Webinar Details:

For decades, pharmaceutical and medical device manufacturers lacked a dedicated compendial chapter for bioburden monitoring. Microbial Enumeration Tests USP <61> — designed specifically for the release of finished nonsterile roducts under USP <1111> — was routinely, and incorrectly, applied as a generic bioburden method for raw materials, in-process samples, components, and water systems. USP <1229.3> acknowledged that a modified version of <61> might be used for this purpose but offered no specific direction on how to do so, leaving sites to develop inconsistent, loosely justified sampling plans, testing frequencies, and acceptance limits.

USP <1119> ("Bioburden Monitoring") and its companion method chapter USP <1119.1> ("Bioburden Test"), both effective December 1, 2025, close this gap. Together they replace <1229.3> and give bioburden monitoring its own compendial home — one built on process understanding and scientific justification rather than a fixed, prescriptive rulebook. As informational chapters, they do not impose mandatory requirements; instead, they establish a risk-based framework that manufacturers are expected to adapt to their specific materials, processes, and risk profiles, while remaining broadly aligned with FDA expectations and EU GMP Annex 1.

This 60-slide webinar provides a comprehensive, practice-ready introduction to the new framework. It opens with the fundamentals of bioburden — what it is, where it originates, and how it differs from related concepts such as sterility testing, microbial enumeration, and environmental monitoring. It then examines USP <1119> in depth: its scope, its guiding philosophy, and the six core elements of a compliant program — risk assessment, sampling strategy, testing frequency, bioburden limits, method suitability, and trending. A dedicated section unpacks USP <1119.1>'s general aerobic test method, covering membrane filtration, pour plate, and surface spread techniques, media selection, growth promotion and negative controls, and result reporting in CFU, TAMC, and TYMC.

The second half of this webinar translates guidance into practice. Attendees will walk through a step-by-step approach to building or updating a monitoring program, including setting alert and action levels, qualifying rapid microbiological methods, monitoring pharmaceutical water systems, applying bioburden data to sterilization validation, and investigating out-of-limit results. The webinar also situates USP <1119> within the broader global standards landscape — including ISO 11737-1 for medical devices, EU GMP Annex 1, and the complementary USP chapters <61>, <62>, <1111>, and <1115> — before closing with common implementation pitfalls, a practical compliance roadmap, and a discussion of cross-functional roles and responsibilities.

Who should attend:
QA and QC microbiologists, manufacturing and process engineers, regulatory affairs professionals, and quality leaders responsible for contamination control strategies in pharmaceutical, biologics, or medical device manufacturing.

Key learning objectives:

1. Explain how USP <1119> and <1119.1> differ in purpose and scope from USP <61>, <62>, and<1111>
2. Describe the six elements of a risk-based bioburden monitoring program and how to build a scientifically justified sampling plan and limit-setting rationale
3. Apply USP <1119.1>'s general test method, including method selection, validation, and result reporting
4. Identify how USP <1119> intersects with ISO 11737-1 and EU GMP Annex 1, and outline a practical roadmap for bringing an existing program into alignment with the new chapters

Fee:
$385 for one person
$700 2-5 people
$999 6-10 people

Register for ECC-773