Aseptic Process Validation: Top-Tips for Compliance and Success
Learn what FDA, EU and PIC/S expect for cGMP aseptic process validation, the elements of a full validation, and how to plan and accept media fills.
Speaker
Kelly Thomas
cGMP quality and validation consultant · 20+ years in cGMP industry
Overview
Aseptic process validation is what gives manufacturers confidence in a safe, effective finished product, and the work starts with achieving the right sterility assurance for active ingredients and sterile bulk material. This 90-minute aseptic process validation training reviews cGMP requirements and guidance from the FDA, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the EU.
You'll cover the elements of a complete aseptic validation, from container closure integrity and sterilization, filter validation and equipment cleaning to sterility testing, personnel training and environmental monitoring. The session explains media fills and process simulations for liquid, semi-liquid and solid dosage forms, their acceptance criteria, and worst-case conditions and critical interventions.
It also discusses prospective, concurrent and retrospective validation, revalidation, best practices and common deficiencies.
Why attend: Gaps in aseptic validation put sterility assurance and compliance at risk, and regulators expect every element to be covered. Understanding the requirements and common errors helps you build a validation program that stands up to inspection. This session suits operations employees involved in manufacturing, quality control testing and validation, including production, QC microbiology, engineering and validation, facilities and maintenance, and quality assurance.
What’s covered
- FDA, EU and PIC/S guidance on aseptic processing
- Container closure integrity
- Container closure sterilization
- Filter validation
- Equipment cleaning and disinfection
- Equipment maintenance and testing
- Sterility testing
- Personnel training
- Environmental monitoring
- Why media fills and process simulations matter for sterility assurance
- Simulating aseptic processes for liquid, semi-liquid and solid dosage forms
- Validation requirements and acceptance criteria
- Worst-case conditions and critical interventions
- Prospective, concurrent and retrospective validation
- The role of revalidation
- Industry best practices and common errors and deficiencies
Who should attend
What you get
About the speaker
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
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