Evolving Regulatory Expectations for Data Integrity in GMP laboratory

Duration: 90 Minutes
Data Integrity has become an increasing concern for Regulatory Agencies worldwide. The majority of the laboratory related warning letters in 2015 focused on this area. A review of Data Integrity failures indicates that the root causes include employee errors and lack of adequate data reviews, inadequate laboratory instrument software system, and configuration problems associated with laboratory electronic data and malfeasance by employees. The FDA issued a draft guidance in April 2016 on Data Integrity which when issued in final form will have wide implications on how raw data, both electronic and paper, is to be generated, reviewed and archived. This webinar addresses the key elements of regulatory expectations for Data Integrity in the GMP Laboratory.
Data Integrity in GMP laboratory
Instructor: Nanda Subbarao
Product ID: 501608
Objectives of the Presentation
  • What are the new and evolving regulatory expectations
  • What are the consequences of not meeting regulatory expectations for Data Integrity
  • Common pitfalls observed during generation, review and archiving data
  • How are the regulatory requirements evolving for electronic data generated in the laboratory
  • What are the new auditing requirements for Data Integrity
  • What are the systems required to support Data Integrity
Why Should you Attend
Attendees will obtain an understanding of the Regulatory expectations for Data Integrity. The information provided at the webinar will enable the attendees to review practices at their own site, identify gaps relative to current regulatory expectations and utilize the advice provided during the webinar to address the identified issues.

Who can Benefit
  • IT Department personnel responsible for lab data
  • QC chemists, supervisors and managers
  • R&D chemists, supervisors and managers
  • QA Managers and personnel
  • Regulatory Affairs personnel
Topic Background
The majority of the laboratory related warning letters in 2015 focused on this area. Lab data is increasingly the main focus of FDA inspections. The FDA issued a draft guidance in April 2016 on Data Integrity which when issued in final form will have wide implications on how raw data, both electronic and paper, is to be generated, reviewed and archived.
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. Subbarao is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products ranging from conventional drugs to well characterized proteins and vaccines, from pre-clinical phase to commercial phases. She has been involved several times over her career in projects to setup or upgrade cGMP/GLP complaint Quality Systems for laboratory and stability programs for products during development and in commercial phase. She participates in the AAPS Stability Focus Group Steering Committee.


View More