Maximize efficiency and effectiveness in your validation projects by utilizing multi-disciplinary teams. The term “Validation,” as used in this white paper, will be taken to mean either or both activities of Qualifying systems and facilities as fit-for-purpose (IQ/OQ/PQ) and the Process Validation of manufacturing processes and procedures (PQ or PV).
Lean project management strategies incorporate subject matter experts (SMEs) in cross-functional teams. For example, commissioning equipment with computerized functions needs to be validated by the computer systems validation SME and the commissioning and qualification validation SME. This white paper discusses some considerations for using a multi-disciplinary team approach to sitewide or corporate Validation project planning, oversight, execution, and approval.
Table of Contents
Overview of Multi-Disciplinary Validation Teams
Establishing Validation Teams
Complexity and Scope
Criticality and Risk
Availability of Required Personnel
Organizational Experience Level
Time and Project Length
The establishment and management of multi-disciplinary validation teams are crucial to managing changes in the modern Pharmaceutical and Biopharmaceutical industries. These teams are typically responsible for the review, planning, and approval of changes (additions of or modifications) to equipment, facilities, systems, and processes with the potential to impact product quality. Project Management can significantly impact project quality, cost, and time through the decisions and mechanisms they choose to implement. Third-party resources and service firms can help with current developments in industry practices and standards and have the potential to more than pay for themselves in terms of money and time saved.
PSC Biotech® Project Management
PSC Biotech® project management experts have a strong track record of delivering projects and offering the best solutions for all kinds of projects in the life science industry. We follow current Good Practice regulations, the Project Management Institute’s Best Practices, and ISPE’s Good Practice Guides. Our Project Life Cycle services include project initiation, planning, execution, monitoring and controlling, and closure. Throughout the Life Cycle of a project, our primary focus is on delivering our project, on time, on budget, and to specifications.
Download the Multi-Disciplinary Validation Teams for GXP Projects White Paper today!
Validation (IQ, OQ, and PQ) of the HVAC system Reconnection
PSC Biotech provided exceptional professionalism in project planning and time management, qualification document designing, and the executive power of completing qualification tests and solving qualification deviations.
PSC Biotech® delivered a detailed service quotation including personnel, transportation, and accommodation to our client, a global biopharmaceuticals development and manufacturing company located in Taiwan.
Temperature Controlled Chamber Qualification
PSC consultants performed qualification protocol and summary generation, and qualification execution.
PSC Biotech provided CQV and Metrology services for this project. Client required rapid use of refrigerated storage trailers to handle warehouse overload. Each trailer required sensor calibration, engineering study for temperature profile, installation qualification, and operational qualification with temperature mapping. PSC consultants performed the calibration, ran engineering studies, wrote and executed qualification protocols, resolved deviations, and closed out reports.
PSC Software Solutions
PSC Biotech Services provide fast, budget-friendly, high-level expertise.
Share, Engage, Stay Current
The 5 Most Common Data Migration Pitfalls
A Data migration is a daunting, but necessary task when companies undergo digital transformations. PSC Software®’s implementation experts have created this guide to help companies identify and understand the challenges of data migration. In this whitepaper, you’ll...
How to Ace Your Inspections: Keys to Inspection Readiness
On-site and Remote Inspection Management Regulatory inspections can be some of the most intense and stressful activities on a highly regulated company’s path to commercial success. Learn what to expect from an on-site or remote audit, how to prepare to eliminate...
Innovations in Validation: Advancing Cell and Gene Therapies
With the ever-changing mechanics of innovation in the manufacturing environment, work from home and federal regulation validation strategies need to evolve to accommodate the new space. This white paper provides the background, rationale, and strategy for innovating...