A Contamination Control Strategy is not a paper exercise with limited input. A holistic approach requires an experienced and reliable knowledge base for each of the systems. The CCS brings all these systems together under its contamination control centric umbrella. As every system in interdependent upon other systems contamination control mindset must be applied universally.

A holistic approach evaluates perceived risks in the design and planning process while actual risks are assessed in the qualification, start up and operational stages.

Join Ziva Abraham & Christian Scheuermann on this workshop to learn best practices, implementation of your own CCS.

What will you learn?

Part 1 – Understanding Current Regulatory Thinking – Ziva Abraham

• What was the CCS prior to EU Annex 1 Draft 2020
• Why a CCS now?
• Why the emphasis on risk assessment and QRM
• Key updates that point to contamination control
• Case studies related to missed risk
• FDA 483 observation that emphasize the need for CCS

Part 2 – Practical Approach to Implementation of CCS – Ziva Abraham

• Where to start with the CCS
• What steps to follow
• Who should be involved for each system
• Holistic review of the documented CCS
• Life cycle of the CCS and periodic review
• Mistakes to avoid

Part 3 – What is an Effective Contamination Control Strategy – Christian Scheuermann

• Microbial ID Methodology – importance of library
• Consistency & MALDI-TOF cases and examples
• Cleaning and Disinfection
• Environmental monitoring
• Prevention & Investigations

Knowledge Exchange

Attendees take part in a round-the-room survey of your company's experience and challenges related to Contamination Control Strategy

Takeaway Tools

• List of expected components of a CCS
• Generic template for CCS
• Relevant white paper(s)