This live and interactive training webinar will focus on the basic issues involved in setting limits for active ingredients in cleaning validation protocols. This is often called the Maximum Allowable Carryover (MAC or MACO) calculation. Setting appropriate acceptance residue limits is a critical elements of an overall cleaning validation program. Limits are established for patient safety and product quality, but may also be set based on production efficiency. Variations on how it is presented or expressed by different companies will be presented. Specific situations in which a safety factor other than 0.001 might be used will be explored. Handling of unique situations like adult/child doses and doses based on body weight (or skin surface area) will be covered. The proper use of “default values” will be explained, as well as alternatives to use for default values. Approaches for highly hazardous actives will be covered. The regulatory basis for these approaches will be discussed.

Learning Benefits:

• Understanding the terminology applied to setting limits for cleaning validation.
• Understanding and applying limits approaches for actives in both drug product and API manufacture.
• Understanding special situations which may require modification of the basic calculations.
• Applying the use of default values.
• Understanding and applying what visually clean means.
• Learn what regulatory documents say about setting limits.

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