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Usability Engineering Under IEC 62366
ANSI/AAMI/IEC 62366 is a Recognized Consensus Standard by the US FDA and a harmonized standard in the EU. This means that compliance with it provides a presumption of conformity to the requirements within those jurisdictions. Compliance with the standard help ...
- Basic & Intermediate
- 60 Mins
- Donald (Don) Hu
- Oct 03, 2022
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...
- Intermediate
- 90 Mins
- Ginette Collazo
- Oct 05, 2022
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 07, 2022
Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project review Meetings
This webinar is about effective communication inside and outside of the project team. The webinar will use case studies and examples to reinforce key teaching points. Instruction will begin with a discussion of the communication model and the barriers that ca ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
- Oct 11, 2022
Outsourcing Software Development for Medical Devices
This webinar will discuss the skillsets to look for when outsourcing, how to know if the work is compliant (without having to be an expert in software development), how to manage outsourced development, and your responsibilities throughout the product lifecycl ...
- Basic & Intermediate
- 60 Mins
- Donald (Don) Hu
- Oct 24, 2022
Project Management for Non-Project Managers - Determining,analyzing,and managing your project risk
This training will work through the risk analysis process from risk identification, risk mitigation, risk communication, and risk management by working through each step of a real-world project risk example.
- Basic & Intermediate
- 90 Mins
- Charles H. Paul
- Oct 24, 2022
21 CFR Part 11 Electronic Records/Signatures
The Webinar will focus on the importance of ensuring that the electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes developing a company philosophy and approach ...
- Intermediate
- 90 Mins
- Carolyn Troiano
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
Test Method Validation to Verify your Device Performance
This webinar will help you have an understanding of Test Method Validations to verify the performance of a Medical Device, global reference standards, the FDA requirements, and how to perform successful TMV to ensure your inspection of verification is effectiv ...
- Basic & Intermediate
- 60 Mins
- José Mora
Project Management for Non-Project managers
Today more than ever before the job titles that we hold are not entirely reflective of the work that we do. Global teams and collaboration often place those in positions of team leadership that have the least foundation to manage all facets of complex project ...
- Basic
- 90 Mins
- Charles H. Paul