CAPA – The Most Important Aspect of the QMS – Sec 820.100 [Video]
The Corrective and preventative actions, or CAPA, system is arguably the most important subsystem...
Course Code: ELM-310
by: Don Rackham
Micro-learning
How to Perform a Risk Assessment of Your Suppliers – Sec 820.50 (a)(1) [Video]
Once the supplier information is gathered a risk assessment of the supplier should be...
Course Code: ELM-305
by: Don Rackham
Micro-learning
Purchasing Controls for Medical Device Companies (21 CFR Part 820.50) [Video]
The first part of the purchasing control regulations appears fairly innocuous. There must be...
Course Code: ELM-305
by: Don Rackham
Micro-learning
Your 1 Minute Guide to the NCR Process [Video]
The NCR process is typically done in stages, with the first stage identifying the...
Course Code: ELM-309
by: Don Rackham
Micro-learning
6 Key Elements Your Record Management System Needs [Video]
A record is simply a completed document that provides empirical evidence that a process...
Course Code: ELM-802
by: Don Rackham
Micro-learning
Do You Know the Various Time Points for Stability Studies? [Video]
Stability studies are typically conducted for products which degrade, or may degrade, but they...
Course Code: ELM-311
by: Don Rackham
Micro-learning
The Two Different Approaches to Internal Quality Audits
Typically, when we think of quality audits, we’re thinking about internal quality audits which...
Course Code: ELM-302
by: Don Rackham
Micro-learning
ISO 13485:2016 – Keep the Quality Agreement Separate to the Supplier Agreement [Video]
It is recommended to keep the Quality Agreement separate from the Supply Agreement and...
Course Code: ELM-806
by: Don Rackham
Micro-learning
Medical Device Reporting Timelines for the US
Specific Timelines Medical device reporting timelines are very specific depending on the organization’s relationship...
Course Code: ELM-807
by: Don Rackham
Micro-learning
The Importance of Allowing Adequate Time for Design and Development Inputs | ISO 13485
Adequate time should be given to develop comprehensive design input requirements. Key Elements of...
Course Code: ELM-805
by: Don Rackham
Micro-learning