CEU Credits: 0.1
Course Code: ELM-601
Duration: 60 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V2.0
Effective Date: 09/08/2022
Curriculum for this course
Overview
Learning objectives
Who should take this course?
Course modules
The predicate rules and best practices
Why clean?
Potential contaminants
What is cleaning validation?
Why perform cleaning validation?
Regulatory requirements
Cleaning validation regulatory requirements
Cleaning validation guidelines
The scope of cleaning validation
The cleaning validation sequence
Pre-requisites
Cleaning validation strategy, plan and policy
Campaign production and batch production
Minor and major equipment
Dedicated equipment
Grouped products
Grouped equipment
Worst case
Sampling
Analytical methods
Revalidation
Sampling
Swab sampling
Rinse sampling
Visual examination
Placebo testing
Direct surface monitoring
Recovery studies
Recovery factor
Analytical method selection and development
Analytical method validation
Acceptance criteria
Acceptance limits
Not set by regulatory agencies
Industry limits
Calculations
Based on therapeutic dose
Based on toxicity
Based on analytical detectability
Based on process capability
Microbial acceptance limits
Cleaning method development
Critical sites
Master validation plan
Cleaning validation plan
Cleaning process SOP
Cleaning validation protocols
Term sheets
Protocol execution
Deviations
Clean and dirty hold times
Dirty hold times
Clean hold times
Validation report
Post validation monitoring
Maintaining the validated state
Retrospective cleaning validation
When is retrospective validation permitted?
Retrospective cleaning validation flow diagram
Conclusion
Final Exam
Certification
Fixed exam functionality.
V2.0
