3 Types of Combination Products You Should Know [Video]
There are three types of combination products: Single entity Co-packaged or kits Cross-labeled A...
Course Code: ELM-145
by: Ginny Ojingwa
Micro-learning
Prepare Your Internal Audit Team for MDSAP in 3 Key Areas [Video]
Prepare the audit team for a Process-Based Audit and the MDSAP Audit Sequence. Internal...
Course Code: ELM-136
by: Ginny Ojingwa
Micro-learning
How the FDA Defines a Combination Product [Video]
21 CFR 3.2(e) defines a Combination Product as one comprised of any combination of...
Course Code: ELM-145
by: Ginny Ojingwa
Micro-learning
Want to Know the Mapped Regulatory Requirements of MDSAP?
The MDSAP has mapped within the audit program as follows: Medical device QMS requirements...
Course Code: ELM-135
by: Ginny Ojingwa
Micro-learning
Sterile Medical Device Requirements – Ensure Sterility is Preserved! [Video]
A new FDA section addressing sterile medical devices will require additional measures for the...
Course Code: ELM-136
by: Ginny Ojingwa
Micro-learning
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