Knors Pharma Solutions LLP is privileged to share its expertise and collaborate with Biocon Ltd, pioneers in Biotechnology and India’s largest Biopharmaceuticals and Pharmaceutical manufacturing organization, to evaluate and identify improvement opportunities within prevalent QMS and fostering Behavior Based Quality Culture. Biocon is among few reputed Indian organization recognized for their commitment to Quality and Regulatory compliance in India and abroad. The state-of-the-art integrated Drug Substance and Drug Product manufacturing facilities, competent and committed team, over the years, scaled Regulatory approvals from across all major Health and Regulatory Authorities worldwide.
With the commitment to foster and promote Quality Culture and being predominantly a compliance centric organization, the Biocon Leadership team invited Knors to identify areas of improvements in prevalent processes associated with QMS and to evaluate demonstrated quality traits and behavior by the site teams.
The Knors trainers formulated a systematic plan and conducted an on-site assessment upon due authorization from Biocon. A comprehensive report on risk and opportunities was accordingly tabled. Four Training-cum-Workshop sessions on different topics; Preparedness for regulatory inspection, Quality oversight, Training of Subject-Matter-Experts (SMEs) for Regulatory Inspections and Conduct of Investigations based on Scientific Rationale were conducted.
Biocon Team is really fantastic! Biocon personnel participated in the sessions very enthusiastically. KNORS trainers evaluated the training through workshops conducted on the live cases. We consider these successful training sessions at Biocon as a milestone in preparing the pharmaceutical industry personnel for regulatory inspections and implementing the remediation actions.
