Seminar Assuring Data Integrity in the Life Science industry

Medical

world compliance seminars
Location: Boston Apr 21 - 22, 2016 at Boston MA
$795 for 2 day workshop
In the face of aggressive audits by regulatory agencies, life sciences companies continue to face unprecedented compliance challenges in ensuring data integrity. Such audits are unlikely to abate anytime soon. On the contrary, the agencies are hiring very highly literate computer experts to audit and aggressively pursue data integrity issues during audits. In the past four years, highly visible audits and investigations coupled with aggressive prosecution have resulted in significant financial judgments against even the most leading life sciences companies. Consequently, companies can no longer ignore the heightened challenges of ensuring data integrity in their enterprise. Business expediency requires them to train their personnel in understanding data integrity so that they can effortlessly identify and remediate potential data integrity before the auditors do so.
This interactive two-day workshop planned by WCS provides attendees the opportunity to interact with a Data Integrity Subject Matter Expert. Filled with numerous case studies from companies across the world, this workshop provides participants with the knowledge, approaches and techniques to effectively establish, monitor, control and assure the integrity of paper based and electronic data. It is designed for novice as well as experienced personnel from QA, IT, manufacturing, regulatory and validation groups. It should also be of special interest to mid-level as well as senior level management personnel.
Addressed will be case studies, inspection approaches, past issuance of 483s and warning letters pertaining to data integrity. Take back to your work, samples of Data Integrity related SOPs such as corporate wide Data Integrity policy, data integrity risk management, data integrity validation etc
Areas Covered
What is Data integrity
Data Life Cycle design and controls
Attributes of Data Integrity and how they map to predicate rules
How do you know that you have a Data Integrity problem in your company
Elements of a Data Integrity Assurance program
Roles and responsibilities of different groups in ensuring data integrity
What data integrity SOPs do auditors expect to see during audits
Validating Data Integrity
Related Jobs or Careers: Pharmaceutical industry / Medical device industry / Healthcare industry personnel Developers of software for use in Life Scie
This is primarily ilt training
Course Level:intermediate
Duration:2 days
Training Presented in:English
Training Provided by world compliance seminars
Seminar Assuring Data Integrity in the Life Science industry
Learning Objectives
What are the recent regulatory changes for Data Integrity
What should be the management structure for DI accountability
What are the documentation requirements for Data integrity
What factors to consider before establishing a DI plan
How does CFR 21 Part 11 and Annex 11 requirements translate to data integrity requirements
What are the success factors for a DI program
How is DI validated
About The Training Provider: world compliance seminars
world compliance seminars - WCS Consulting Inc. we conduct in person seminars on quality and regulatory topics and has the top industry experts and consultants in the country. Our onsite trainers and consultants are dedicated to providing you with the most useful and up-to-date information available at the most reasonable price. Our trainers and consultants will exceed your expectations by providing top quality training...
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