FDA CFR Part 11, ICH GCP, GMP, (CSV)- What's the hype all about?
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- Опубліковано 5 жов 2019
- Computer Systems Validation (CSV) has been an FDA requirement under ICH GCP, GMP and 21 CFR Part 11 since more than 20 years. Nevertheless, companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation. Validation professionals know the principles but have problems with implementation, especially with the development of protocols. This seminar gives you a good understanding of FDA requirements for computer system validation and provides steps for cost-effective implementation.
Computer System Validation (CSV) is required by the FDA and many other international regulatory agencies. However, when you are new to CSV, it is often unclear which systems need validation, exactly what is meant by validation, and what steps to take to implement a computer system validation program.
In this short and free webinar by VISTA InfoSec and hosted by our sought after speaker - Narendra Sahoo, you will learn why regulatory agencies, such as the FDA, require computer system validation, as well as the consequences of failing to validate your systems.
You will discover which of your systems require validation-and which do not. This includes custom-built applications, off-the-shelf packages, and spreadsheets. This webinar also provides you with a walk through the process of computer system validation and its key deliverables.
Chapters
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3:35 Introduction to 21 CFR Part 11
15:34 Why is Part 11 required?
17:02 What is an electronic record
18:03 21 CFR Part 11 - 10 Steps to Compliance
18:51 Requirement 1 - System Documentation / Validation - What is Computer Validation?
26:08 Requirement 2 - Ability to generate accurate and complete copies of records
27:48 Requirement 3 - Protect and easily retrieve records through their retention period
29:35 Requirement 4 - Ability to discern changes to records through the use of audit trails
30:49 Requirement 5 - Proper security controls
32:25 Requirement 6 - Trained and Qualified Individuals
32:58 Requirement 7 - SOPs
33:29 Requirement 8 - Encryption
34:12 Requirement 9 - e-Signature components and controls General Requirements
36:58 Requirement 10 - Signature linking to records Standard acrobat embedded signature
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Helpful!!
Glad it was helpful!.. Appreciate your comment
Awesome high level information on 21 CFR Part 11!
Glad it was helpful!.. Appreciate your comment
Pls describe the validation approach for gamp 5 software
Nice information
So nice of you
Nicely explained
Thank you
Who was this webinar originally provided for? Apparently it was given live and there are people asking questions but there’s no indication as to what company this was presented to or if it was presented online in general. I ask because I have an interest in attending live webinars as opposed to pre-recorded webinars.
Hello, this is part of our live online webinars that we conduct. These webinars are free and open for all to attend. Ofcourse the live QnA is one of the key reasons many choose to attend.
Do drop me a line on info@vistainfosec.com and would add you to our listing for sending out the webinar invites.
Thank you for your comment.