Contamination Control Strategy

Overview:

The requirement of Contamination control strategy is a key requirement as per Eudralex Volume IV Annex -1.

A Contamination Control Strategy (CCS) should be implemented across the facility in order to define all critical control points and assess the effectiveness of all the controls (design, procedural, technical and organisational) and monitoring measures employed to manage risks to medicinal product quality and safety. 

The combined strategy of the CCS should establish robust assurance of contamination prevention. The CCS should be actively reviewed and, where appropriate, updated and should drive continual improvement of the manufacturing and control methods. 

Its effectiveness should form part of the periodic management review. 

Why should you Attend:

The learning objectives are firstly understanding and practical implementation and development of Contamination control strategy for sterile preparations. 

The benefits are, 

• Improved understanding with practical approach for implementation about Contamination control strategy
• Protect the organization  from the potential non conformity or citations
• Improved product and process control and protect from contamination

Areas Covered in the Session:

• Brief introduction of the topic and scope in pharmaceutical industry
• FDA Citations
• Regulatory Expectations
• Key aspects of Good CCS
• Details on Sources of contamination
• 16 bullets to focus for compliance to CCS
• Assessment of intrinsic hazards
• Facility and process related failures
• Failure to control strategy
• Q&A 
• Vote of Thanks and contact details

Who Will Benefit:

• Quality Assurance
• Quality Control
• Pharmaceutical IT compliance
• Global QA
• corporate QA and QC
• IT Personnel working or related to Pharma IT Support