21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
Website https://www.demystifiedsolutions.com/trainingDetails/21-CFR-Part-11-Electronic-Records-Signatures-Co |
Deadline: May 26, 2017 | Date: May 26, 2017
Updated: 2017-03-10 15:49:37 (GMT+9)
Call For Papers - CFPThis webinar will help you understand in detail the application of FDA’s 21 CFR Part 11 compliance guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.Why Should You AttendYou should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations that uses ER/ES capability, or if you are maintaining or supporting such a system.Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.There is an enormous body of documentation and information available that can be overwhelming. This webinar will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques and tools available.Areas Covered in this WebinarGain an understanding of FDA’s 21 CFR Part 11 guidance document for electronic medical records trainingDevelop the ability to apply 21 CFR Part 11 when implementing, and maintaining computer system validation in your organizationUnderstand the best practices for maintaining a computer system with ER/ES capability in a validated stateDiscuss the best practices necessary to ensure all systems with ER/ES capability are validated appropriatelyLearn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk, as it applies to the use of ER/ES capabilityUnderstand how to effectively document the process of computer system validation where ER/ES capability exists, and maintain current information about the various systems in your organization and how they are maintained in a validated stateLearn how to gain information about trends in ER/ES validation, as industry progresses and new best practices emergeUnderstand some of the key “pitfalls” to avoid when employing ER/ES capabilityLearning ObjectivesGet an understanding of how to adhere to 21 CFR Part 11 guidelines when planning, executing and maintaining computer system validationDevelop a sound strategy for meeting FDA complianceUnderstand the level of effort required for executing each phase of the System Development Life Cycle methodology, as it pertains to ER/ES capabilityThe appropriate level of documentation that must be completed to support itGain an understanding of the training and skills required to apply 21 CFR Part 11 to systems when validating or maintaining themLeverage these practices across all systems by creating a standardized program for applying 21 CFR Part 11 guidelines to systems in accordance with FDA requirementsWho Will Benefit- Information Technology Analysts- QC/QA Managers and Analysts- Clinical Data Managers and Scientists- Analytical Chemists- Compliance Managers- Lab Managers- Automation Analysts- Computer System Validation Specialists- GMP Training Specialists- Business Stakeholders- ConsultantsFor More Info, Please Click below URL:https://www.demystifiedsolutions.com/trainingDetails/21-CFR-Part-11-Electronic-Records-Signatures-Compliance-for-Computer-Systems-Regulated-by-FDA-DEMY051459
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