The Management of a Global Quality System in a Central Laboratory

Transcription

1 The Management of a Quality ystem in a Central aboratory Mario Zanata Manager OP dministration, Regulatory Training and rchives Rome, 4 th October 2005 genda Company Introduction Company Quality ssurance Management in a Central aboratory. 1

2 Covance Drug Development ervices stablished industry's first Central aboratory ervices business in Covance Central aboratory ervices (CC) Fully dedicated to clinical trials within the Drug development Industry. Dedicated to testing specimens, resulting and reporting data. aboratory ervices ogistics Data Management Project Management 2

3 Covance Central aboratory ocations ocation stablished Operate in 6 locations, serving all continents Indianapolis, Indiana Geneva, witzerland ingapore Zeist, Netherlands Cape Town, outh frica Johannesburg, outh frica ydney, ustralia ão Paulo, Brazil CC: a Company Organisation Responsabilities Processes nalytical Methods Combinable Data G O B H D Worldwide responsiblity for a specific department. nsures processes and procedures are harmonized. liminates local (site level) specificities and inconsistencies. Implement Processes. 3

4 CC Quality ssurance Vision upport and ensure full compliance and operational excellence of global CC activities through: Proactive Quality uditing, Quality Tracking Management and Q and Regulatory Training Programs Full Compliance to Regulatory Requirements by: everaging the understanding of compliance, quality, regulatory risk and providing direction and strategy Q Management at CC means Main Components 6: ICH GCP aboratory ccreditations OP ystem dministration uditing rchiving Quality Tracking and Management QC xternal Programs Regulatory and Q Training G O B H D Q Core Functions Quality Compliance Quality Tracking & Management Quality ssurance Operations 4

5 Quality Compliance Objective: nsures global processes are implemented, compliant to internal OPs/ystems and are adequately implemented and interpreted. Conduct audits Report findings Facilitate implementation of corrective and preventative actions. Responsible for Regulatory and Inspection preparedness. Host ponsor udits uditing Team Q uditor Training Program Quality Tracking Management (QTM) Objective: Function within Q that manages and oversees the Quality Complaint Management (CP) process for CC, ensures root cause is identified and corrective and preventative actions are implemented. Central repository that collects, tracks and trends quality issues (external customer complains and internal service failures). QTM to ensure causal factors are identified and corrective and preventative actions are implemented. QTM reports are presented and reviewed monthly with the CC xecutive Committee. 5

6 Quality ssurance Operations OPs dministration Regulatory Training rchives Quality ssurance Operations OP dministration OP dministration centralized in one site Unique OP dministration Database OPs available to users on the Intranet Centralized Communication H R D R P O N I B I I T I Heads are responsible for implementation of OPs for their departments OP Team responsible for the administration of the OP Process 6

7 Quality ssurance Operations Regulatory and Q Training Objective: nhance Q and Regulatory awareness throughout Training on Q strategic topics Trainings provided to all employees. Training Catalogue ICH GCP principles Q Introduction for new hires Q Delegates OP Process Training Files Documentation Practices Quality ssurance Operations rchives Objectives nhance rchiving requirements for: Physical security on the archives Record retention duration valuates and implements a rchiving strategy 7

8 Quality ssurance network xternal support to Q activities Q delegates iaison with departments Coordination and control of Training Files upport to the Implementation of OPs Participation with Q informational meetings Contact person between Q department and the other departments Conclusions Q Compliance QTM Organisation Responsabilities Processes Q Operations nalytical Methods Combinable Data 8