Webinar Pack Pack of THREE: Best Selling Webinars by GlobalCompliancePanel Actual Price:
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21 CFR Part 11 - Compliance for Electronic Records and Signatures his webinar details the regulation and how it applies to computerized systems.
Instructors:
Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for
David Nettleton FDA Compliance Specialist
software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.
Excel Spreadsheet Validation To Eliminate 483s This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs.
Validation and Use of Excel Spreadsheets in FDA Regulated Environments Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for regulated environments. However, with a good knowledge of Excel capabilities combined with good procedures and practices on how to validate and use Excel requirements can be met. For example, the FDA is widely using Excel and complies with its own regulations.
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David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects. ..more Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. .. more
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