Following activities can be provided:

• 2 -3 days Workshops about Hot Topics in Sterile Production/ Aseptic Processing/ QA & QC Microbiology
• Media Fill / Environmental Monitoring / Sterility Testing Expertise
• Troubleshooting in Microbiological Testing Deviations (Sterility Testing/ Media Fill/ EM)
• Effective Training and mentoring of Clean Room Operators at the Shop Floor (Videos/ Reports/ ...)
• Man in Plant Activities
• Start Up of new Sterile Plants and Utilities (Microbiology QA/QC Activities)
• Terminal Sterilisation Expertise
• Risk Assessments for Aseptic Processing 

Sterile Product Compliance Risk Analysis 

• HAZOP or FMEA Risk Assessment of Sterile/ Aseptic Production plants and Microbiology QA/QC systems
• Results : Total Risk Factor or Risk Priority Numbers, and provide technical solutions and set CAPA´s
• Target: improve the quality of the sterile / aseptic process to prevent
  • non- sterile product on the market
  • regulatory non- compliance in audits
• CAPA Effectiveness Verification 

Support in FDA Audit Preparation / Remediation process

• Preparation for FDA and regulatory agency audits 
• Support in FDA enforcement action remediations, including Form 483s, Warning Letters 
• Mock audits 

Support in Due Diligence / Supplier Audits 

Extensive expertise in Microbiological QC labs and Sterile API and FDF Manufacturing, including Solid Product Filling