List of Lectures
ECA - Micobiological Best Laboratory Practice:
- Microbial Limit Test for Non-Sterile Products
- Test Test for Specified Organisms
- Harmonized Methods for Testing of Non-Sterile Products (Workshop Session)
- Rapid Microbiological Methods
- Method Validation according Ph. Eur. 5.1.6.
ECA - Contamination Control:
- Basic Principles of Hygiene and Contamination Control
- Sources of Contamination and Preventive Measures
Concept Heidelberg – Efficient data management in microbiology (M9):
- Statistical methods in microbiology
- Limit setting (Workshop session)
- Efficient management of microbiological sampling plans
- Efficient sampling plans for testing non-sterile products (workshop session)
- Case studies: Improvement of running times in the laboratory with Lean Six Sigma
Concept Heidelberg – Microbiological test methods. GMP-compliant application and validation (M2):
- Detection of specific microorganisms and their identification
- Microbiological environmental controls
Concept Heidelberg – GMP fundamentals of sterile production (S4)
- Clean rooms/isolators/RABS- Personal hygiene
- Cleaning and disinfection
- Workshop: processing case studies
- Inspection and audits for sterile production
Heipha – Practical training for fungus identification
- Mould in the pharmaceutical field
Heipha – GMP basis: General microbiology & hygiene
- Microbiological quality control
- Personal hygiene
- GMP-compliant documentation
- Workshop GMP & microbiology
- Requirements for pharmaceutical products
- Microbiological monitoring
Heipha – Performance test of disinfectants
- Disinfectants: Basis and definition
- Use and inspection of disinfectants
Heipha – Microbiological high-speed methods and their validation
- Chapter 5.1.6 – modern microbiological methods
- Overview of the current methods
Heipha – Microbiological testing of non-sterile pharmaceuticals with exchange of experiences:
- Background and current trends towards the chapter for microbiological testing of non-sterile products
- Challenges with culture media
- Workshop: Exchange of experience
Swiss Cleanroom Concept – Requirements of ventilation technology:
- Mikrobiologische Reinraumqualifizierung und Monitoring
