Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Advertising

Press Release

Two Day Workshop: Current Issues in Assuring Data Integrity in Life Sciences (Boston, United States - October 4th-5th, 2017) - Research and Markets

Research and Markets
Posted on: 30 Aug 17

The "Current Issues in Assuring Data Integrity in Life Sciences" conference has been added to Research and Markets' offering.

This training focuses on implementing Data Integrity programs using the least burdensome approach, a technique that regulators themselves employ to conduct their audits. The training also addresses the evolving concepts and guidance from regulatory agencies such as the recently issued industry guidance on Part 11 for Clinical Investigations among many others.

Addressed will be case studies, inspection approaches, and trends in the issuance of data integrity 483s and warning letters in the recent past. Take back to your work, samples of Data Integrity related directives and SOPs such as Data Integrity Policy, Maintenance of Electronic Records directive and many more that are required to establish a data integrity infrastructure in your company.

This workshop is for novices as well as experienced personnel from QA, IT, manufacturing, regulatory and validation groups. It addresses data integrity issues in all life science industry sectors where data is required to fulfill regulatory requirements. These sectors include medical devices, biologics manufacturing, quality control laboratories, clinical trials, blood establishments, compounding pharmacies etc.

Areas Covered:

  • What is Data integrity
  • Data Life Cycle design and controls
  • 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

Learning Objectives:

  • Some advanced Data Integrity topics include:
  • Data Integrity triad
  • Data Integrity Maturity Model
  • Developing critical thinking skills
  • Data Integrity Audit trends

Who Should Attend:

  • Pharmaceutical industry / Medical device industry / Healthcare industry personnel
  • Developers of software for use in Life Sciences industry
  • Validation service providers, IT service providers
  • Manufacturing personnel, Manufacturing Automation system vendors and system integrators
  • Regulatory Affairs group, Quality Unit
  • Laboratory personnel
  • Users of Cloud
  • Clinical Trial Sponsors

For more information about this conference visit https://www.researchandmarkets.com/research/6sc4pl/current_issues_in

View source version on businesswire.com: http://www.businesswire.com/news/home/20170830005568/en/

Business Wire
www.businesswire.com

Last updated on: 30/08/2017

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.