OVERVIEW

2-Day Virtual Seminar on Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR is organized by Webinar Compliance and will be held from Feb 17 - 18, 2022.

Scheduled On: February 17 2022 12:00 pm US/Canada (Eastern Time - ET)

Description:
• This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.
• It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation,
• 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.
• 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.
• The instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.
• Participants will learn how to write a Data Privacy Statement to comply with the EU General Data Protection Regulation (GDPR).
• This course benefits anyone that uses computer systems to perform their job functions and is ideal for 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.

Agenda:
DAY 1 : (9 AM – 3 PM)
Introduction to the FDA
• How the regulations help your company to be successful
• Which data and systems are subject to Part 11

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 four primary areas of Part 11 compliance: SOPs, software product features, infrastructure qualification, 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

Includes two 10 minute breaks and a 40 Minute Lunch break

The Five Keys to COTS Computer System Validation
• The Who, What, Where, When, and Why of CSV

The Validation Team
• How to select team members
• How to facilitate a validation project

DAY 2 : (9 AM – 3 PM)
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)

Includes 10 minute Break

How to Write Requirements and Specifications
• Workshop for writing requirements and then expanding them for specifications

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

Software Testing
• Reduce testing by writing test cases that trace to elements of risk management.
• How to write efficient test cases
• Point-of-use aids to compliance

Includes a 40 Minute Lunch Break

How to write a Data Privacy Statement
• How to meet the requirements of the EU GDPR.

Includes 10 minute Break

Purchasing COTS Software
• How to purchase COTS software and evaluate software vendors.

Cost Reduction Without Increasing Regulatory or Business Risk
• How to save money
• How to increase quality
• How to increase compliance with less documentation

Presenter: David Nettleton
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.