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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
Successful Supplier Audits
Process of following the procedures and processes that are agreed on during a selection audit process. It identifies nonconformances in the manufacturing process, engineering change process, invoicing process, quality process, and also the supplier/shipment pr ...
- Basic & Advanced
- 60 Mins
- Danielle Delucy
- Dec 18, 2023
Live Webinar
Fair Debt Collection Practices Act (FDCPA)
The FDCPA is a federal act that provides consumers with information around debt collection. Third party debt collectors have to abide by the regulations
- Basic & Advanced
- 60 Mins
- Justin Muscolin
- 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
Data Integrity and Governance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes development of a company philosophy and approach, and incorporating it into an overall computer system v ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Dec 21, 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
Live Webinar
Optimizing Efficiency: A Comprehensive Guide to 5S Principles
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. One method to improve productivity and reduce ...
- Intermediate
- 90 Mins
- Ginette Collazo
- Jan 11, 2024
Live 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
- Jan 16, 2024
Live 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
- Jan 29, 2024
Live Webinar
Risk Management for Medical Devices per ISO 14971 2019
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. During all phases of a project, any new consi ...
- Intermediate
- 60 Mins
- José Mora
- Mar 12, 2024