Annex 1 - Contamination Control Strategy

Operations Quality Assurance @Biotech Training Facility

The current Annex I and the accompanying Contamination Control Strategy (CCS) must be properly understood by management and staff and, more importantly, implemented and complied with. This is to ensure consistent batches with a minimum risk of contamination.

Location

Biotech Training Facility

Duration

1 day

Course fee

€ 995.00 (excl. VAT)
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Short description

This training covers Annex I in combination with Contamination Control Strategy and the most important microbiological concepts in the pharmaceutical industry:

  • Annex I: what is Annex I and what has changed

  • Contamination Control Strategy: what is it and how do I create a good CCS

  • Quality Risk Management and Root Cause Analysis

  • Microbiology and disinfection

  • Cleanroom principles

  • EM techniques

Participants in this course will learn what Annex I requires and how to implement it correctly. The challenge lies in the fact that micro-organisms are always present, everywhere. Controlling their introduction and growth requires a good understanding of the risks, microbiological sources and living conditions.

Objectives

  • Gain a thorough understanding of Annex I and the Contamination Control Strategy

  • Know how to perform a risk assessment and root cause analysis related to contamination control

  • Have a good understanding of the sources and environmental conditions of microorganisms

  • Know the purpose of the different contamination control mechanisms and the impact if they do not function properly

  • Know which activities during the manufacture of sterile and non-sterile products are critical in keeping the introduction of microorganisms under control.

Target group

  • Staff (analysts, operators) who execute activities in classified areas.

  • Quality officers, managers, supervisors, who would like to gain a clear and practical insight into the pharmaceutical microbiology.

Program

Register now!

Stay up to date with the most important microbiological concepts in the pharmaceutical industry and sign up for this practical, interactive course.

Annex 1 - Contamination Control Strategy

Invoice addressed to

Invoice details

Course fee
€ 995.00
VAT 21%
€ 208.95
Total incl. VAT
€ 1,203.95
By continuing, I agree with the terms and conditions

Review

GMP Production with Annex 1

Ron van der Linde (Implementation Lead Production)
Score 9.0

26-27 March 2025 HAL Allergy I want to thank you enormously for last week's training. I am getting a huge number of compliments about the training. From both groups. The trainers really did their utmost. The material was of good quality. There was always a relaxed atmosphere that involved everyone. The Annex 1 was well explained : the why and also which consequences it entails in practice. I also found the refresher course very useful. We were sometimes surprised by the different ways there are of doing things. Lunch was excellent. In short, 2 very useful days.

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