Introduction to Cleaning in Pharma

Introduction to Cleaning in Pharma provides a basic understanding of the various concepts within cleaning processes and how adequate cleaning of equipment/facilities is documented. Cleaning is an important part of ensuring product quality and patient safety. The course material covers requirements from the FDA (US), Health Canada, JP (Japan), EMA (Europe), and various guidelines.

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Who can participate?

Anyone interested in gaining basic knowledge of cleaning in the pharma industry.
Personnel in quality, production, development.
New or prospective employees in the Pharmaceutical industry.

Course overview

Confirm Knowledge Center
Havnevej 1, 1 tv, 4000 Roskilde
Danish / English

The teaching material will be in English.
Teaching will be in Danish.

Prerequisites to participate

Course Dates Overview

Date and time Location Language Duration Price
October 26, 2026 Confirm Knowledge Center Danish 1 day DKK 5,500 excl. VAT

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Introduction to Cleaning in Pharma

Cleaning in Pharma is gaining greater attention from inspectors during inspections. This places greater demands on documentation regarding risk assessments and the handling of potential deviations in connection with irregularities during cleaning processes and subsequent analysis of samples.

Participants will have the opportunity to bring their own issues to the table, and there will be case studies and hands-on exercises.

Course information

Teaching method

The course combines theory with practical exercises and discussions based on the participants’ own experiences and challenges. We will be doing exercises on TACT parameters, sampling, and Maximum Allowable Carryover.

We value our students' feedback to ensure the ongoing improvement of our courses.

Course highlights

On the course you will achieve:

The various cleaning methods and sampling techniques used to demonstrate cleaning.
Understanding how acceptance criteria are determined and the effect of hold times.
Difference between cleaning verification and validation.
A risk-based approach to cleaning in connection with, for example, deviation management.
A brief introduction to what is expected of a cleaning validation.

Course program

Introduction
Regulatory framework
Surfaces and Cleaning Processes
Cleaning methods: Manual cleaning; Automated cleaning (CIP, COP, SIP)
Cleaning agents
TACT
Case Studies
Acceptance Criteria
Cleaning Verification and Validation
Summary

After the course

Reviewed rules and guidelines for cleaning in Pharma.
Understanding of various cleaning concepts and their interconnectedness.
Learned how to assess whether a cleaning process is sufficient in case of irregularities.
Assess whether the correct cleaning method and test method have been selected for a cleaning process.

Instructor on the course

Vibe Louise Ernlund Simonsen

Vibe has worked in cleaning for 14 years with both facilities and washing machines in all parts of their life cycles. She has trained many colleagues in cleaning and been part of working groups for deviations and overall SOP descriptions. In addition, she has conducted development studies for use in risk assessments to support and minimize validation activities.

Testimonials from learners

Course participant in Introduction to GAMP 5
Really good and professionally strong presentation. The trainer found the right professional level for the group and initiated good tasks and resulting discussions. And super with small breaks every hour.
Course participant in Introduction to GAMP 5
Many thanks and much praise to Katrine! As a teacher, you are present, relevant, a skilled communicator and very pleasant. You manage to bring your experience from both teaching and practice into play in the context in which we ask the questions.
Course participant in Introduction to GAMP 5
I think it was good to mix the theory and the practical part. The teacher was super good at explaining and super good at pulling out examples that supported the theory.
Course participant in Data Integrity
The benefit of the course is a quick and processed approach to the ISPE guide.
Course participant in Data Integrity
It was a great course that lived up to all expectations. Super good teacher 🙂
Course participant in Data Integrity
Really good course... even after many hours you are still in it... course leader can maintain focus and interest
Student in SattLine Programming
A good structure of course material and balance between theoretical material and exercises. The theoretical parts gives food room for more in depth questions of interested.
Student in SattLine Programming
Very motivated course-responsible, very pationate and patient.
Course participant in Data Integrity
Good with exercises and quizzes. Good location and delicious food/catering.
Student in SattLine Programming
Super teacher 👍😁

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