Why Should You Attend:
Software validation is not just a regulatory necessity. It is fast becoming a necessity for the device industry's increasingly software-controlled environments.
Many companies struggle with understanding how to avoid major mistakes and inspection risk when validating software to FDA standards. This webinar will review the validation planning process with emphasis on avoiding common pitfalls. The attendee should leave the presentation confident in their ability to improve the level of validation success.
If data becomes invalid, based on improperly validating and maintaining the system that houses it in a validated state, the work related to the data would need to be repeated. This could result in a devastating loss to a company.
Learn how to develop the appropriate IT systems validation strategy. Understand how to effectively document the process of IT systems validation, and maintain current information about the various systems in your organization. We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation.
This webinar will focus on how to properly validate FDA regulated IT systems in order to ensure that security and data integrity objectives are met and FDA enforced compliance is met. We will discuss IT Systems Validation approach based on FDA requirements.
We will walk through the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer systems, and will also discuss 21 CFR Part 11, European equivalent Annex 11, GAMP 5 which deal with controlling risk and managing computer systems over their life cycle including validation. We will discuss what is needed to prepare for an FDA inspection of computer systems and data.
Areas Covered in the Webinar:
Who Will Benefit:
From Regulated industries such as Pharmaceutical, Medical Devices, Food, Cosmetics, any other regulated industry and not regulated industries; any industry
Galaxy Consulting Founder and President Eleonora Babayants has many years of GxP/GMP hands-on experience in regulated industries. She worked with quality assurance and compliance officers to develop and execute compliance strategies and programs. She participated in the implementation of compliance requirements.
Her many years’ experience includes regulatory compliance, internal and external auditing, change management, documentation and records management, document control, electronic document management systems, information governance, IT systems management and validation.
Eleonora’s past work includes development and implementation of regulatory compliance policies, processes, and procedures, leading implementation and administration of document control and document management systems in full compliance with regulatory requirements, designing and implementing electronic documents workflows, leading enterprise content management initiatives, enabling enterprise search, improving systems information architecture, creating and implementing users’ training programs.
Eleonora ensured document management systems compliance with regulatory requirements. She collaborated with users to develop positive and productive approaches to regulatory compliance, coordinated, prepared, and participated in internal and external audits including FDA audits.
Eleonora’s experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected]e.com call +1-888-717-2436 (Toll Free).
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