21 CFR Part 11 Complying with: Step by Step

Duration: 75 Minutes
There is an increasing use of computers and electronic data in the pharmaceutical industry. Consequently, management of electronic records and data continues to be a concern of the regulators. CFR 21 Part 11 regulations were enacted in 1997 to address those concerns.
Part 11 Compliance Strategy
Instructor: Chinmoy Roy
Product ID: 500089
The key objective of this webinar is to use Part 11 regulation as an input to define an "easy-to-implement" framework for Part 11 compliance. Through easy-to-use steps for identifying electronic records that need to meet Part 11 compliance, the framework will provide the guidance to avoid Part 11 compliance traps. For pharmaceutical drug manufacturers, this framework will not only reduce compliance costs, but it will also reduce vulnerability to audit failures. For IT organizations and software vendors, this framework helps to proactively audit software development and implementation processes on an ongoing basis to identify and correct any systemic issues to lower the cost of compliance.

Why Should you Attend:
To meet competitive pressures, pharmaceutical companies are migrating their systems from a paper based to an electronic one. To meet this industry trend and the desire to derive the evolutionary benefits of science, regulatory agencies have issued regulations to meet the challenges that arise from capturing and maintaining electronic data and records. They have also increased their vigilance of the industry through increased audits and citations.

This webinar addresses the "common language of issues pertaining to the authenticity and integrity of electronic data” and a documentation strategy required to maintain a defensible Part 11 compliance strategy to meet compliance requirements.

Objectives of the Presentation:
Topics covered in this webinar include:
  • Worksheet to identify elements that need to comply with Part 11
  • How to implement a risk based approach to identify elements that need to be Validated
  • What are the Part 11 classifications for validating a system for Part 11 compliance
  • A Part 11 audit questionnaire for vendor products
  • Case studies: spreadsheets, HPLC, LIMS
  • Some Part 11 Warning Letters and 483s
Who can Benefit:
  • Device Manufacturers
  • Equipment Manufacturers
  • IT Personnel
  • Software Engineers
  • Engineering Designers
  • Risk Managers and Others Performing Risk Management Activities
  • Those involved in process improvement
  • QA
  • QC
  • Manufacturing
  • Validation Consultants
$375
Recorded Session for one participant
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Recorded Session - How it works
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  • 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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