Data Integrity and Privacy for FDA Regulated Industries

Eleonora Babayants
Instructor:
Eleonora Babayants
Date:
Tuesday, July 14, 2020
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 503210

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
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Overview:

Effective and compliant data management is critical to organizations in the regulated industries. Data integrity is defined as the extent to which all data is complete, consistent, accurate, trustworthy, and reliable throughout the data lifecycle, from its creation to archiving and its eventual destruction.

Regulatory agencies, as well as the life sciences industry, rely on data to ensure patient’s rights and safety and the scientific value of clinical studies.

Data Integrity and related regulations ensure that computer systems are implemented to a certain standard of quality and trustworthiness.

Data privacy is also very important and is heavily regulated. It is absolutely necessary to maintain data integrity and privacy in order to be compliant with FDA regulations.

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 webinar the attendees will have knowledge of principles of data Integrity and data privacy based on FDA regulations.

Areas Covered in the Session:

  • 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

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

Who Will Benefit:
  • Quality Assurance
  • Documentation Management
  • Document Control
  • Compliance


Speaker Profile
Eleonora Babayants is a Galaxy Consulting Founder and President, She is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management.

Eleonora's past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs.

She led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users' requirements.

She wrote technical documents and created documents templates. Eleonora's experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.


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