: 20 Nov 2019 - 22 Nov 2019
: Barcelona, Spain
In pharmaceutical manufacture, cleaning and disinfection measures are important and decisive process steps for fulfilling the quality requirements of medicinal products. The lack of control of microbiological contamination is an outstanding integral part of inspection findings.
This ECA education course is designed to cover all important aspects of controlling microbiological contamination. It ranges from sources of contamination to validation of cleaning and disinfection processes and training of operators.
Module 1 Requirements and Background
- Basic Principles of Hygiene and Microbiology
- Regulatory Requirements
- Sources of Contamination and Preventive Measures
- Microbiological Monitoring
- Trending of Environmental Monitoring Data
- Microbiological Control of Water Systems
- Qualification of Disinfectants
- Cleaning and Disinfection of Surfaces
Module 2: Implementation and Issues in Real Life
- Case Study: Managing Disinfection Programmes
- Hygiene of personnel – Cleanroom Behaviour
- Validation of a Decontamination System for Production Equipment, Process Devices and Cleanrooms
- Quality Risk Management
- Cleanroom Garment, Requirements, Selection and Laundering
- Effective Training of Operators
- Cleanroom consumables - a so called "cent product" but with consequences
During the second day, parallel workshops will be conducted in order to reinforce the content of the lectures and to discuss practical aspects in detail.
Workshops will be offered on the following topics:
1. Disinfection Issues.
2. Handling of OOS Results