Training
These are some examples of the types of training conducted, although many other options for custom training are available.
- Sterilization and Sterility Assurance
- Training
- Sterile Process Validation Packages (site, and regulatory submissions)
- Sterilization Microbiology
- Moist and Dry Heat Sterilization Validation
- Sterilization of Commodities
- Factors to Biological Indicator Variability
- Steam Sterilization Cycle Development
- Environmental Monitoring for Aseptic Filling
- Product Contamination Testing
- Container Closure Integrity Testing
- Handling Aberrant Sterilization Cycles
- Depyrogenation
- LAL Basics and Oven Depyrogenation
- Washing to Achieve Depyrogenation
- Responsibility for items received “depyrogenated”
- Aseptic Processing
- Aseptic Processing
- Good Aseptic Technique
- Troubleshooting Validation Problems, Media Fills, Sterility Failures
- Environmental Monitoring and Control
- Design of Systems
- On-Going Monitoring
- Rapid Methods for Environmental Monitoring
- Microbiology
- Basic Microbiology
- Pharmaceutical Microbiology Requirements
- Pharmaceutical Microbiology for Engineers
- Automating your laboratory
- Ways to Improve Laboratory Procedures
- Rapid Microbiological Methods
- Biological Indicators
- Validation of Rapid Microbiology Methods
- Microbiology Laboratory Training
- Microbiology for Non- Microbiologists
- Regulatory and Quality Training
- Good Manufacturing Practices (GMPs)
- GMPs for specific areas (e.g., labs, manufacturing, documentation, packaging)
- Good Documentation Practices (GDPs)
- Best Practices for Laboratories
- Quality Problem Solving
- Writing, Developing Comparability Protocols
- The Validation Master Plan
- Writing SOP’s
- Writing Validation Plans
- Preparing for FDA and other regulatory Inspections
- Systems Based Inspections
- Quality By Design
- Development of Quality Systems
- Quality Engineering Course
- Quality Manager Training
- Software Validation Requirements
- Risk Based Manufacturing
- Auditing Facilities
- Conducting Audits
- Annual Product Reviews
- Specific Regulatory Guidance Documents, e.g., ICH, WHO, GMPs