A1 In development

Contamination Control and Annex 1 Essentials

Annex 1 is not a list of rules for cleanrooms. It asks one question: can you show how every source of contamination is controlled, and how you know the controls work?

A short, complete course on sterile manufacturing as EudraLex Volume 4, Annex 1 expects it to work: building a contamination control strategy, designing premises and barriers, qualifying and guiding the people who work near open product, monitoring the environment and the aseptic process, and bringing it all together in the decision to certify a batch.

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

Join the waitlist

This course is in development

Contamination Control and Annex 1 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

Read your CCS as a whole: Check that it covers every element Annex 1 lists, puts design before procedures and monitoring, and stays alive through change control and management review.
Understand the premises: Know what each grade is for, how pressure, airflow and airlocks protect the critical zone, and how isolators and RABS differ.
Work safely near open product: Know what training and gowning qualification Annex 1 asks for, how to move near first air, and when to speak up and stay out.
Respond to monitoring results: Tell an alert level from an action limit, take an excursion through to its impact on product, and know what a media fill proves and what it does not.
Support the release decision: Know the routes to a sterile product, what QC and the QP review before certification, and how what is learned goes back into the CCS.

Lessons

1Annex 1 and the contamination control strategy
2Premises and cleanrooms
3People
4Monitoring
5Sterile processes and release
Scored final exam and dated certificate

What this course does and does not do

Covered

Read your CCS as a whole
Work safely near open product
Support the release decision

Not covered

Designing cleanroom, isolator or RABS systems
Aseptic technique and gowning practice on the floor
Expert-level sterile process validation

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

Sterile production operators and supervisors
QA, QC microbiology, engineering and validation
QPs new to sterile products

For managers

Rolling contamination control and annex 1 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, Annex 1
Chapter 1, 1.4(xiv) and (xv)
Annex 15
Annex 16
ICH Q9(R1), section 3
ICH Q10, 4.1

Expected price at launch

€179

excl. VAT. Waitlist members hear first.

Contamination Control and Annex 1 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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Curriculum in development · waitlist open

€179expected, excl. VATGet notified