Webinar On 21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated
- Start Date:
- Thursday, 5 May, 2016
- End Date:
- Thursday, 5 May, 2016 2:00pm
- Internal Medicine, Physical Medicine, Business Practice, Health & Nutrition
Description :This seminar will help you understand in detail the application of FDA's 21 CFR Part 11 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.Areas Covered in the Session :Gain an understanding of FDA's 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidance documentDevelop the ability to apply 21 CFR Part 11 when implementing, validating and maintaining computer systems 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 capabilityInteractive Q&A SessionWho Will Benefit:This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco.
Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:Compliance and Audit ManagersInformation Technology AnalystsInformation Technology Developers and TestersQC/QA Managers and AnalystsClinical Data Managers and ScientistsAnalytical ChemistsLaboratory ManagersAutomation AnalystsComputer System Validation SpecialistsGMP Training SpecialistsBusiness Stakeholders/Subject Matter Experts Business System/Application Testers
5939 Candlebrook Ct,
ON L5V 2V5,
Conference organized by Compliance Trainings
This new 2-day Seminar on Computer Systems Validation will explore proven techniques for reducing costs associated with implementing, using, & maintaining computer systems in regulated environments. The FDA performs GxP & Part 11 inspections, with an updated Annex 11 regulation, & companies must update their systems and processes to maintain compliance.
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