Cleaning Validation Fundamentals Robust Strategies for Designing and Improving Cleaning Validation Programs & Latest FDA and European Regulatory Requirements

Cleaning Validation for process equipment product contact surfaces has been a regulatory expectation since the early 1990’s. This live webinar will introduce the learner to the fundamentals of cleaning validation for pharmaceutical manufacturers, including the following topics:

-Definitions and scope
-Regulatory requirements (FDA and European)
-Cleaning process consistency
-Residues and residue limits
-Analytical methods
-Sampling methods
-Protocol options and strategies
-Validation maintenance

This live training webinar is designed to provide a review of current expectations for pharmaceutical cleaning validation. Taught by one of the industry’s global leaders in cleaning validation, the attendee will be engaged in discussions that will provide robust and meaningful strategies for designing and improving their cleaning validation programs.

Learning Benefits:

• Appreciating the various parts of a cleaning validation program that must work together.
• Appropriate design of a cleaning process.
• Understanding and applying terms and concepts correctly.
• Critical elements in setting limits.
• Understanding of the latest regulatory expectations.
• Understanding selection of analytical and sampling methods.
• Integrating all elements for an effective protocol.
• Learning about worldwide regulatory expectations.

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
• Technical Support
• Senior Management responsible for cleaning validation
• Validation