21 CFR Part 11 compliance for software validation, data integrity and SaaS/Cloud

21 CFR Part 11 compliance for software validation, data integrity and SaaS/Cloud

Seminar Educational

Tue, Oct 30, 2018, 09:00 AM -  Wed, Oct 31, 2018, 06:00 PM


Contact details
Support Team
Organiser : S2M Trainings
Location details
Mariyyman Nagar,Greater Indra Nagar
The Leela Mumbai Andheri Kurla Road, Sahar, Andheri East
Mumbai - Maharashtra
About us


·         This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.

·         Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.

·         The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.

·         Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.

·         This seminar will help you understand the specific requirements associated with local and SaaS/cloud hosting solutions.

·         Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated.

·         Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.

·         Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.

·         This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

Course Objectives

·         Understand what is expected in Part 11 and Annex 11 inspections

·         Avoid 483 and Warning Letters

·         Learn how to buy COTS software and qualify vendors.

·         Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds

·         Requirements for local, SaaS, and cloud hosting

·         How to select resources and manage validation projects

·         "Right size" change control methods that allows quick and safe system evolution

·         Minimize the validation documentation to reduce costs without increasing regulatory or business risk

·         Write test cases that trace to elements of risk management

·         Protect intellectual property and keep electronic records safe

Who Will Benefit

·         QA, IT, management

·         all GxP system users


Day 1 Schedule

Lecture 1: Introduction to the FDA

·         How the regulations help your company to be successful

·         Which data and systems are subject to Part 11

Lecture 2: 21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures

·         What Part 11 means to you, not just what it says in the regulations

·         Avoid 483 and Warning Letters

·         Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation

·         How SaaS/cloud computing changes qualification and validation

·         Ensure data integrity, security, and protect intellectual property

·         Understand the current computer system industry standards for security, data transfer, and audit trails

·         Electronic signatures, digital pens, and biometric signatures

·         SOPs required for the IT infrastructure

·         Product features to look for when purchasing COTS software

·         Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Lecture 3: The Five Keys to COTS Computer System Validation

·         The Who, What, Where, When, and Why of CSV

Day 2 Schedule

Lecture 1: Ten-Step Process for COTS Risk-Based Computer System Validation

·         Learn which documents the FDA expects to audit.

·         How to use the risk-based validation approach to lower costs.

·         How to link requirements, specifications, risk management, and testing.

·         Document a computer system validation project using easy to understand fill-in-the-blank templates.

·         Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).

Lecture 2: How to Write Requirements and Specifications

·         Workshop for writing requirements and then expanding them for specifications

Lecture 3: How to Conduct a Hazard Analysis/Risk Assessment-Exercise

·         Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.

Lecture 4: Software Testing

·         Reduce testing by writing test cases that trace to elements of risk management.

·         How to write efficient test cases

Lecture 5: System Change Control

·         How to manage a validated system with minimal documentation

Lecture 6: Purchasing COTS Software

·         How to purchase COTS software and evaluate software vendors.

Lecture 7: Cost Reduction Without Increasing Regulatory or Business Risk

·         How to save money

·         How to increase quality

·         How to increase compliance with less documentation


David Nettleton 

Director & FDA Compliance Specialist,

Computer System Validation and FDA Compliance consultant


David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.


Location: Mumbai, India Date: 30 & 31 October 2018 Time: 9:00 AM to 6:00 PM

Venue: The Leela Mumbai Andheri Kurla Road, Sahar, Andheri East, Mariyyman Nagar, Greater Indra Nagar, Andheri East, Mumbai, Maharashtra 400059

Seminar Price Details:

Seminar Fee for One Delegate Price: Rs. 14,000.00

Register for 5 attendees Price: Rs. 42,000.00 Save: Rs. 28,000.00 (40%)

Register for 10 attendees Price: Rs. 77,000.00 Save: Rs. 63,000.000 (45%)

Registration Link: https://www.s2mtrainings.com/seminar/21-cfr-part-11-compliance-for-software-validation,-data-integrity-and-saas/cloud-600002sem


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