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

Description

Aseptic processing is one of the most critical and tightly regulated operations in pharmaceutical manufacturing. This 2-day advanced course explores FDA expectations and industry best practices for aseptic technique, facility design, personnel qualification, environmental monitoring, and media fill validation. With increasing scrutiny from FDA and global regulators, companies must demonstrate that their aseptic operations consistently produce sterile product under strict control.

This course 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. Participants will gain tools for managing deviations, responding to FDA observations, and implementing effective CAPAs in aseptic environments.

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,…