Tuesday, January 10, 2012 at 1 PM
Module #1: Webinar 2.25 hours plus pre-course reading assignment
Title: Successful Computer Validation 01 - Purchasing a system
Computer validation success begins with the purchase process for a new system. This interactive webinar introduces both non-IT and IT professionals to an industry standard for purchasing strategic software and applies it to purchasing GXP software system options, e.g., software for internal systems, Software as a Service (SaaS), and outsourced CRO software and data services. The first step for both a purchase and a validation is recording user requirements (URS). A table based method for documenting traceable requirements and testing strategies will be presented. Case study examples and assignment will exercise the URS process. A pre-course reading assignment of two chapters from Dr. Stokes new book Computer Validation: A Common Sense Guide will form the basis for a round table discussion of Management’s role in computer validation and the User team’s role in computer validation.
Webinar Format: 60 minute interactive tutorial plus 45 minute case study work and 30 minute instructor facilitated round table discussion by participants.
Course Materials: An electronic briefing unit from Dr. Stokes’ new book Computer Validation: A Common Sense Guide is used for pre-course reading, case study materials, and round table discussion topics. Purchase separately by going to www.BioPharm-Guides.com to order Working Brief Unit 2. This will be a pdf download of Chapter 2 Management’s role in Computer Validationand Chapter 3 User Team’s role in Computer Validation. Read the unit before the webinar.
Participants will be able to do the following from this course:
- Apply a standard process for purchasing strategic software
- Write reality-based User Requirements Specifications (URS)
- Describe all roles and responsibilities for a validation effort
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Tuesday, January 31, 2012 at 1 PM
Module #2: Webinar 2.25 hours plus pre-course reading assignment
Title: Successful Computer Validation 02 – Validation Strategy and Setup for Success
Validation success is defined as validation that assures the system works reliably as expected and that it passes audits and inspections without critical findings. This interactive webinar introduces both non-IT and IT professionals to an industry standard strategy for computer validation to any GXP regulatory requirement – GCP/GLP/GMP/Annex 11/Part 11. It describes the three main workflows needed to validate a system and the rationale for having separate Validation and Test Plans and Summary Reports. A case study will use examples to help participants assess the variations needed for internal systems, SaaS systems, and outsourced CRO systems.
Webinar Format: 60 minute interactive tutorial plus 45 minute case study work and 30 minute instructor facilitated round table discussion by participants.
Course Materials: An electronic briefing unit from Dr. Stokes’ new book Computer Validation: A Common Sense Guide is used for pre-course reading, case study materials, and round table discussion topics. Purchase separately by going to www.BioPharm-Guides.com to order Working Brief Unit 3. This will be a pdf download of Chapter 4 The Auditable Computer Validation Package. Read the unit before the webinar.
Participants will be able to do the following from this course:
- Identify three streams of workflow in making an industry standard validation package
- Describe different goals and structure for Validation and Test Plans and summary reports
- Define relevant strategies for internal systems, software as a service (SaaS), and CRO systems
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Tuesday, February 28, 2012 at 1 PM
Module #3: Webinar 2.25 hours plus pre-course reading assignment
Title: Successful Computer Validation 03 – Formal Testing and Documentation
Testing is only one of the three workflows in computer validation, but it is always a major focus of inspector interest and is an easy source of errors and citations. This interactive webinar will help you prepare testing strategies and documentation that are inspection ready and audit-proof. It introduces both non-IT and IT professionals to the structure of an industry standard set of test documentation: Test Plan, Trace Matrix, Test Script, and Test Summary Report. It describes how the end user’s GXP work process can be used to test for system suitability, reliability, and robustness. Full scale examples from real projects will be used to illustrate concepts for case study and round table discussion purposes.
Webinar Format: 60 minute interactive tutorial plus 45 minute case study work and 30 minute instructor facilitated round table discussion by participants.
Course Materials: An electronic briefing unit from Dr. Stokes’ new book Computer Validation: A Common Sense Guide is used for pre-course reading, case study materials, and round table discussion topics. Purchase separately by going to www.BioPharm-Guides.com to order Working Brief Unit 4. This will be a pdf download of Chapter 5 Auditable Formal Testing Practices. Read the unit before the webinar.
Participants will be able to do the following from this course:
- Discuss Test Plan structure and strategy within the whole validation context
- Design a Trace Matrix and develop test scripts with all audit-required elements included
- Identify auditable components of a Test Plan and Summary Report
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Tuesday, March 20, 2012 at 1 PM
Module #4: Webinar 2.5 hours plus pre-course reading assignment
Title: Successful Computer Validation 04 – Passing Audits and Inspections after Go-Live
Go-live is not the end of validation. It is just the start of keeping the system in a validated state throughout its operational phase and into its retirement and archive. This interactive webinar introduces both non-IT and IT professionals to the roles and responsibilities of an ongoing validation team and the functions of Quality Assurance and Quality Control. It addresses the following questions: What system changes do we need to document and how do we do this? How can we reuse test scripts? What is the difference between Business Continuity and Disaster Recovery? What are the different roles for QA and QC? How do we host a system audit?
Webinar Format: 60 minute interactive tutorial plus 45 minute case study work and 30 minute instructor facilitated round table discussion by participants.
Course Materials: An electronic briefing unit from Dr. Stokes’ new book Computer Validation: A Common Sense Guide is used for pre-course reading, case study materials, and round table discussion topics. Purchase separately by going to www.BioPharm-Guides.com to order Working Brief Unit 7. This will be a pdf download of Chapter 8 Quality Assurance and Quality Control Roles. Read the unit before the webinar.
Participants will be able to do the following from this course:
- Identify ongoing validation practices required to maintain a system’s validated status
- Define the different roles for QC and QA and for BCP and DRP
- Describe the hosting process for system audits and inspections.
Dr. Teri Stokes