Education Sessions

E-FE1a & b
Legacy Systems: Maintaining a State of Qualification
(Two Successive Sessions)

4 November 12.30-14.30
4 November 15.00-17.00		 Track: Facilities and Engineering

ISPE CEUs: 0.4

Explore the challenges of maintaining a state of qualification throughout the operational lifecycle of systems and equipment. Case studies will provide remediation methods utilized to successfully rebuild asset engineering and maintenance history information and reclaim a state of qualification. In an interactive workshop, learn how to gather lifecycle qualification information.

Implications of the new ASTM Standard Guide for Science-and Risk-based Approach to Qualification of Biopharmaceutical and Pharmaceutical Manufacturing Systems on legacy equipment and lifecycle requirements are discussed. Ongoing discussion of this session’s topics continue via the ISPE Commissioning and Qualification Community of Practice discussion forum on Maintaining the State of Qualification.

Take Back to Your Job

  • Understand business processes required to maintain a state of qualification
  • Apply effective remediation processes and technology tools that can be used to rebuild asset design and maintenance information required to support requalification
  • Understand and implement solutions from novel situations, and understand the impact of the ASTM Standard Guide for Science-and Risk-based Approach
    to Qualification of Biopharmaceutical and Pharmaceutical Manufacturing Systems on maintaining a qualified state for legacy systems

Who Should Attend

Individuals involved with operating or maintaining legacy systems supporting biopharmaceutical or pharmaceutical manufacturing operations. This session is of interest to a multidisciplinary audience, including engineering, operations, maintenance, quality, qualification/validation, and operations management.

Agenda

  • Participant Workshop: Identify and Gather Issues
  • Case Study: Reclaiming the Qualified State
  • ASTM Standard: Implications for Legacy Equipment Requalification
  • Question and Answer with Panel

Session Leader

Session Speakers

 

Sponsors