Contamination Control Strategy
WHY SHOULD YOU ATTEND?
Grab a systematic evaluation and overview
of CCS requirements as detailed in the EU Annex 1 Manufacture of Sterile Medicinal Products.
Gain knowledge and understanding
on the successful implementation of the CCS and the impact of failed implementations.
Recognise the different elements of the CCS
and how they impact on your Quality System. Check the latest regulations and guidance.
Apply the different roles
within the company organisation and their inputs to a successful implementation of the Contamination Control Strategy.
OUR ONLINE TRAINING EXPERIENCE INCLUDES
Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
LEARNING OBJECTIVES
Why is CCS critical in maintaining appropriate controls of contamination?
Overview of the latest regulations and guidance of contamination control strategy and sterile medicinal products
Review of the different elements of the CCS
Design of the plant and processes including the associated documentation. Premises, equipment, utilities.
Raw materials, packaging and vendor management elements of the CCS
Raw material controls. Product containers and closures. Vendor approval and outsourced activities.
Review of process related elements of the CCS
Process risk management, process validation, validation of sterilisation processes, preventative maintenance.
Cleaning, monitoring and prevention elements
Cleaning and disinfection, monitoring systems, prevention mechanisms, continuous improvement.
Case study group exercise
Changes in the supply chain sourcing model for a key component in vial products leads to increased risk.
WHO IS THIS TRAINING FOR?
QC/QA Specialists
Quality & Validation Engineers
Process Validation Specialists
Microbiology Specialists
Design Engineers
Supply Chain Specialists
Regulatory Affairs Managers
Manufacturing Technicians
KEY TOPICS
Introduction to Contamination Control Strategy
Development and Implementation of the CCS Elements
Managing Risks to Medicinal Product Quality
Prevention of Cross-contamination in Production
Identifying the Different Controls and Monitoring Measures
Evaluation and Understanding of CCS Requirements
TRAINER
PAST PARTICIPANTS
Contamination Control Strategy
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
