Aseptic Processing and Validation Course: A Must for Pharmaceutical Manufacturers

The "Aseptic Processing and Validation Course - FDA Expectations and Industry Best Practices" is 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.

This course is essential for anyone responsible for sterile product manufacturing, quality assurance, validation, or inspection readiness, and helps mitigate risks through proper gowning, material transfer, environmental control, and process simulation.

Emphasis is placed on process validation strategies, cleanroom behavior, air handling systems, and microbial contamination control.

Gain tools for managing deviations and develop strategies for responding to FDA observations through proper training and best practices.

Implement effective Corrective and Preventive Actions (CAPAs) to address aseptic issues and prevent future occurrences.

Ensure inspection readiness by acquiring the knowledge and skills necessary to respond to FDA findings and maintain compliance.

The course covers aseptic processing fundamentals, regulatory requirements, cleanroom classification, and facility design.

It also covers validation strategies, including process simulation, media fill validation, and smoke studies, as well as risk assessments and deviation handling.

The speaker, Meredith Crabtree, is a quality consultant specializing in regulatory assessments and quality trainings.

Register now for the "Aseptic Processing and Validation Course - FDA Expectations and Industry Best Practices" to ensure your facility is inspection-ready and compliant with regulatory requirements.