Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance

Teachers
Judy Carmody, Ph.D.
Category:
IT & Data Integrity for Pharma/ On-Demand Courses/ Regulatory & Compliance/
Clear
Duration: 90 minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Software-driven data collection systems are now ubiquitous in preclinical, clinical, and manufacturing settings in the life sciences.  The data collected, processed, and maintained by these systems are used by regulatory agencies to make decisions regarding approvals.  Therefore, this data – and the systems used to collect it – must meet regulatory requirements when submitted for review to an approving agency.  Electronic data has many advantages over paper but it also creates new challenges in assuring accuracy and reliability.  Because of these risks, the number of FDA Form 483 observations related to electronic data integrity is on the rise.

This training will underline the meaning of electronic data integrity and how to comply throughout the data lifecycle (i.e., creation to use to archive to deletion).  By attending, participants will be able to orchestrate data governance and computer systems validation strategies that position organizations for compliance.

LEARNING OBJECTIVES
  1. Understanding data integrity and the data lifecycle within a GxP environment
  2. Applying current regulations and industry standards to electronic data
  3. Identifying the most common issues observed with electronic data integrity compliance, including example warning letters
  4. Understanding the role of robust data governance in achieving compliance
  5. Developing software validation strategies that increase data integrity compliance

Who Should Attend

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

WHO SHOULD ATTEND

This course will be of benefit to anyone involved the generation, use, and maintenance of regulated electronic data within a GxP environment.  Content is highly-relevant for those in Laboratory Data Systems, Quality Assurance, Regulatory Affairs, Validation, IT, and other job functions responsible for the generation, use, and maintenance of electronic data.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Judy Carmody, Ph.D.
Expertise driving vision in operations, QA, control, systems, and validation/analytical development within global organizations.