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Human Factors / Usability Studies following ISO 62366 the FDA Guidance and the new FDA Draft Guidance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
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
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
Best Practices in Preparation for an FDA Audit of Regulated Computer Systems
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer sys ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Mar 20, 2023
Best Practices in Preparation for an FDA Audit of Regulated Computer Systems
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer sys ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Mar 20, 2023
Vendor Audit for Systems and Services for FDA-Regulated Systems
This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by the FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Apr 07, 2023