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:
Introduction
Course Introduction 58 secs
Course Overview 1 min 58 secs
Course Objectives 1 min 45 secs
Module 1 | The Starting Line
Terms Explained 1 min 51 secs
Benefits of Equipment Qualification 1 min 43 secs
US Regulatory Compliance 1 min 24 secs
European Regulations 1 min 53 secs
ICH Q9 1 min 25 secs
Module 2 | Equipment Qualification Planning
Equipment 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 Activities 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 | Risk Tools
User Requirement Specification (URS) 1 min 01 secs
Risk Assessment 1 min 13 secs
What is Risk? 1 min 33 secs
What is Risk Management? 1 min 06 secs
Risk Management Tools 1 min 19 secs
Risk Management Tools Cont'd 1 min 27 secs
HACCP – Hazard Analysis and Critical Control Points 1 min 55 secs
HAZOP – Hazard Operability Analysis 1 min 03 secs
FTA – Fault Tree Analysis 1 min 25 secs
PHA – Preliminary Hazard Analysis 1 min 28 secs
Quality Risk Management Tool Selection 1 min 32 secs
Failure Mode Effect Analysis (FMEA) 1 min 08 secs
So What is Expected During Regulatory Inspections? 1 min 01 secs
Step 1: Risk Detection/Identification 1 min 11 secs
Step 2 is Risk Analysis 1 min 14 secs
Step 3 is Risk Evaluation 1 min 19 secs
Risk Evaluation Methods – Quantitative Method 58 secs
Risk Evaluation Methods – Qualitative Method 1 min 28 secs
The Hybrid Method 1 min 11 secs
Severity & Probability 1 min 08 secs
Risk Control 50 secs
Risk Assessment Table 1 min 17 secs
Risk Communication 1 min 21 secs
Risk Review 1 min 28 secs
Module 4 | Qualification Phases
FAT (Factory Acceptance Testing) 1 min 17 secs
SAT (Site Acceptance Testing) 1 min 10 secs
Equipment Design Qualification (DQ) 1 min 18 secs
DQ Review Documents 1 min 22 secs
Installation Qualification (IQ) 1 min 33 secs
Documents to Analyze During IQ Review 1 min 09 secs
Pre-conditions for IQ Execution 1 min 27 secs
Equipment Operational Qualification (OQ) 1 min 14 secs
OQ and Commissioning 1 min 38 secs
Pre-Conditions for OQ Execution: 1 min 42 secs
Equipment Performance Qualification (PQ) 1 min 50 secs
Pre-conditions for PQ execution: 1 min 36 secs
Requalification 1 min 09 secs
Change Control 1 min 33 secs
Conclusion
Final Exam
Certification
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