The 7 Process Chapters of the MDSAP Audit Roadmap
Now, let’s consider the MDSAP Audit Roadmap process.  The Auditor will follow each of...
Course Code: ELM-135
by: Ginny Ojingwa
Micro-learning
What is the Medical Device Single Audit Program (MDSAP) [Video]
The Medical Device Single Audit Program (MDSAP) was developed by the FDA and international...
Course Code: ELM-135
by: Ginny Ojingwa
Micro-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
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 3 Phases of Process Validation to Ensure Quality, Safety & Efficacy [Video]
According to the FDA’s new guidance on process validation which was published in 2011....
Course Code: ELM-402
by: Ginny Ojingwa
Micro-learning
Traditional Vs Modern Approach to Process Validation [Video]
Prior to 2011, Process Validation (PV) was defined as Documented evidence that the process,...
Course Code: ELM-402
by: Ginny Ojingwa
Micro-learning
How to Decide What Processes Need to be Validated [Video]
Each process should have specifications describing both the process parameters and the desired product....
Course Code: ELM-401
by: Ginny Ojingwa
Micro-learning
6 Key Areas for the FDA Audit for Process Validation [Video]
In general, validation is confirmation by examination and provision of objective evidence that the...
Course Code: ELM-401
by: Ginny Ojingwa
Micro-learning
Typical Contents of a Validation Master Plan (VMP)
A Validation Master Plan, also referred to as “VMP”, outlines the principles involved in...
by: Ginny Ojingwa
Micro-learning