Bulletproofing your cGXP Documentation from Audit Citations

Duration: 60 Minutes
Regulators consider documentation to be a critical entity. Consequently, they always audit documentation systems and it is rare to find audits where 483s for poor documentation have not been issued.
cGXP Documentation
Instructor: Chinmoy Roy
Product ID: 500059
By attending this webinar, you will become familiar with what attributes contribute to good document development, the complexities and challenges posed by hybrid documentation systems and steps you absolutely need to take to ensure that your documentation system is bullet proof.

Developing documentation to meet regulatory approval involves activities that record information and data either electronically or on paper. These documents should be developed such that they promote the easy dissemination of the information/data instead of confusing the operations.

Why Should you Attend:
The ability to write clear and concise documents is an essential skill required of those working in the Life Sciences industry. This course is ideal for all people who are required to create, complete and/or review documents in the Life Sciences industry.

Objectives of the Presentation:
At the end of the webinar, participants will:
  • Become aware of document types audited
  • Have exposure to examples of Quality attributes of documents
  • Understand the regulatory requirements for electronic documents
  • Become aware of the requirements for maintaining paper documents
  • Become familiar with SOP requirements that auditors look for
  • Review some Good Documentation Practices related 483s and WL
Who can Benefit:
  • Project Managers
  • IT Engineers
  • Design Engineers
  • Documentation System managers
  • Consultants
  • QA Who review and approve raw data
  • Regulatory Affairs Submission Personnel
Live Session - How it works
  • We will send Username and password 24 hours prior to webinar at your email address.
  • Webinar presentation handouts will be shared in pdf format, a day before live presentation.
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  • Clear out your queries through interactive Q&A chat boxes with the speaker.
  • We need to know your experience, so please don't skip to provide us with your overall presentation feedback.
  • Get certification of attendance.
Recorded Session - How it works
  • Once you purchase a webinar you will receive username and password at your email address.
  • Use the login details to view recorded webinars.
  • Presentation handouts will also be shared in pdf format.
  • Access to the recording is valid only till 6 months starting from the date of purchase.
  • Get certification of attendance.
$375
Recorded Session for one participant
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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:
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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