Aseptic Gowning Practices for Pharmaceutical Manufacturing Training Course (PDA 395)

OVERVIEW

Aseptic gowning is one of the most critical controls in sterile pharmaceutical manufacturing. This two-day training program provides a comprehensive blend of foundational knowledge, practical skill building, and competency assessment to ensure personnel can gown correctly, consistently, and in full compliance with regulatory and site-specific requirements.

Through instructor led presentations, demonstrations, hands on practice, and qualification exercises, participants develop both the technical skills and the behavioral discipline required to operate safely within controlled environments.

The training course emphasizes contamination control principles, proper donning and doffing techniques, cleanroom behavior, and the human factor elements that influence aseptic performance. By the end of the program, participants will be prepared to meet the expectations of GMP, FDA guidance, and EU Annex 1 for personnel working in aseptic processing areas.

LEARNING OBJECTIVES

Upon completion of this event, the attendee will be able to:

1. Explain the principles of Aseptic Processing related to aseptic gowning
2. Demonstrate proper aseptic gowning techniques
3. Apply appropriate cleanroom entry and behavioral practices
4. Design and perform a gowning qualification program
5. Identify and troubleshoot gowning related issues

WHO SHOULD ATTEND

This event is intended for professionals who work in, support, or supervise activities within controlled or aseptic manufacturing environments. It is particularly relevant for:

Aseptic Processing Operators responsible for sterile manufacturing, filling, compounding, or component preparation, Cleanroom Technicians who routinely gown and enter classified areas, Quality Assurance (QA) and Quality Control (QC) Personnel involved in aseptic oversight, environmental monitoring, or batch record review. New Employees or Cross‑Training Staff transitioning into aseptic roles or requiring initial gowning qualification and Contractors or Visitors who may need controlled‑area access under supervision.

RELATED EVENTS

PDA TRI Aseptic Processing Events