Thursday February 23, 2012 Thursday February 23, 2012
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| Module 1 Date: Tuesday January 31, 2012 |
| Module 2 Date: Tuesday Feburary 28, 2012 |
| Module 3 Date: Tuesday March 20, 2012 |
| Module 4 Date: Tuesday April 17, 2012 |
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Time: 1:00 PM ET | 10:00 AM PT | Duration: 2.25 hours plus pre-course reading assignment |
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:
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:
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:
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 introduce 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:
This webinar series is designed for Quality Professionals, IT professionals, system owners and system teams.
Dr. Teri Stokes is an International Consultant on the topic of computer systems validation to the pharmaceutical, biotech, and health care industries and their system suppliers. Her special focus is the development of corporate policy and its practical implementation through to project level activities across international sites for systems operating under regulations for GLP, GCP, GMP, and Electronic Records. Successful engagements have been delivered for clients in North America, Europe, and Japan.
Dr. Stokes established her own consulting firm GXP International in March 1996 after more than 16 years with Digital Equipment Corporation where her last assignment was as Director of Computer Validation Services in the Americas. From May 1990 to June 1995, she worked for Digital in Basel, Switzerland and established Digital’s validation services business in Europe. During 1993-95, Dr. Stokes served as a Founding Member on the Board of Directors of the European Forum for Good Clinical Practice (EFGCP) in Brussels, Belgium and participated in the Audit Working Group of the EFGCP.
Prior to coming to Digital in 1979, Dr. Stokes had a 12 year management career in hospital and commercial medical laboratories in the USA. Her introduction to computers came within a GLP environment where laboratory testing for 2,000 patients per day was performed. The computer systems for this laboratory also transmitted report results to 21 remote sites.
In her 16+ years at Digital, Dr. Stokes kept a focus on the pharmaceutical, biotech, and chemical industries across her various assignments. She holds a B.A. degree in Biology from Boston University and a professional registration as a Medical Technologist, M.T.(ASCP). Dr. Stokes received her M.S. degree in Management in 1987 from Lesley University with a marketing thesis on Remote Data Entry in Clinical Trials: Technology ; Market Readiness. In 1991 she received her Ph.D. in Management from Walden University with a Dissertation titled “ Clinical Data Management Trends: New Technologies and EC 1992.;
Professional Memberships:
Drug Information Association (DIA) – Member since 1982and on Core Committees for Validation and GCP/QA
American Society of Quality (ASQ) – Member & Speaker at 2007 Annual Meeting
Institute of Electrical and Electronics Engineers (IEEE) – Member and on Rewrite Committee for Std. 829 Test Documentation
National Institutes of Health (NIH) - Peer Reviewer for grant proposals
Book Author:
Sole author of the book titled The Survive and Thrive Guide to Computer Validation published by Interpharm Press, Inc., Englewood, CO, June 1998. ISBN: 1-57491-067-1 Available at www.gxpinternational.com
Lead Author of the book Good Computer Validation Practices: Common Sense Implementation published by Interpharm Press, Inc., May 1994. ISBN: 0-935184-55-4
Contributing Author to the following books:
Computerized Systems Used in Nonclinical Safety Assessment: Current Concepts in Validation and Compliance published by Drug Information Association, 2008. Chapter 6: Business Continuity and Disaster Recovery.
Pharmaceutical Quality published by DHI Books and PDA Press, June 2004.
Chapter 13: Quality for Computerized Systems and Electronic Data in Regulated Environments.
Automation and Validation of Information in Pharmaceutical Processing published by Marcel Dekker, Inc., New York, NY, July 1998. Chapters 15: GMP Regulations and Computer Validation, Chapter 17: Management’s Role in Computer Validation: Policy and Procedures, Chapter 18. Electronic Records, Electronic Signatures, and FDA Regulation Final Rule.
Multi-Company, Multi-Country Clinical Trials: Implementation, Monitoring, and Regulations published by Interpharm Press, Inc., July 1993. Chapter 12: Information Systems Validation in Global Clinical Trials.
Single Attendee: CAD $195.00
Group of 5 or less per location: CAD $400.00
Group of 6 to 10 attendees per location: CAD $750.00
Group of 11 to 20 attendees per location: CAD $1250.00
Single attendee refers to single participant at a single computer/login.
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.
Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.