Provisional timetable, the actual schedule may vary depending on the situation
Day 1 - Module 1: Regulatory Requirements and Background
09.00 – 09.15 h Welcome/Introduction
09.15 – 10.15 h
Basic Principles of Microbiology, Hygiene and Contamination Control
- Microorganisms
- Microbial growth
- Characteristics
- Sources
- Basic hygienic Actions
- Cleaning/disinfecting/sterilization
- Way of contamination
10.15 -11.15 h
Regulatory Requirements
- General regulatory requirements and guidelines
- Prevention of contamination and cross contamination
- Requirements for validation
- ISO standards
- Quality Risk Management
11.15 -11.30 h Break
11.30- 12.30 h
Sources of Contamination and Preventive Measures
- Sources of contamination throughout the facility
- HVAC
- Water
- Raw materials and packaging components
- Personnel and clothing
12.30 – 13.00 h
Questions and Answers
13.00 – 14.00 h Break
14.00 - 15.00 h
Effective Training of Operators
- Regulatory requirements (EU-GMP, FDA Guidelines, experiences from inspections)
- Methods and tools
- Measurement and documentation of training success
- Practical approaches
Day 1 - Module 2: Monitoring and Control Strategies
15.00 – 15.45 h
Microbiological Monitoring
Monitoring of non-sterile processes
- Aseptic manufacture:
- developing a programme
- interpreting data
- regulatory requirements
- Monitoring methods, air, surface, people
- A complete programme for a sterile product
15.45 - 16.00 h Break
16.00 – 16.45 h
Microbiological Control of Water Systems
- Water as raw material
- Contamination sources within the water system
- Technical aspects
- Control methods
- Microbiological testing of water
16.45 – 17.30 h
Trending of Environmental Monitoring Data
- How do you do it?
- What do the results really tell you?
- How should you react on the results?
17.30 – 18.00 h
Questions and Answers
Day 2 - Module 3: Personnel Hygiene and Implementation of a Cleaning/Disinfection Strategy
08.30 – 09.30 h
Cleaning and Disinfection of Surfaces
- Criteria of selection of disinfectants
- Rotation of antimicrobial substances considering their chemical interaction
- Cleaning potential of disinfectants
- Users acceptance
09.30 - 10.30 h
Qualification of Disinfectants
- Different gassing systems
- Guidance documents, standards and regulatory requirements
- Basis for qualification
- Case study for qualification of disinfectants
- Efficacy – how to control?
10.30 - 10.45 h Break
10.45 – 11.45 h
Hygiene of Personnel – Cleanroom Behaviour
- Contamination from personnel
- Classic employee deviance
- Gowning procedure
- Hand disinfection
11.45 -12.15 h
Questions and Answers
12.15 – 13.15 h Break
13.15 – 14.15
Case Study: Managing Disinfection Programmes
- Hygiene programme
- Cleanroom concept
- Demands on environment, equipment and personnel
- Cleaning and disinfection concept
14.15 – 15.00 h
Case Studies: Disinfections Issues
- Practical examples of microbial deviations after cleaning and disinfection activities.
- Root causes and pitfalls
- Measures for troubleshooting in practice
- Preventive measures to avoid errors
15.00 – 15.15 h Break
15.15 – 16.15 h
Handling of Microbiological OOS/OOL Results
- Failure investigation
- Following corrective actions and preventive actions
16.15 – 17.15 h
Cleanroom Garment, Requirements, Selection and Laundering
- Different fabrics and their characteristics like filtration capacity and wearing comfort
- Garment systems oriented by the cleanroom class
- Requirements on decontamination and laundering
- Outsourcing
17.15 – 18.00 h
Questions and Answers
Day 3
08.30 – 09.30
Validation of a Decontamination System for Production Equipment, Process Devices and Cleanrooms
- Technical requirements & Background
- Qualification of a fogging system
- Validation of a fogging process
Module 4: Additional Challenges
09.30 – 10.30 h
Cleanroom Consumables - a so called „Cent-Product“ but with Consequences
- Definition of cleanroom consumable products
- The impact during the daily application
- How is that reflected in guidelines?
10.30 – 10.45 h Break
10.45 – 11.45 h
Quality Risk Management
- Risk Assessment:
- Risk Identification
- Risk Analysis
- Risk Evaluation
- Risk Management
11.45 – 12.45 h
Contamination Control Strategy - An Interdisciplinary and Dynamic System
- Formulate a CCS
- Implement a CCS and develop a strategic plan to make the strategy work as intended by mapping/designing the organizational structure, procedures, control processes, distributing resources, developing the decision-making processes, etc.
- Evaluate the CCS efficiency to ensure process performance and product quality while improving the CCS level over time.
12.45 – 13.30 h
Questions and Answers