1、1Mar 30 2022Designing Process Is Easy,Governing Is HarderChris MoriakDirector,Process ManagementAstraZenecaMy name is Chris Moriak,and I am a Director of Process Management at AstraZeneca Pharmaceuticals.I am also an APQC certified process manager.Presented at 2022 APQC Process and Knowledge Managem
2、ent conferenceAstraZeneca Pharmaceuticals case study on how AstraZeneca redesigned and implemented 27 core processes in 12 monthsIts been 3 years since project finished and am here to share the lessons learned.Im here to say that designing process is easy,governing is harder.1How familiar are you wi
3、th APQCs 7 Tenets of Process Management?2New to me?Lets start with a question to get a benchmark within the room on the level of knowledge people have on APQCs 7 Tenets of Process Management.Raise your hand if.1.New to me23Drug Development Builds Stories Not WidgetsDiscoveryDevelopCommercialConduct
4、clinical trialsSafetyEfficacyTo set the background for this talk and for those unfamiliar with drug development:Clinical sits between discovering a new drug and a patient using the drugClinical conducts human studiesUnderstand the drugs efficacy and safetyHighly regulated industry,lots of inspection
5、s and regulatory reviews Drug development build stories,not widgets process is not automated and highly dependent on human engagement and decisions.Inspection and review findings can cause delays,fines,non-approvals,or pulling the drug from the market3APQC Process Analysis and Design Methodology4Pro
6、cess clarityAlignmentCollaborationProcess designStaff performanceContinuous improvementIn 2020,AstraZeneca applied aspects of APQCs process analysis and design methodology to radically redesign R&D Clinicals processes.1.Held workshops to gain clarity on the current and ideal states of the process2.A