Aseptic Processing and Validation Course: A Must for Pharmaceutical Manufacturers

Understanding the Importance of Aseptic Processing

Aseptic processing is a critical operation in pharmaceutical manufacturing that involves the production of sterile products. This process requires strict control and adherence to regulatory requirements to ensure the quality and safety of the final product. The “Aseptic Processing and Validation Course – FDA Expectations and Industry Best Practices” provides an in-depth review of process design, contamination control strategy, risk assessments, and validation approaches aligned with FDA’s Guidance for Industry, EU Annex 1, and ICH Q9/Q10 principles. Why Attend This Course?

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.

1. Gain Tools for Managing Deviations: Learn how to identify and address deviations in aseptic processes, and develop strategies for responding to FDA observations.
2. Implement Effective CAPAs: Understand how to develop and implement Corrective and Preventive Actions (CAPAs) to address aseptic issues and prevent future occurrences.
3. Ensure Inspection Readiness: Acquire the knowledge and skills necessary to ensure your facility is inspection-ready, and able to respond to FDA findings.

“The aseptic processing industry is highly regulated, and companies must demonstrate that their operations consistently produce sterile products under strict control. This course provides the tools and knowledge necessary to ensure compliance and quality.” – Meredith Crabtree, Owner of MLKC Consulting

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

1. Day 1: 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
2. Day 2: 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

Join the Course Today!

For more information about this training, visit https://www.researchandmarkets.com/r/tdqibc. Don’t miss the opportunity to ensure your facility is inspection-ready and compliant with regulatory requirements. Register for the “Aseptic Processing and Validation Course – FDA Expectations and Industry Best Practices” today!