2018 Data Integrity Seminar: FDA/EU Requirements and Implementation - 2 Day Event - ResearchAndMarkets.com

DUBLIN--()--The "2018 Data Integrity Seminar : FDA/EU Requirements and Implementation" training has been added to ResearchAndMarkets.com's offering.

The training will address case studies, inspection approaches and trends. Take back to your work, samples of Data Integrity related directives and SOPs. This workshop is for novices as well as experienced personnel from QA, IT, manufacturing, regulatory and validation groups.

Data Integrity audits project a moving goal post. Issues that were top warning letter vote getters have made way for newer ones to include Cybersecurity etc. Our Data Integrity courses which are offered around the world are renowned for addressing such evolving trends. Consequently, they have attracted record attendances. Attendee feedback suggests the uniqueness of our offerings. Particularly significant is the feedback from those who attended similar courses offered by other companies.

Chinmoy Roy, our course instructor, is one of the world's first to design, implement and obtain fit for use certification for the world's largest paperless biologics manufacturing facility in the late 1990s. He is a practicing Data Integrity auditor. Former FDA inspectors include him on their 3rd party and mock audit teams. He also continues to provide consulting services in the design and implementation of Data Integrity infrastructures to major multinational companies. His lucid and pragmatic presentation style and interaction with the trainees/conference attendees, has earned him the speaker of the year award from attendees of the world's prestigious conference on Data Integrity.

Each attendee will receive 2-Day workshop materials by the speaker. The seminar also includes certificate, complimentary breakfast, lunch & high tea/coffee.

Learning Objectives

  • Data Integrity triad
  • Data Integrity Maturity Model
  • Developing critical thinking skills
  • Data Integrity Audit trends

Key Topics 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

For more information about this training visit https://www.researchandmarkets.com/research/ml5g5f/2018_data?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Pharmaceutical Manufacturing

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Pharmaceutical Manufacturing