Industry Leaders Discuss Data Integrity

Industry Leaders Discuss Data Integrity

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On March 29, 2017, the annual Calibration Discussion Group was held at the RTP Foundation on Davis Dr. This one-day event brings together the biopharmaceutical professionals from the industry to share common approaches, issues, and solutions. Industry associates from over twenty operating companies attended this year’s event.

While the majority of the attendees are North Carolina based, this years event include attendees from as far away as Maryland, Illinios, and Colorado.  The keynote speakers from Biogen, Tanisha McClendon and Brian Urban, discussed the importance of quality and integrity throughout the manufacturing process and how data integrity is crucial in the pharmaceutical industry.

 

The theme of this year’s event was Data Integrity, multiple industry subject matter experts led discussion topics which included:

  • Criticality Assessments & Instrument Classifications
  • Establishing Operating Ranges, Instrument Tolerances, and Service Frequencies
  • Key elements of overall calibration & maintenance programs along with criticality of data and data use

The open forum, networking, and presentations resulted in a better understanding of industry trends and common program approaches.

 

The Calibration Discussion Group (CDG) was established in the early 1990’s in response to the lack of training courses offered for instrumentation professionals working in the pharmaceutical industry.  In 1990, local leaders from companies such as Abbott Labs in Rocky Mt, Glaxo in Zebulon, Miles Laboratories in Clayton, and Burroughs Welcome in Greenville, collaborated to form a one-day meeting for pharmaceutical instrumentation professionals.  The leadership of the Calibration Discussion Group consists of regional biopharmaceutical calibration professionals who are addressing the same issues and asking the same questions as their constituency. As a result, the learning technique applied at a Calibration Discussion Group allows attendees to return to their company with information and tools that can be directly applied at their facilities.  In recent years, the attendees have expanded to include professionals from QA, Maintenance, Engineering, and Manufacturing.