Summary
The training covers a systematic evaluation and understanding of the requirements of the Contamination Control Strategy as detailed in the EU Annex 1 Manufacture of Sterile Medicinal Products.
Who should attend?
- QC / QA specialists & officers
- Regulatory affairs
- Quality & Validation engineers
- Process validation specialists
- Manufacturing managers & technicians
- Microbiology specialists
- Design Engineers
- Supply Chain specialists
Learning Objectives
- Latest regulations and guidance in respect of Contamination control strategy and sterile medicinal products
- How to implement the CCR within your Quality System?
- The implications of change control and its impact on the CCR
- Understand the different elements of the CCR and their impact on your Quality System
- Gain knowledge and understanding of the successful implementation of the CCS and the impact of failed implementations
- Explore the different roles within the company organization and their inputs to a successful implementation of the CCS
Key Topics
- What is a Contamination Control Strategy (CCS)?
- Prevention of cross-contamination in production
- The Development, Implementation, and Maintenance of the CCS Elements to be considered within a CCS
- Identifying the different controls and monitoring measures employed to manage risks to medicinal product quality and safety
Online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Contamination Control Strategy
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