Ensuring Data Integrity through mapping DI, Part 11 and Annex 11

Duration: 90 Minutes
CFR 21 Part 11 and Annex 11 regulations were introduced to regulate the increasing use of computers in the biopharmaceutical industry. These regulations addressed the need for data's trustworthiness or integrity. While regulatory agencies provided the biopharmaceutical industry time to adapt their policies, procedures and practices to these regulations, they have recently started to enforce them routinely. Knowledge of the specifics of these regulations are essential to ensuring data integrity issues that have been addressed to the satisfaction of the regulators. Besides addressing the specifics of these regulations, the webinar will also help you understand the correlation between the attributes of data integrity and these regulations. This understanding is essential for the uncovering of potential DI problems in a company.
Data Security Best Practices
Instructor: Chinmoy Roy
Product ID: 500687

It is critical that you demonstrate you have effective control of your data and its integrity through the establishment of sound data policies and procedures. Correctly mapping Data integrity attributes to Part 11/Annex 11 requirements is the first step in a series of procedures to ensure data integrity. This webinar will discuss the attributes of Data integrity; the specifics of Part 11/Annex 11 and then cross map these. Since this is a pre requisite for future webinars on Data integrity, the map will be used as the basis of those future webinars.

Why Should you Attend:
This webinar demonstrates mapping techniques between data integrity attributes and CFR 21 Part 11 and Annex 11. This map forms the basis for validation for ensuring data integrity and is a component of the validation registry of your company.

Objectives of the Presentation:
At the end of the webinar, participants will learn about:
  • Data Integrity attributes explained
  • Part 11 and Annex 11 specifics
  • Similarities and dissimilarities between Part 11 and Annex 11
  • Mapping Data Integrity attributes to Part 11
  • Mapping Data Integrity attributes to Annex 11
Who can Benefit:
  • QA
  • QC
  • Engineering
  • IT personnel
  • Manufacturing
  • Validation consultants.
$300
Recorded Session for one participant
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  • 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:
Chinmoy Roy has 40+ years of experience in the US Life sciences industry. He is an internationally recognized Subject Matter Expert (SME) in Data Integrity, CSV, CFR 21 Part 11, Annex 11 and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu's annual conference for Asia Pacific, etc. He has worked at or been a consultant for leading US companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. He has been on Data Integrity discussion panels with FDA inspectors. He travels worldwide to conduct CSV and Data Integrity training.

He was one of the early implementers of the world's largest fully paperless manufacturing automation IT system that conforms to 21CFR Part 11 and Data Integrity. He led a team of over 40 engineers and Validators to design the system and obtain ‘fit for use’ certification in 1999. His pioneering efforts in implementing that system while employed by Genentech, was a precursor to FDA's issuance of Part 11's Scope and Application guidance in 2003.
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