New: Contamination control strategy (CCS)

Target audience:

Employees from the pharmaceutical or life science sector who are involved in the development, implementation, or optimization of a Contamination Control Strategy (CCS) in an aseptic or GMP environment.
This includes, among others: QA/QC staff, operators, supervisors, project managers, engineers, and validation/qualification specialists who work with cleanrooms, production processes, and microbiological quality assurance.

Learning objectives:

This training provides participants with a thorough understanding of the concept of a Contamination Control Strategy, in line with EU-GMP Annex 1 and the requirements of regulatory authorities such as the FDA and EMA.
It covers the what, why, and benefits of a robust CCS, including its importance for product quality, patient safety, operational efficiency, and market success.

Participants will learn:

• How to build a CCS based on risk assessments
• Which elements are crucial for an effective strategy
• How to align processes, facilities, and personnel to minimize contamination
• Practical tips and examples for implementing or improving a CCS in their own work environment

Programme:

Theory

• Introduction: What is a CCS and why is it mandatory?
• EU-GMP Annex 1 and expectations from FDA/EMA
• Key elements of a CCS (including personnel behaviour, facilities, equipment, cleaning/disinfection, monitoring)
• Risk assessment and risk control
• Examples of successful CCS implementations
• Benefits: product safety, operational efficiency, cost savings, market position

Practical application

• Analysis of a sample CCS
• Exercise: developing a risk assessment for a process or facility
• Discussion and exchange of best practices among participants

Price:
€395.00 per person (excl. VAT)

Location:
The training takes place at the GxP Academy, Advipro headquarters: Wechelsebaan 143 unit 13, 2275 Lille.

Registration required:
Via the contact form below.

Student?
Don’t hesitate to contact us so we can explore available options.