The objectives of this live training webinar are to focus on the issues related to chemical analytical methods and analytical method validation for cleaning validation purposes. A validated analytical method is a key part of a cleaning validation program, since it is used to establish that the cleaning process consistently is below established residue limits. Both specific and non-specific methods (including HPLC, TOC, UV and conductivity) with their advantages and limitations will be covered. Newer direct surface analytical procedures will also be described. Appropriate method validation parameters will be covered as they apply to different methods. Topics include dealing with interferences and unknown peaks, using visual examination as an analytical tool, and applications of different methods during the validation lifecycle (from design to validation maintenance). Finally, the regulatory basis for proper use of analytical methods will be discussed.

Learning Benefits:

• Understanding the terminology applied to analytical methods and their validation for cleaning validation uses.
• Understanding appropriate uses of specific and non-specific analytical methods.
• Utilizing visual examination as an “analytical” technique.
• Use of analytical methods during the validation lifecycle, including during design/development, qualification and continued process verification.
• Learn what regulatory documents say about analytical methods.

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