Control of microorganisms by effective cleaning processes is important for both non-sterile and sterile manufacturing processes. This interactive live training will focus on the issues involved with bioburden and other related microbiological topics for cleaning validation. It will start with a discussion of why we address microbiological issues in cleaning validation, as well as ways to control bioburden. It will then cover setting limits, sampling, and sampling recovery studies. A major focus of microbiological issues for many regulatory guidelines is prevention of bioburden proliferation following cleaning and before use. Various clean hold time issues, such as ways to minimize proliferation and to set acceptance criteria, will be addressed. Bioburden in cleaning validation is also one of the main ways that companies can leverage data from other studies based on the new FDA process validation guideline. Finally, related biological concerns, such as endotoxin, will be discussed.

Learning Benefits:

• Understanding the terminology applied to bioburden for cleaning validation.
• Learn control measures for bioburden during the cleaning process.
• Understanding and applying swab and rinse limits for bioburden, including carryover calculations and industry standard practices.
• Understanding limits determination for endotoxins based on industry standard practices.
• Understanding and applying sampling and sampling recovery studies.
• Evaluating bioburden during clean hold time studies.
• Learn what regulatory documents say about microbiological control.

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