Session Type: Recorded Webinar
Knowledge Element: Information Systems
Speaker: Sion Wyn, Director, Conformity Ltd. 
Duration: 60 minutes

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The increased use of information technology and computer systems in all aspects of business is leading to the automation of more and more processes. Key decisions and actions are routinely being taken using Information Systems (IS), with regulated records being generated and maintained electronically throughout the product life-cycle.

This Webinar aims to give the participant practical knowledge of the following:

1. Data management systems of different types and how they are used
2. Knowledge of the basic computer system life cycle model and activities
3. Knowledge of system data integrity and security measures, such as back-up, archiving, and retention requirements

System types covered include Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and Electronic Document Management Systems (EDMS).

The approach is based on guidance published by GAMP – an ISPE Community of Practice. Relevant GAMP Guidance includes the GAMP Guide to Validation of Automated Systems, and the GAMP Good Practice Guide: A Risk Based Approach to Compliant Electronic Records and Signatures.

Learning Objectives:

• Recall Data Management systems of different types
• Explain how such systems are used
• Recall how such systems can impact product quality and patient safety
• Explain the basic computer system life cycle model and the activities that make up the life cycle
• Recall the regulatory requirement for and data integrity and system protection
• Explain data integrity and security measures, such as access control, back-up, and archiving

Who should attend:

• Pharmaceutical professionals who use IS systems
• Quality Assurance Personnel
• IS System Owners
• Validation Specialists
• Management of all levels
• System Suppliers
• IT Specialists

Speaker Biography

Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international regulations. He has extensive experience in all aspects of computer systems validation and compliance, including managing validation projects, validation planning, specification and testing of systems, performing site and system compliance audits, writing SOPs, performing 21 CFR Part 11 assessments, and supplier audits. Wyn’s expertise as a specialized computer validation consultant covers all stages of the lifecycle approach to validation of computerized systems and most system types including MRPII, manufacturing execution, electronic document management, EBRS, process control and monitoring, environmental monitoring, manufacturing equipment, and laboratory systems. At Conformity Ltd., Wyn provides computer validation and compliance consultancy to the pharmaceutical and other regulated healthcare industries.

What is a Recorded Webinar?

Previously held webinars are available as recorded sessions, which you can view at your convenience. Registration orders are processed within two business days, after which participants will receive an e-mail confirmation with a link to the Recorded Webinar. After receiving the link to the Recorded Webinar, you have 15 days to view it.

What are CPIP^SM Recorded Webinars?

CPIP^SM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry Professional^SM (CPIP^SM) examination..

The Certified Pharmaceutical Industry Professional^SM (CPIP^SM) credential recognizes “change agents” as the necessary ingredient to foster industry innovation and enhance drug product quality. The credential establishes a global competency standard for industry professionals, and candidates are assessed through demonstrated education, experience, and a rigorous examination. Completion of any of these seminars does not guarantee successful completion of the CPIP certification exam, and these seminars do not include every subject to the depth of what will be covered on the CPIP exam.

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