CV In development

Cleaning Validation and Cross-Contamination Essentials

A medicine that helps one patient is a contaminant in the next patient's tablet. Every cleaning limit on a shared site is a promise about that second patient, and too many rest on a number nobody can now explain.

A short, complete course on cleaning validation and cross-contamination control as EudraLex Volume 4 expects them to work: judging the risk in a shared facility, setting limits from toxicology, designing a study around the real worst case, running it honestly, and keeping it validated as products, people and equipment change.

Duration: 2 to 3 hours, self-paced
Level: Practitioner
Lessons: 5 lessons

Join the waitlist

This course is in development

Cleaning Validation and Cross-Contamination Essentials is not open for enrolment yet. Join the waitlist and we will email you when it opens. Waitlist members receive the launch price, an early look at the curriculum and a chance to tell us which situations from their own site the course should cover.

Notify me when it opens

What the course teaches and assesses

Judge the risk: Name the routes of cross-contamination, apply the three tests for dedicated facilities, and use the HBEL through quality risk management to decide the controls.
Set limits from toxicology: Read a PDE assessment critically, turn it into acceptance limits set below the HBEL, and use visual inspection and older limits only as the EU texts allow.
Design the study: Choose and justify the worst case, cover the hold times and campaign lengths the procedure allows, and sample where recovery has been shown.
Run it honestly: Run the protocol the way routine cleaning is done, handle a failed run without cleaning again until it passes, and tell verification from validation.
Keep it validated: Trend routine results against alert limits, assess each new product before it enters the suite, and confirm manual cleaning at a justified frequency.

Lessons

1Why cross-contamination matters
2Setting limits
3Designing the study
4Running and evaluating
5Staying validated
Scored final exam and dated certificate

What this course does and does not do

Covered

Judge the risk
Design the study
Keep it validated

Not covered

Setting a PDE for a specific product, which needs a qualified toxicologist
Writing or approving your cleaning validation protocols
Analytical method validation for residue testing

This course is professional training. It does not replace your site’s procedures, and it is not regulatory or legal advice on a specific event.

Who it is for

Validation, QA, production and engineering
Anyone deciding if a product can enter a shared facility

For managers

Rolling cleaning validation and cross-contamination essentials out to a team?

The Site Readiness Programme adds a team heatmap from the self-assessment, a live session on the weakest questions, and records named by employee ID. Quote within two working days.

Seats for the whole team, priced per learner from 5 learners
Anonymised team heatmap: which questions your people fail, by chapter
90-minute live session built on the team's weakest questions

See the programme

Regulations referenced

EudraLex Volume 4, Chapter 1, 1.4(xii) to (xiv)
Chapter 3, Principle, 3.6 and 3.36
Chapter 5, 5.18 to 5.22
Annex 15, 9.1 and section 10
EMA HBEL guideline (EMA/CHMP/CVMP/SWP/169430/2012)
EMA Q&A on its implementation (EMA/CHMP/CVMP/SWP/246844/2018)
ICH Q9(R1)

Expected price at launch

€179

excl. VAT. Waitlist members hear first.

Cleaning Validation and Cross-Contamination Essentials, 5 lessons, knowledge checks, 12 months access · €179
Worked examples and knowledge checksEvery lesson runs on a real situation, with checks that ask you to make the call rather than recall a definition.
Template packThe report, assessment and investigation templates from the free resources, annotated with what a reviewer looks for in each field.
Before-and-after readiness scoreRetake the self-assessment after the course. Keep both scores as evidence of the gap you closed.
12 months of access, with author Q&AIncluding any updates made during that period. Ask the course author about your own deviations, changes and records.
Dated certificateNames the learner, the course and the exam result, with a unique ID any employer or auditor can check. Supports the training records EudraLex Volume 4 Chapter 2 expects you to keep.

Still under 75% on the retake? Tell us.

Finish the course and retake the chapter assessment. If you still score under 75%, email us with the questions you missed. We will point you at the material that covers them, and if it is quicker to talk it through, we will arrange a call.

Training a team? See the Site Readiness Programme

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