Effective sampling is a key to a robust cleaning validation program. This live training program will describe the various sampling options, such as swabbing, rinsing and placebo sampling. It will cover issues related to the selection of sampling methods, including the limitations of each method. Particularly for swab sampling, parameters and practices that help achieve greater consistency in swab results will be explored, including use of multiple swabs on a given swab area. Once sampling methods are selected and designed/developed, it becomes necessary to train and/or qualify the samplers, again to assist in obtaining consistent results. Options for training and subsequent qualification of swab operators will be covered. Recovery studies for both swab and rinse sampling will be described. Issues related to the spiking parameters and conditions, as well as to the number of spiked levels for recovery studies, will be discussed. Finally, what regulatory documents say about sampling and sampling recovery will be covered.

Learning Benefits:

• Understanding the applicability of different sampling methods.
• Understanding features, benefits, and limitations of different sampling methods.
• Learn how to control swab sampling for consistent results.
• Pitfalls to avoid in swab and rinse sampling.
• Designing effective and efficient recovery studies.
• How to train and qualify samplers.
• Regulatory issues in sampling.
• Handling variables such as different surfaces, areas, and limits in recovery studies.

Who should attend:

This live training webinar is applicable to drug product manufacturers and API manufacturers, including biopharmaceutical manufacturers. The following individuals or disciplines involved in process equipment cleaning validation will benefit from attending this live webinar:

• Directors, Managers, Supervisors, Scientists, Technicians
• Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs Personnel
• Senior Management responsible for cleaning validation
• Microbiology Personnel