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Pradeep K Adapala

Director and Head of Validation
Pradeep K Adapala
Director and Head of Validation

Director and Head of Validation

Pradeep K Adapala

Pradeep founded Divas Consultancy LTD. in 2015 and has over 15 years of experience in the Life science industries predominantly as a Validation Consultant.

Pradeep holds B.Pharmacy from Osmania University and MSc in Drug Design and Biomedical Science from Napier University, Edinburgh, UK.

Pradeep has extensive experience in Commissioning, Qualification and Validation (CQV) of Facility, Utilities and Equipment (FUE) by applying Quality Risk Management (QRM) principles, Computer Systems Validation (CSV), Data Integrity, Process Validation / PPQ, Laboratory systems validation, Technology Transfer and Scale-up. Pradeep is well aware of regulatory expectations, experienced with audit readiness and supported various regulatory audits throughout his career which includes (but not limited to) MHRA, US-FDA, HPRA and client audits.

Some of the major capital /redevelopment projects that Pradeep was part of are:
  • Aseptic Filling Line remediation project at Alexion, Ireland
  • Automatic Robotic Filling Line project including Super-Heated Water Steriler (SHWS) and RFID Truck Transportation System with full traceability of the product at Baxter Healthcare, UK.
  • Sterile Products Manufacturing Facility (SPMF) expansion project (New Filling Line Project) at Wockhardt, UK.
  • Successfully qualified Purified Water (PW), WFI and Compressed Air (CA) system modifications, process vessels, new decontamination chamber and vial washer at BPL, UK. Part of new isolator aseptic filling line project main line equipment: Filling and stoppering machine, isolators, Freeze Dryers, Automatic Loading and Unloading System, SCADA.