Aseptic Processing Training Certificate Program (PDA 100)

Please note that this event has hands-on lab activities. Please wear long pants and closed-toe shoes.

OVERVIEW

The Aseptic Processing Training Certificate Program (PDA 100) is a rigorous, industry-aligned educational experience designed to prepare professionals for the critical responsibilities involved in sterile pharmaceutical manufacturing. Aseptic processing is a cornerstone of modern pharmaceutical production, particularly for injectable drugs, biologics, and advanced therapies where maintaining sterility is essential to product safety and efficacy. This 5-day program provides a comprehensive foundation in the science, technology, and regulatory expectations that govern aseptic operations.

Participants will gain a deep understanding of contamination control, cleanroom behavior, aseptic technique, and environmental monitoring, all within the framework of current Good Manufacturing Practices (cGMP). The curriculum is structured to bridge theoretical knowledge with practical application, ensuring that learners not only understand the "why" behind aseptic practices but also develop the hands-on skills necessary to execute them with precision and consistency.

The program is designed and delivered by subject matter experts with extensive experience in sterile manufacturing, microbiology, quality assurance, and regulatory compliance. It incorporates real-world case studies, interactive workshops, and simulation-based learning to reinforce key concepts and promote critical thinking. Whether participants are new to aseptic processing or seeking to deepen their expertise, this program offers a structured pathway to competence and certification.

In addition to technical training, the program emphasizes the importance of quality culture, human factors, and risk-based decision-making. Participants will explore how deviations, environmental excursions, and operator errors can impact product sterility, and how to apply root cause analysis and CAPA (Corrective and Preventive Action) strategies to maintain control. The program also covers the latest updates to global regulatory guidance, including FDA aseptic processing guidance and EU GMP Annex 1 revisions, ensuring that learners are equipped to meet evolving compliance expectations.

Upon successful completion of the program, participants will receive a Certificate of Completion in Aseptic Processing, demonstrating their readiness to work in or support aseptic manufacturing environments. This credential is valuable for professionals in manufacturing, quality, validation, engineering, and regulatory roles, and is often required for personnel working in Grade A/B cleanroom areas.

Participants who have attended the 2-week “Mastering Aseptic Processing Training Course (PDA 100)” between 2020-2025 are eligible to receive a Certificate of Completion in Aseptic Processing upon request.

LEARNING OBJECTIVES

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

1. Apply microbiological principles to aseptic processing and contamination control
2. Understand environmental monitoring program components, regulatory requirements, and proper sampling technique
3. Apply knowledge of aseptic gowning principles, cleanroom fill operations, cleanroom behavior, and aseptic technique
4. Assess potential risks of product contamination in a cleanroom using airflow visualization techniques
5. Demonstrate proficiency in cleaning and disinfection techniques using validated methods
6. Explain the role and execution of filter integrity testing
7. Demonstrate understanding of isolator/RABs design and bio-decontamination by designing a validation process
8. Understand the principles behind sterilization and explain the importance of proper sterilization wrapping, cycle development, and validation for moist heat sterilization
9. Interpret and apply global regulatory requirements (e.g., FDA, EU Annex 1) for aseptic manufacturing

WHO SHOULD ATTEND

This event is intended for professionals who are involved in sterile product manufacturing and quality assurance, including:

• Manufacturing and operations personnel working in aseptic environments
• Quality assurance and quality control professionals
• Microbiologists and environmental monitoring specialists
• Validation and process development engineers
• Regulatory affairs and compliance staff
• Training and technical services professionals
• Individuals new to aseptic processing or transitioning into sterile manufacturing roles

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