09:00 AM - 10:00 AM
Introduction to the FDA

- How the regulations help your company to be successful
- Which data and systems are subject to Part 11

10:00 AM - 02:00 PM
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

02:00 PM - 02:30 PM
The Five Keys to COTS Computer System Validation

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

02:30 PM - 03:00 PM
The Validation Team

- How to select team members
- How to facilitate a validation project

09:00 AM - 10:30 AM
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 a 10 Minute break

10:30 AM - 11:00 AM
How to Write Requirements and Specifications

- Workshop for writing requirements and then expanding them for specifications

11:00 AM - 12:00 PM
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

12:00 PM - 01:15 PM
Software Testing
Location: Auditorium

- Reduce testing by writing test cases that trace to elements of risk management.
- How to write efficient test cases

* Includes a 40 Minute Lunch Break

01:15 PM - 02:00 PM
How to write a Data Privacy Statement

- How to meet the requirements of the EU GDPR

* Includes a 10 minute break

02:00 PM - 02:30 PM
Purchasing COTS Software

- How to purchase COTS software and evaluate software vendors

02:30 PM - 03:00 PM
Cost Reduction Without Increasing Regulatory or Business Risk

- How to save money
- How to increase quality
- How to increase compliance with less documentation