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Regulatory Requirements and Principles for Cleaning Validation (California, United States - December 7-8, 2017) - Research and Markets
[October 24, 2017]

Regulatory Requirements and Principles for Cleaning Validation (California, United States - December 7-8, 2017) - Research and Markets


The "Regulatory Requirements and Principles for Cleaning Validation" conference has been added to Research and Markets' offering.

This two day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaeutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.



Areas Covered in the Session:

  • Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product
  • Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
  • Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
  • Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies

For more information about this conference visit https://www.researchandmarkets.com/research/8lb37v/regulatory



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