The ECA Contamination Control Strategy Guide - How to use? - Online Training Recording

Course No. 21718



Dr. Ingrid Walther

Dr. Ingrid Walther

Pharma Consulting Walther

Dr. Franz Schönfeld

Dr. Franz Schönfeld

Regierung von Oberfranken

Katharina Stoib

Katharina Stoib

Roche Diagnostics


In addition to the regulatory expectations and the general structure and application of the ECA Contamination Control Guide, this workshop explains how to use the included template for a CCS document and examples for the practical creation of a CCS document. Practical experience will be shared how to use the template to integrate your existing system of contamination control measures and how to evaluate possible gaps.


The final revision of EU GMP Annex 1 contains, among many other innovations and additions, a clear requirement for a contamination control strategy. This refers to a series of measures to control microbial load, pyrogens and particles, derived from the current product and process understanding, implemented to ensure process performance and product quality. The Contamination Control Strategy should include parameters and attributes related to APIs, excipient and drug product materials and components, facility and equipment operating conditions, in-process controls, final product specifications and associated methods and frequency of monitoring and control. A total of 16 elements to be considered is listed in Annex 1.

The requirement in the current Annex 1 for a CCS is the first time that an overarching concept has to be in place and been demanded of manufacturers that integrates the various contamination control measures into a coordinated concept. This concept considers these measures, which are often the responsibility of different areas of the company such as production, quality assurance or quality control, in their entirety. This takes account of the fact that these measures and individual concepts interact with each other and that changes often have an impact on other areas. Like a butterfly effect.

Therefore, the ECA has prepared a guiding document to support you in drawing up such a contamination control strategy. It can be used for both, the coordination of measures for an existing plant and for the creation of a CCS for a new plant.

Target Group

The workshop is aimed at all employees of the pharmaceutical industry who are involved in the preparation of a CCS and also at representatives of the regulatory authorities, involved in the inspection of the fulfilment of such requirements.

Technical Details:

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.


Inspector’s View on a CCS
  • Requirements of Annex 1
  • Inspector´s expectations
  • Implementation: CCS integration in existing environment
The CCS Template – Practical Use Part 1
  • The aim of the Guideline
  • Structure of content structure in connection with Annex 1
  • Structure of the Template/Attachment3
The CCS Template – Practical Use Part 2
  • Practical Use - Filling in the Template
  • Gap-assessment based on the Template
  • Ready to present your CCS
Case Study: Use of the Guide and Template with Integration of Existing Risk Assessments and SOPs
  •  Practical use of the CCS Guide
  •  Evaluation of existing relevant documents
  •  Building an hybrid CCS by integrating existing Risk Assessments and SOPs
Recording from 27 March 2024
Duration of Recording: 2h 25min

ECA-Member*: € 590,-
Regular Fee*: € 690,-
EU/GMP Inspectorates*: € 345,-
APIC Member Discount*: € 640,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

Further dates on-site
Further dates on-site
Not available
Further dates online
Further dates online
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0

Woman with headset

Go back

Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023


“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024


“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024



“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023