Data Integrity and Privacy for FDA Regulated Industries

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.

Learning Objectives:

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.

Attendees will:

• Understand what data integrity is and why it is so important for patient safety
• Recognize that there are many causes of data integrity breaches
• Learn current regulatory expectations about data integrity and privacy
• Learn how to maintain data integrity throughout the data life cycle.
• Appreciate the difference between static and dynamic records, and be able to apply acceptable strategies for the retention of both types of record
• Be able to categorize and validate GxP/GMP computer systems
• Understand the importance of training and quality culture in avoiding a regulatory enforcement action
• Get on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance
• Learn how to govern data
• Learn how to respond to data integrity observations in inspection reports
• Learn how to prevent, detect and remedy data integrity problems

Areas Covered in the Webinar:

• What is Data Integrity
• Data Integrity Framework
• Data Privacy
• Data Life Cycle
• Regulations: 21 CFR 11, Annex 11, GAMP 5
• IT systems validation
• Data Integrity Risk Assessment
• Change Control
• Electronic Approvals
• Choosing vendors and outsourcing
• Data privacy and protection of subject data
• Quality Assurance and Quality Control
• Monitoring and auditing of data
• Audit trails, access controls and user permissions
• Handling Errors and Corrections
• Storage and Transfer of Data

Who Will Benefit:

• Quality Assurance
• Documentation Managers
• Records Managers
• Document Control
• Compliance
• Medical Affairs
• IT Professionals
• Data Managers
• Safety Managers
• Systems Administrators
• Databases Administrators
• Regulatory Affairs
• Laboratory managers and supervisors
• Production managers and supervisors
• Auditors

From the following Industries:

• Pharmaceutical
• Medical Devices
• Food and Beverages
• Cosmetics
• Contract laboratories
• Clinical research organizations
• Suppliers and service providers of instruments and computer systems

Free Materials:

• Presentation
Instructor Profile:



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.

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