Aseptic Processing and Validation Course - FDA Expectations and Industry Best Practices

WHY YOU SHOULD ATTEND:

Aseptic processing failures have led to some of the most severe FDA enforcement actions in recent years—including 483s, Warning Letters, and product recalls. This course is essential for anyone responsible for sterile product manufacturing, quality assurance, validation, or inspection readiness.

Attendees will learn how to mitigate risks through proper gowning, material transfer, environmental control, and process simulation. Emphasis will be placed on process validation strategies, cleanroom behavior, air handling systems, and microbial contamination control. Through practical examples and case studies, the training reinforces how to implement compliant, inspection-ready aseptic practices that ensure product quality and patient safety.

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Quality Control Departments
• Manufacturing (Sterile/Parenteral) Departments
• Operations Departments
• Engineering Departments
• Aseptic Manufacturing Supervisors
• Regulatory Affairs Departments
• Validation Engineers
• Microbiologists
• Sterility Assurance Professionals
• Environmental Monitoring Technicians
• Site Heads and Plant Directors
• Compliance Departments

DAY 1 (9 AM to 2 PM)

Fundamentals of Aseptic Processing

• Definitions: aseptic vs sterile vs terminal sterilization
• Regulatory requirements (FDA, EU Annex 1, WHO)
• Cleanroom classification and facility design
• Personnel training and gowning qualifications
• Material and equipment flow
• Critical utilities: HVAC, HEPA, compressed gas
• Contamination control strategy
• Environmental monitoring program (EM, alert/action levels, trending)
• Cleanroom behavior and aseptic technique
• Case studies of FDA 483s related to aseptic failures

DAY 2 (9 AM to 2 PM)

Validation and Ongoing Compliance

• Process simulation/media fill validation
• Qualification of personnel (initial and ongoing)
• Cleanroom qualification and air pattern visualization
• Process validation stages (PPQ) for aseptic products
• Smoke studies: purpose and execution
• Risk assessments (FMEA) in aseptic operations
• Deviation handling and root cause analysis
• CAPA for aseptic issues
• Requalification and change management
• Inspection readiness and responding to FDA findings

Meredith Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.