A publicly traded generic pharmaceutical company had complicated quality and regulatory management processes with four newly merged entities and two recently lifted FDA Warning Letters. In addition, the training was focused only on GMP.

Our Approach

The team developed a holistic Pharmaceutical Quality System (PQS) strategy and transformation map which would unify the systems and build a roadmap for 3-5 years to meet global regulatory requirements while meeting business need of efficient operations.
The company training was redesigned from GMP-only to a corporate university –model that enabled the company to become a learning organization.
The project results:
  • A new unified corporate quality manual was developed with unified quality standards resulting to easier processes and quality management. Quality management, document management and training management software were integrated providing more efficient workflows and optimized resourcing.
  • The new Corporate University improved GMP training and increased non-GMP skills like Lean, Six Sigma, new product launch, team management and other vital business training.
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