An Introduction to Cleaning Validation

Description:

This course has been created for anyone who is interested in learning more about cleaning validation within a regulated environment. If you would like to expand your knowledge of cleaning validation, but find it difficult to get involved on cleaning validation projects, this course is the perfect starting point.

Curriculum for this course:
Introduction
Overview 1 min 50 secs
Learning objectives 1 min 41 secs
Who should take this course? 1 min 30 secs
Course modules 1 min 09 secs
Module 1: The Starting Line
The predicate rules and best practices 1 min 55 secs
Why clean? 1 min 22 secs
Potential contaminants 2 min 22 secs
What is cleaning validation? 1 min 18 secs
Why perform cleaning validation? 1 min 41 secs
Module 2: Rules and Guidelines
Regulatory requirements 1 min 23 secs
Cleaning validation regulatory requirements 1 min 33 secs
Cleaning validation guidelines 1 min 41 secs
Module 3: The Cleaning Validation Process
The scope of cleaning validation 1 min 58 secs
The cleaning validation sequence 1 min 30 secs
Pre-requisites 1 min 20 secs
Cleaning validation strategy, plan and policy 1 min 40 secs
Campaign production and batch production 1 min 19 secs
Minor and major equipment 1 min 51 secs
Dedicated equipment 1 min 37 secs
Grouped products 1 min 17 secs
Grouped equipment 1 mins 10 secs
Worst case 2 mins 09 secs
Sampling 1 min 18 secs
Analytical methods 1 min 37 secs
Revalidation 2 mins 10 secs
Sampling 1 min 37 secs
Swab sampling 1 min 20 secs
Rinse sampling 1 min 50 secs
Visual examination 1 min 11 secs
Placebo testing 1 min 33 secs
Direct surface monitoring 1 min 45 secs
Recovery studies 1 min 30 secs
Recovery factor 1 min 51 secs
Analytical method selection and development 1 min 33 secs
Analytical method validation 2 min 20 secs
Acceptance criteria 1 min 39 secs
Acceptance limits 1 min 41 secs
Not set by regulatory agencies 1 min 58 secs
Industry limits 1 min 07 secs
Calculations 1 min 14 secs
Based on therapeutic dose 1 min 49 secs
Based on toxicity 1 min 25 secs
Based on analytical detectability 1 min 29 secs
Based on process capability 1 min 48 secs
Microbial acceptance limits 1 min 29 secs
Cleaning method development 1 min 22 secs
Critical sites 1 min 15 secs
Master validation plan 1 min 08 secs
Cleaning validation plan 1 min 29 secs
Cleaning process SOP 1 min 18 secs
Cleaning validation protocols 45 secs
Term sheets 58 secs
Protocol execution 1 min 36 secs
Deviations 1 min 46 secs
Clean and dirty hold times 1 min 26 secs
Dirty hold times 1 min 41 secs
Clean hold times 1 min 09 secs
Validation report 1 min 50 secs
Post validation monitoring 2 min 21 secs
Maintaining the validated state 1 min 30 secs
Retrospective cleaning validation 1 min 18 secs
When is retrospective validation permitted? 1 min 10 secs
Retrospective cleaning validation flow diagram 1 min 44 secs
Conclusion
Final Exam
Certification
Author:

Start Learning Today!

We’ve got pricing plans to suit everyone

View Our Pricing Plans