In this Recorded On-line Seminar, you will hear the latest thinking on risk management -- and you'll gain an understanding of the concepts and ideas required to begin applying a risk-based approach to electronic records and signatures in your organization. We will describe the risk-based approach to electronic record and signature compliance, including 21 CFR Part 11. We will also cover the wider topic of risk asessment and management in the compliance and validation of compurized systems. The Recorded On-line Seminar will provide valuable background information on how regulators, especially the FDA, are embracing risk-based approaches.

Learning Objectives
At the end of this Recorded On-line Seminar, participants will be able to:

• Apply a risk management approach to achieving compliant electronic records and signatures

Who Should Attend

• IT professionals working in life sciences
• Quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management who need a practical understanding of electronic record compliance
• Computer systems vendors and validation service companies.

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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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