking assertive leadership. Learn how to speak clearly, set ...
- Basic & Intermediate
- 60 Mins
- Suzanne Blake,
Recorded Webinar
Basic Issues of Method Validation Compliance under Good Laboratory Practices
Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees the validity of results. If you work in pharmaceuticals, chemicals, petrochemicals, and environmental ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
Recorded Webinar
European Union Device Regulation (EU MDR)
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes". In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The ...
- Intermediate
- 60 Mins
- Edwin Waldbusse
On-Demand Webinar
ChatGPT for Excel
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel ...
- Basic
- 60 Mins
- Tom Fragale
Recorded Webinar
FDA Regulation of Artificial Intelligence - Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulatio ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
Recorded Webinar
Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the ef ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
Recorded Webinar
An Advanced Course on Lean Documents, Lean Configuration and Document Control
In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of ...
- Basic & Intermediate
- 90 Mins
- José Mora
Recorded 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
Recorded 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
Recorded Webinar
Unraveling Mistakes: A Comprehensive Course on Human Error Investigation
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Person ...
- Intermediate
- 90 Mins
- Ginette Collazo