Lessons Learned in Computer System Validation: A Project Manager’s Perspective -By AtoZ Compliance

Key Take Away:

This pharmaceutical validation training reviews the requirements for computer validation, including the industry-accepted collection of documentation which constitutes a validation package.


Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records is a critical requirement of electronic record compliance, as described in the FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4.

The webinar will discuss user requirements, functional specifications and design specifications, requirement traceability, risk assessment, creating appropriate testing protocols, summary reports, and how to maintain your validated systems, skewed towards the information a Project Manager needs to develop an executable project plan.

Why Should You Attend:

Every pharmaceutical manufacturing facility utilizes Computer Systems, and for a Project Manager, these systems may be foreign to them. Even though there is a saturation of training on what Computer System Validation is, there is little training for a Project Manager to discover what the key elements of a project plan MUST be to support a successful project completion. Countless hours are wasted explaining PLC and HMI and how procedural controls are important to their use, as well as software and hardware requirements. The lessons learned in this webinar are intended to help a Project Manager (or anyone involved with capital projects) to recognize, address and mitigate those real risks associated with computer system validation, the NUMBER ONE cause of schedule slippage on many projects.

Areas Covered In This Webinar:

Project Initiation and Planning

Project Management
Software Development Life Cycle (SDLC) Process Definition
Gap Assessments
Risk Assessments
Validation Master Planning (VMP)
System Requirements and Design

User Requirements Specifications (URS)
Functional Specifications (FS)
Design Specifications (DS)
Design Review
Supplier/Vendor Audits
System Development and Verification

Leveraging of Vendor Documentation
Unit Testing
Integration Testing
System Testing
Factory Acceptance Testing (FAT)
Site Acceptance Testing (SAT)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Requirements Traceability
System Operation

Backup and Recovery
Data Archiving
Continuity Planning
Disaster Recovery
Change and Configuration Management
Incident and Problem Management
Periodic System Reviews
Best Practices Training
FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4
Risks to project scope, schedule and budget
Computer System Validation basics
Critical issues related to CSV on large capital projects
Finally, REAL WORLD lessons learned from a half dozen installation will be presented. For each of these, the presentation will discuss cause and effect.
Learning Objectives:

Computer System Validation is an area foreign to most capital projects Project Managers. This webinar will present REAL WORLD lessons learned from the management of dozens of projects in the area of Pharmaceutical Manufacturing Facility construction.

A detailed description of typical requirements will be presented, but more importantly, this webinar will address what that means to a Project Manager and the Project Team. It will give introduction to critical issues and discuss and present case study lessons learned.
Who Will Benefit:

Quality Assurance





Project Management


For more information, please visit :  http://bit.ly/2rPaoOj
Email: support@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509
Speakers Profile:

Keith Gibbs
Mr. Gibbs is a highly motivated leader with a proven project management track record. Able to interface with and motivate people at all levels of an organization or project and across all business units, he works diligently on the application of best practices. He possesses an extensive experience organizing and supervising the business activities of project teams, within budget and to tight timetables. An innovative thought leader who is well respected by industry peers for creative and applicable solutions to complex problems, he has proven planning and brainstorming expertise that has established a framework for successful projects and business practices.

Mr. Gibbs is a sought after trainer and educator who has a gift for motivating fellow professionals to reach their peak performance. Through many years of in the field experience, he possesses a full and applied understanding of the business of consultancy support to industry.

As the owner of Ninja Project Management, Mr. Gibbs relies on his eighteen years of experience in Project Management, Engineering, Construction Management, Commissioning & Qualification (Verification), Validation, Quality Assurance, and Pre-Operations Management Support for the pharmaceutical, biotechnology, semiconductor and utility generation and transmission industries, to help clients succeed. Typically, responsible for the management of cGMP or specialty projects that involve start-up, commissioning, qualification and validation, he is best utilized for short-term, fast track, complex projects. His greatest strength is applying his expertise to projects that need to be brought back on track, and he is a recognized leader for project salvage and restoration planning. To support these tasks, he is involved in the preliminary design review, constructability review and master planning activities to ensure the integration of all phases of a project in the support of turnover, start-up, Quality Assurance and Validation requirements.

In his career, he has managed the design, installation, start-up and qualification of utility, facility, control and process systems for laboratories and pharmaceutical manufacturing facilities. A leader in the integrated approach to commissioning and qualification, he has extensive experience in authoring and executing test plans and protocols. A unique specialty is the development of leveraged Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) plans as part of integrated Commissioning/Validation efforts. Another hard earned specialty is the extensive experience in deviation resolution.

Mr. Gibbs has managed teams from 2 to 40 direct reports on projects from $50,000 to $50,000,000. He has supported innovative projects with full life-cycle involvement, as well as task focused short cycle assignments.

In his free time, he runs a small business, Raleigh Llama Salvage and Restoration, where he seeks out and restores items and artefacts of interest to him. He is an avid disc golfer and enjoys time with his family.


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