Validant Case Study

Aseptic Coaching and Mentoring


A global Biopharmaceutical manufacturing company site had multiple FDA citations for aseptic processing deficiencies. They needed an expert partner to help them review their workflows and develop their team to uphold compliance in aseptic operations.


Validant deployed a team of 14 Aseptic Coaches on-site to provide:

  • Training for site Aseptic Quality Coaches in leadership, organizational dynamics and communications
  • Training in best Aseptic Manufacturing Practices and requirements to assure understanding
  • Oversight of operations on a 24/7 basis
  • Direction to the Aseptic Coaching Team to help them develop fully compliant SOPs

With hands-on guidance and boots-on-the-ground execution, Validant:

  • Enabled the client to demonstrate to FDA that they were taking compliant aseptic operations seriously.
  • Educated the site team on regulations and best aseptic practices for long-term success.
  • Maintained coverage of all operations while identifying and hiring FTEs.

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