HEALTHCARE 2020 - 6-Hour Virtual Seminar on IT Systems Validation for FDA Regulated Industries

Website https://www.globalcompliancepanel.com/virtual-seminar/--10427LIVE?channel=ourglocal-May_2020_SEO | Edit Freely

Category HEALTHCARE 2020

Deadline: May 27, 2020 | Date: May 27, 2020

Venue/Country: Online Event, U.S.A

Updated: 2020-03-13 21:15:33 (GMT+9)

Call For Papers - CFP

We will walk through the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer systems, and will also discuss 21 CFR Part 11, European equivalent Annex 11, GAMP 5 which deal with controlling risk and managing computer systems over their life cycle including validation. We will discuss what is needed to prepare for an FDA inspection of computer systems and data.

Attendees will:

Learn how to identify “GxP” Systems

Learn about the System Development Life Cycle (SDLC) approach to validation

Learn best practices for documenting IT system validation efforts, including requirements, design, development, testing and operational maintenance procedures

Understand how to maintain a system in a validated state through the system’s entire life cycle

Learn about the policies and procedures needed to support your validation process

Learn how to best prepare for an FDA inspection or audit

Lean clinical trial related IT systems validation

Why you should attend

Software validation is not just a regulatory necessity. It is fast becoming a necessity for the device industry's increasingly software-controlled environments.

Many companies struggle with understanding how to avoid major mistakes and inspection risk when validating software to FDA standards. This webinar will review the validation planning process with emphasis on avoiding common pitfalls. The attendee should leave the presentation confident in their ability to improve the level of validation success.

If data becomes invalid, based on improperly validating and maintaining the system that houses it in a validated state, the work related to the data would need to be repeated. This could result in a devastating loss to a company.

Learn how to develop the appropriate IT systems validation strategy. Understand how to effectively document the process of IT systems validation, and maintain current information about the various systems in your organization. We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation.

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