How to Perform a Failure Mode Effect Analysis (FMEA) – Part 1
Description: Quality Risk Management (QRM) principles require the evaluation of risk to patient safety...
Course Code: ELM-128
by: Joginder Mittal
Macro-learning
An Introduction to Process Validation – Part 2
Description: In the second part of our program on process validation, you will learn...
Course Code: ELM-402
by: Ginny Ojingwa
Macro-learning
An Introduction to Process Validation – Part 1
Description: In this course you will learn about general terms used in process validation....
Course Code: ELM-401
by: Ginny Ojingwa
Macro-learning
Why Process Validation is Reliant on a Detailed Design Review of the Product [Video]
Process validation is reliant upon a detailed review of the design of the product....
Course Code: ELM-401
by: Ginny Ojingwa
Micro-learning
10 Things You Need to Know About Creating User Requirements
1. Get SMART Requirements should be specific and appropriate for the desired system. Remember...
Course Code: ELM-127
by: Graham O'Keeffe
Micro-learning
Critical Process Parameters – Process Validation
The first phase of the process design entails developing a detailed knowledge and understanding...
Course Code: ELM-402
by: Ginny Ojingwa
Micro-learning
The 6 Fundamentals of a Solid User Requirement Specification (URS) [Video]
It’s important to use the standard approved URS template to document the requirements for...
Course Code: ELM-127
by: Graham O'Keeffe
Micro-learning
The Difference Between the Waterfall and Agile Approach to Software Development [Video]
The software life cycle should align with the company’s QMS and should be maintained...
Course Code: ELM-133
by: Kevin Martin
Micro-learning
8 Essential CSV Documents You Need for FDA Auditors [Video]
Testing is done, the software is released. What could go wrong? Audits and auditors!...
Course Code: ELM-119
by: Don Hurd
Micro-learning
The Relationship Between Equipment FATs and SATs [Video]
A process for validating equipment must also be established. Prior to validation it is...
Course Code: ELM-121
by: Don Rackham
Micro-learning
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