Why Should You Attend:
This webinar addresses the integrity of records and data used within the regulated industries. This webinar also addresses issues of data privacy. Data integrity has been a focus for regulatory inspections. Many inspection reports from regulatory agencies around the world cite data integrity and data privacy as a cause of observations and enforcement actions. Actions taken by regulators to restrict the commercial activities of manufacturers on the grounds of data integrity or data privacy violations can have very serious consequences for a not-compliant company. This webinar will describe how to achieve data integrity and privacy, implement computer systems in compliance with FDA regulations, and how to validate them. At the end of this seminar the attendees will have knowledge of principles of data Integrity and data privacy based on FDA regulations.
Data integrity has been a focus of regulatory inspections. This webinar describes data integrity and privacy regulations. We will describe how to evaluate and control data integrity and privacy risks. We will talk about CFR Part 11, European equivalent Annex 11, GAMP 5 which deal with controlling risk and managing computer systems over their life cycle. The practices recommended by these regulations will be dealt with in detail, and practical advice will be given.
Areas Covered in the Webinar:
Who Will Benefit:
From the following Industries:
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.
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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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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] call +1-888-717-2436 (Toll Free).
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