11:24

What is FMEA? l Failure Mode Effects Analysis Explained l The Learning Reservoir

08:24

8 Tips on How to Build a Strong Audit Team l Internal Auditing l The Learning Reservoir

05:52

How to Conduct a Successful ISO 13485:2016 Internal Audit Closing Meeting l The Learning Reservoir

02:24

MDSAP Audit Assessment Cycle l Medical Device Single Audit Program l The Learning Reservoir

06:05

What is MDSAP l Medical Device Single Audit Program l The Learning Reservoir

06:07

HACCP Prerequisite program l The Learning Reservoir

09:08

What is ISO 14001? l Environmental Management Systems l The Learning Reservoir

06:07

What is ISO 19011:2018? l Auditing Management Systems l The Learning Reservoir

06:45

What is 21 CFR 820 l Quality System Regulation l The Learning Reservoir

08:12

HACCP Critical Control Point l CCP l The Learning Reservoir

12:01

What is ISO 22000:2018? l The Learning Reservoir

06:58

What is the EU MDR ? l The Learning Reservoir

02:02

ISO 13485 Post-Market Surveillance l The Learning Reservoir

03:19

ISO 13485 Authorized Representative l The Learning Reservoir

01:53

ISO 13485 Advisory Notice l The Learning Reservoir

07:47

ISO 13485 "Process Approach" to a Quality Management System l The Learning Reservoir

04:46

Device History Record vs. Device Master Record l 21 CFR 820 DHR DMR l The Learning Reservoir

07:31

Medical Device Process Validation l QSR and Process Validation l The Learning Reservoir

07:01

CAPA KPIs for Medical Devices l The Learning Reservoir

08:31

What are FDA Pharma CGMPs l What are Drug CGMPs? l The Learning Reservoir

06:03

What are Food Safety Hazards? l HACCP Food Safety Hazards l The Learning Reservoir

02:09

FDA cGMP Final Guidance for Combination Products l 21 CFR Part 4 Guidance l The Learning Reservoir

03:16

The FDA CGMP Requirements for Combination Products Explained l The Learning Reservoir

04:24

What is the Quality System Inspection Technique (QSIT) l FDA QSIT 21CFR 820 l The Learning Reservoir

04:37

What is a FDA 483 Observation? l FDA Form 483 l FDA Enforcement Action l The Learning Reservoir

03:35

Important HACCP Definitions l HACCP Terminology l The Learning Reservoir

07:04

What is HACCP? l Hazard Analysis and Critical Control Point l The Learning Reservoir

15:25

ISO 13485: 2016 Internal Audit Requirements l Medical Device Internal Audit l The Learning Reservoir

03:34

What is a Medical Device? l Definition of a Medical Device l The Learning Reservoir

03:41

What is a FDA Warning Letter? l Warning Letter l FDA Enforcement Action l The Learning Reservoir

02:08

What is a CAPA System? l Corrective and Preventive Action l The Learning Reservoir

02:01

8D Problem Solving Technique l 8D Methodology l 8D Process l The Learning Reservoir

05:07

What is a Problem Statement? l Problem Statement in Problem Solving l The Learning Reservoir

05:13

The Difference Between a Quality Culture and a Traditional Culture l The Learning Reservoir

03:57

FDA Waterfall Design Process for Medical Devices l The Learning Reservoir

02:11

Aseptic sampling l What is Sampling? l The Learning Reservoir

03:25

CAPA Correction vs. Corrective Action l Corrective and Preventive Action l The Learning Reservoir

03:12

The Mean Time Between Failures (MTBF) Explained

10:31

What is 5S? | 5S Organizational Method | The Learning Reservoir

03:55

What does "operations" mean in the manufacturing sector? l The Learning Reservoir

05:59

Introduction to ISO 13485:2016 l Medical Device Quality Management System l The Learning Reservoir

01:06

What is Total Quality Management?

07:58

Introduction to ISO 9001: 2015

01:39

Summary of a Corrective and Preventive Action (CAPA) Process l The Learning Reservoir

05:14

What is Statistical Process Control (SPC)?

08:17

The Reliability Bathtub Curve Explained

02:48

History of Measurement System (Metric System)

01:19

The Difference between Discrete and Continuous Variables

01:47

History of Control Charts

03:05

The role of Suppliers in a Just-in-Time (JIT) Manufacturing System

03:06

History of Six Sigma l The Learning Reservoir

04:43

Understanding Quality in the Manufacturing Process

02:29

How do you define the "Quality" of a product or service?

01:00

21 CFR 211 cGMP e-Learning course