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Human Factors / Usability Studies following ISO 62366 the FDA Guidance and the new FDA Draft Guidance
Human Factors/ Usability is the analysis of how users 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 eff ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Feb 13, 2023
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
- Feb 16, 2023
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test ...
- Basic & Intermediate
- 90 Mins
- José Mora
- Feb 23, 2023
Cloud and Software-as-a-Service (SaaS) Vendors: Approach to Validation for FDA-Regulated System
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. Th ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Feb 24, 2023
Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud-hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulat ...
- Basic & Intermediate
- 90 Mins
- David Nettleton
- Feb 24, 2023
Medical Device Trends in FDA Compliance and Enforcement
This webinar will focus on medical devices, a key concern for FDA as they become more and more complex, and require methodical risk assessment and mitigation. Protecting medical devices from hacking where someone can alter the actual code embedded in the devic ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Mar 01, 2023
Medical Device Software Validation Meeting FDA Regulations
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Mar 09, 2023
How to Detect a Lack of Data Integrity
Data integrity is the assurance that data records are accurate, complete, intact, and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hy ...
- Basic & Intermediate
- 60 Mins
- Danielle Delucy
- Mar 09, 2023
Design Traceability Matrix - Principles of Lean Documents and Lean Configuration
Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design ...
- Basic & Intermediate
- 90 Mins
- José Mora
- Mar 15, 2023
Writing Effective SOPs for QMS in the Pharmaceutical and Medical Device Industries
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System.Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed.More importantly,well writt ...
- Basic & Intermediate
- 60 Mins
- Carl Patterson
- Mar 16, 2023