Froggy Jumps S.T.A.R.Online version Pharma ops case study by Creactive 1 **S** – *Last year, our Phase II trial for a new oncology drug was delayed by 6 weeks due to missing patient data.* The Task (T) is a Hire more doctors. b Write a new drug formula. c Reduce the delay to under 3 weeks without losing data quality. 2 Action (A) a I created a daily data tracker in Excel and trained 5 site coordinators via Zoom. b The CRO team worked weekends. c Management sent reminders. 3 Result (R) a Staff learned Zoom. b Trial resumed after 2 weeks and met EMA submission deadline. c Excel looked professional. 4 **S** – *In Q1 2025, our Hungarian API plant faced a 3-day raw material shortage for a key contraceptive ingredient.* The Task (T)is to a Change the product formula. b Close the plant temporarily. c Secure enough API to avoid any production stop for the month. 5 Action (A) a I contacted two backup suppliers in India, negotiated express air freight, and updated SAP stock ale b Suppliers delivered late. c Production ran slower. 6 Result (R) a India learned about Richter. b SAP was updated. c Production continued at 100% capacity and we shipped 1.2 million packs on time. 7 **S** – *During an unannounced GMP audit at our Debrecen site, inspectors found 2 critical CAPA deviations.* The Task is a Train every employee. b Close both CAPAs within 15 working days to avoid warning letter. c Rewrite all SOPs. 8 Action (A) a Inspectors left early. b QA team panicked. c I led daily root-cause meetings, assigned 8 cross-functional actions, and uploaded evidence to the p 9 Result (R) a Portal worked well. b Meetings were short. c Both CAPAs closed in 12 days; auditors sent “no further action” email.
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