Introduction to Risk Based Equipment Qualification

Description:

This course describes how to assess the risks to product quality in the event of a functional failure of equipment used in a pharmaceutical cGMP environment. The risk based qualification assessment describes the qualification steps (Risk Assessment, Design, Installation, Operational and Performance Qualification etc.) required to qualify the equipment in order mitigate that risk.

Curriculum for this course:
Course Introduction
Course Overview 1 min 58 secs
Course Objectives 1 min 45 secs
Module 1 | The Starting Line
Terms Explained 1 min 51 secs
Safety & Business 1 min 43 secs
US Regulatory Compliance 1 min 24 secs
European Regulations 1 min 53 secs
Benefits – ICH Q9 1 min 25 secs
Module 2 | Qualification Planning
Qualification Process 1 min 19 secs
Qualification Planning 1 min 47 secs
Master Validation Plans 1 min 14 secs
Qualification Need Assessment 1 min 25 secs
Risk Classification 1 min 21 secs
Direct Impact 1 min 20 secs
Indirect Impact 1 min 33 secs
No Impact 1 min 13 secs
Impact Based Qualification 1 min 17 secs
Direct Impact Documentation 1 min 24 secs
Indirect Impact Documentation 1 min 30 secs
Master Validation Plan Listing 1 min 59 secs
Module 3 | Qualification Phases
User Requirement Specification (URS) 1 min 47 secs
Risk Assessment 1 min 59 secs
What is Risk? 1 min 39 secs
What is Risk Management? 1 min 18 secs
Risk Management Tools 1 min 33 secs
Risk Management Tools Cont'd 1 min 05 secs
HACCP – Hazard Analysis and Critical Control Points 1 min 07 secs
HAZOP – Hazard Operability Analysis 1 min 22 secs
FTA – Fault Tree Analysis 1 min 37 secs
PHA – Preliminary Hazard Analysis 1 min 57 secs
Quality Risk Management Tool Selection 1 min 41 secs
QRM Tool Selection Matrix 1 min 28 secs
Failure Mode Effect Analysis (FMEA) 1 min 20 secs
So What is Expected During Regulatory Inspections? 1 min 09 secs
Step 1: Risk Detection/Identification 1 min 55 secs
Step 2: Risk Analysis 1 min 10 secs
Step 3: Risk Evaluation 1 min 30 secs
Risk Evaluation Methods – Quantitative Method 1 min 19 secs
Risk Evaluation Methods – Qualitative Method 1 min 52 secs
The Hybrid Method 1 min 55 secs
Severity & Probability 1 min 08 secs
Risk Control 1 min 56 secs
Risk Assessment Table 1 min 18 secs
Risk Communication 1 min 29 secs
Risk Review 1 min 26 secs
FAT (Factory Acceptance Testing) 1 min 30 secs
SAT (Site Acceptance Testing) 1 min 32 secs
Equipment Design Qualification (DQ) – With Template 1 min 57 secs
DQ Review Documents 1 min 58 secs
Installation Qualification (IQ) – With Template 1 min 33 secs
Documents to Analyse During IQ Review 1 min 29 secs
Pre-conditions for IQ Execution 1 min 27 secs
Equipment Operational Qualification (OQ) – With Template 1 min 11 secs
OQ and Commissioning 1 min 14 secs
Pre-Conditions for OQ Execution 1 min 44 secs
Equipment Performance Qualification (PQ) – With Template 1 min 31 secs
Pre-conditions for PQ execution 1 min 51 secs
Requalification 1 min 52 secs
Change Control 1 min 39 secs
Conclusion
Final Exam
Certification
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