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Compliance Training Panel.

Compliance Training Panel provides Quality trainings through their world class platform which enables the clients to discuss with industry experts and to gain related information.

Compliance Training Panel has been established by professionals in the field of Quality, Compliance Auditing and Health Care, Education & Finance with an objective to create an ecosystem that will deliver quality training's on compliance of various regulatory and legal requirements.

We are a US based organization specializing in online trainings in the form of Webinars and Seminars.


Data Governance for Computer Systems Regulated by FDA
Compliance Training Panel (CTP) - Scheduled Date and Time    Compliance Training Panel (CTP) - Timer
Description :
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a step further, we are now looking at ways to ensure the data that resides on these systems is also managed in a compliant manner and one that will provide the best results for operations at the lowest cost.
Objective :
After attending this course, you will understand data governance as a quality control discipline for assessing, managing, using, improving, monitoring, maintaining, and protecting organizational information. It is a system of decision rights and accountabilities for information-related processes, executed according to agreed-upon models which describe who can take what actions with what information, and when, under what circumstances, and, finally, using what methods.
Why You Should Attend :
Upon completion of this session, attendees will have an understanding of how to:
  • Tie data governance activities and investments to corporate drivers, strategies and compliance
  • Establish data governance program objectives, decision-making organizational structures and assigned roles and responsibilities that fit within the organizational culture
  • Understand the role of data owners vs. data stewards
  • Understand the criticality of data identity, trust, security, integrity, accessibility, reliability and consistency
  • Design data governance processes that encompass people, processes and technology
  • Understand the policies and procedures necessary to support the data governance framework
The attendees will have a good grasp of how to leverage the best practices across all systems by creating a standardized program for data governance.
Areas Covered in the Session :
This webinar will cover the following key areas:
  • Establishing a data governance framework and program for data that is collected, analyzed, stored or reported using a computer system subject to FDA regulations
  • How to use a data governance framework as a logical structure for classifying, organizing and communicating complex activities involved in making decisions about and taking action on enterprise data
  • How to ensure that data governed by FDA adheres to the principles of Computer System Validation (CSV), System Development Life Cycle (SDLC) Methodology, and Electronic Records and Signatures (21 CFR Part 11), as applicable
  • How to leverage industry best practices in developing an overall data governance framework and program
  • How to ensure your data
  • Q&A
Who Will Benefit:
Within FDA-regulated companies, people in the following roles will benefit from this presentation:
  • Computer System Validation Specialists
  • Information Technology Professionals
  • Data Analysts and Managers
  • Automation Analysts and Managers
  • QC/QA Analysts and Managers
  • Laboratory Analysts and Managers
  • Manufacturing Analysts and Supervisors
  • Supply Chain Managers and Analysts
  • Compliance and Audit Managers
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • Vendors of Computer Systems
  • System Implementation, Integration and Validation Specialists
Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of product must understand and conform to FDA requirements for data quality and integrity. Finally, anyone who is acting as a consultant or contractor to a company in an FDA-regulated industry should attend to ensure they are able to bring the most current knowledge and expertise to their assignment.
About Speaker:
Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
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