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Cleaning Validation in Pharmaceutical Manufacturing Facilities

Cleaning validation is the process of assuring that a cleaning procedure effectively removes the residue (chemical, physical and microbiological) from manufacturing equipment/facilities below a predetermined level. Cleaning validation is primarily used for the cleaning of process manufacturing equipment. 

The webinar will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a “Cleanining Validation Master Plan” and the appropriate documentation for each study to be performed. In addition, requirements for mainenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion. 

Attend this webinar to learn:

  • Cleaning validation concepts
  • Cleaning evaluation and validation in chemical API production and finish products facility
  • Technical and organizational aspects of equipments
  • How to write a cleaning validation protocol

 

  • Speaker

    Gilberto Dalmaso, PhD

    Global Life Science Scientific Officer

    Gilberto Dalmaso has over 25 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK).  In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. Today Gilberto is the Global Life Science Scientific Officer for Particle Measuring Systems, serves on the European PDA Committee, is a reporter to numerous symposia on the microbiology and Pharma in Europe, Asia and United States, and is an ISO 9001 and HACCP quality system auditor.