Grouping Strategies for Cleaning Validation Using Science and Data-Driven Grouping Approaches to Effectively Accomplish Cleaning Validation & Regulatory Recommendations

Manufacturing efficiency (without compromising effectiveness and compliance) is becoming a key driver for survival and growth in the pharmaceutical and biopharmaceutical industry. One way to make cleaning validation more efficient is to use science and data-driven grouping approaches to effectively accomplish cleaning validation.

There will be an emphasis on understanding the cleaning process, the nature of the products, and the nature of the equipment in making decisions related to grouping. In addition, issues related to the number of validation runs to perform on the representative product or equipment will be covered. Finally, regulatory support for grouping approaches will be explored.

Learning Benefits:

• Understanding the terminology applied to grouping approaches.
• Understanding and applying grouping principles to product grouping.
• How to select worst case products in a grouping approach.
• How to select limits for the worst case product.
• How to add a new product to a group.
• Understanding and applying grouping principles to equipment grouping.
• How to determine equipment equivalence and/or worst cases.
• Pitfalls to avoid in grouping approaches.
• Learn about special cases for grouping (products and equipment).
• Regulatory support for grouping approaches.

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