Crisis Response And Preparedness - Documentation, IT Systems, Data Integrity In The Current Pandemic Of Coronavirus

Instructor: Eleonora Babayants
Product ID: 706455
Training Level: Intermediate to Advanced
  • Duration: 60 Min
Ongoing coronavirus pandemic is grabbing everyone’s attention, including many scammers. As with other crisis, at this time, more than ever, organizations need to evaluate the potential impact of this crisis on their operations and prepare to deal with pandemic. Crisis preparedness is the high priority in any organization but especially in regulated industries. In this webinar, we will review crisis preparedness procedures for documentation, data security, and IT systems. We will look at data governance procedures and how to implement them, how to successfully safeguard documents and data, and maintain the continuity of IT systems operations during crisis.
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Read Frequently Asked Questions

Why Should You Attend:

In the regulated environment which must be GxP/GMP compliant, data integrity is extremely important, and especially during a crisis such as a pandemic.

Companies need to prevent data breaches from happening. IT systems need to operate to support business needs. Data is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Data provides the route for auditors to assess the overall quality of operations within a company and the final product.

And what if a disaster strikes, such as a pandemic coronavirus? Is your organization ready for pandemic and is able to have continuance of operations? Is your organization prepared to safeguard documents, data and systems from scammers?

Data security procedures should be developed and implemented. It is imperative to secure data, prepare for e-discovery, and be ready if a crisis strikes.

Learn how to secure, manage and govern documents, data as well as IT systems in compliance with GxP/GMP requirements and in the crisis situation. Learn how to ensure that documents, data, and IT systems are in compliance with GxP/GMP requirements and how to prepare for e-discovery and crisis.

Data security is the high priority in any organization but especially in regulated industries. Companies need to safeguard against every possible vulnerability across their entire infrastructure. Documentation, data integrity and governance are never more important as in the time of crisis.

In a situation when threats are directly impacting important services and assets, time is the most precious resource. Whether it’s a cyber threat or a pandemic, every second counts.

Learning Objectives:

Data integrity, data security, and crisis preparedness are high priorities in any organization but especially in regulated industries. Documents, data, and IT systems need to be ready for audits or in case if a crisis like coronavirus happens.

In this webinar, you will learn how to:

  • Implement data security
  • Implement data integrity
  • Implement e-discovery
  • Implement crisis preparedness
  • Secure, manage and govern data
  • Ensure that documents are in compliance with GxP/GMP
  • Ensure that data and IT systems are in compliance with GxP/GMP
  • Ensure that documents, data, and IT systems are able survive the pandemic and maintain normal operations.

Areas Covered in the Webinar:

  • Documents management in preparedness for audits, e-discovery, crisis
  • IT systems management in preparedness for audits, e-discovery, crisis
  • IT Systems Validation
  • Maintenance of normal IT operations during pandemic
  • Information Governance
  • Change Control Procedure
  • Data Security
  • Data Integrity

Who Will Benefit:

  • Quality Assurance
  • Documentation Managers
  • Records Managers
  • Document Control
  • Compliance
  • Medical Affairs
  • IT

From Regulated industries such as Pharmaceutical, Medical Devices, Food, Cosmetics, any other regulated industry and not regulated industries; any industry

Free Materials:

  • Presentation
Instructor Profile:
Eleonora Babayants

Eleonora Babayants
Founder and President, Galaxy Consulting

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.

Follow us :
Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

Refund Policy

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.

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