21 CFR Part 820 Subpart 0 – Statistical Techniques
Description: By the end of this course you will have learned, how each manufacturer...
Course Code: ELM-315
by: Don Rackham
Macro-learning
21 CFR Part 820 Subpart N – Servicing
Description: As servicing is not required of all medical devices, this subpart of the...
Course Code: ELM-314
by: Don Rackham
Macro-learning
21 CFR Part 820 Subpart M – Records
Description: Records are what we create to provide the evidence that we are following...
Course Code: ELM-313
by: Don Rackham
Macro-learning
21 CFR Part 820 Subpart L – Handling, Storage, Distribution & Installation
Description: Just because we designed the product correctly, and made the product correctly, doesn’t...
Course Code: ELM-312
by: Don Rackham
Macro-learning
21 CFR Part 820 Subpart K – Labeling and Packaging Control
Description: Labeling may seem like a relatively simple topic, bit it is a very...
Course Code: ELM-311
by: Don Rackham
Macro-learning
21 CFR Part 820 Subpart J – Corrective and Preventive Action
Description: The Corrective and preventative actions, or CAPA, system is arguably the most important...
Course Code: ELM-310
by: Don Rackham
Macro-learning
ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part B)
Description: On occasion there will be product that is nonconforming to the required product...
Course Code: ELM-808
by: Don Rackham
Macro-learning
ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part A)
Description: As one of the measurements of the effectiveness of the quality management system...
Course Code: ELM-807
by: Don Rackham
Macro-learning
ISO 13485:2016 – Product Realization (Chapter 7 – Part B)
Description: The primary part of the purchasing requirements for ISO 13485 is to ensure...
Course Code: ELM-806
by: Don Rackham
Macro-learning
ISO 13485:2016 – Chapter 4: The Quality Management System (QMS)
Description: The learning objectives for this course are to understand what ISO 13485 is,...
Course Code: ELM-802
by: Don Rackham
Macro-learning