Annex 1 - Contamination Control Strategy

Operations Quality Assurance @Biotech Training Facility

The current Annex 1 and the associated Contamination Control Strategy (CCS) form the foundation for managing contamination risks within pharmaceutical manufacturing. To ensure consistent product quality and minimize the risk of microbial, chemical, and physical contamination, it is essential that employees, managers, and quality professionals understand the principles of Annex 1 and are able to implement them effectively. 

Location

Biotech Training Facility

Duration

1 day

Course fee

€ 995.00 (excl. VAT)
Sign up

Short description

During this intensive one-day training course, participants will gain insight into the background, requirements, and practical application of Annex 1. The course covers the historical development of the guideline, the regulatory framework, cleanroom technology, monitoring, microbiology, aseptic processes, and the development and implementation of an effective Contamination Control Strategy. 

 

The training combines theory with practical examples and covers, among others: 

  • The principles, background, and key changes introduced in Annex 1 

  • The regulatory framework and its relationship with the Pharmaceutical Quality System 

  • Cleanroom design, air handling, and personnel and material flows 

  • Cleaning, disinfection, qualification, and facility monitoring 

  • Contamination Control Strategy (CCS): structure, content, and implementation 

  • Sources of contamination and the basic principles of pharmaceutical microbiology 

  • Environmental Monitoring (EM) 

  • The role of personnel as a source of contamination 

  • Aseptic manufacturing processes, media fills, and isolator technology 

  • Practical implementation of Annex 1 within the organization 

Objectives

Upon completion of the training, participants will be able to: 

  • Explain the principles, background, and key requirements of Annex 1. 

  • Describe the structure and purpose of a Contamination Control Strategy (CCS). 

  • Understand the relationship between Annex 1, CCS, and the Pharmaceutical Quality System. 

  • Identify and assess the main sources of contamination. 

  • Apply the basic principles of pharmaceutical microbiology to contamination control. 

  • Explain the importance of cleanroom design, air handling, monitoring, and personnel behavior. 

  • Recognize the key considerations for implementing Annex 1 within their own organization. 

Target group

This training is intended for: 

  • Operators, analysts, and technicians working in classified areas or sterile manufacturing environments. 

  • QA, QC, and validation personnel involved in contamination control and compliance activities. 

  • Team leaders, supervisors, and managers responsible for the implementation of Annex 1 and CCS. 

  • Employees seeking to expand their knowledge of pharmaceutical microbiology, cleanroom technology, and aseptic processing. 

Note: Participants are expected to have a basic understanding of GMP. In addition, experience with or familiarity with working in a cleanroom environment is required. 

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 I - Contamination Control Strategy

Invoice addressed to

Invoice details

Course fee
€ 995.00
VAT 21%
€ 208.95
Total incl. VAT
€ 1,203.95

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.

Sign up