- 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 21 CFR 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
Day 1 Schedule
Day 1 (8am to 5pm; 0.5 registration, 1.0 lunch, 0.5 (2-15min) breaks, 7.0 class = 9.0)
8:00am to 8:30am registration
8:30am class starts
Lecture 1:
Introduction to the FDA (1:30) {1:30}- 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 (4:00) {5:30}- 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 (0:30) {6:30}- The Who, What, Where, When, and Why of CSV
Lecture 4:
The Validation Team (0:30) {7:00}- How to select team members
- How to facilitate a validation project
Day 2 Schedule
Day 2 (9am to 3:30pm; 1.0 lunch, 0.5 (2-15min) breaks, 5.00 class = 6.5)
Lecture 5:
Ten-Step Process for COTS Risk-Based Computer System Validation (1:00) {1:00}- 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 – http://www.pda.org, 2006).
Lecture 6:
How to Write Requirements and Specifications (0:30) {1:30}- Workshop for writing requirements and then expanding them for specifications
Lecture 7:
How to Conduct a Hazard Analysis/Risk Assessment-Exercise (0:30) {2:00}- Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
Lecture 8:
Software Testing (1:00) {3:00}- Reduce testing by writing test cases that trace to elements of risk management.
- How to write efficient test cases
Lecture 9:
System Change Control (0:30) {3:30}- How to manage a validated system with minimal documentation
Lecture 10:
Purchasing COTS Software (0:30) {4:00}- How to purchase COTS software and evaluate software vendors.
Lecture 11:
Cost Reduction Without Increasing Regulatory or Business Risk (1:00) {5:00}- How to save money
- How to increase quality
- How to increase compliance with less documentation
Carolyn Troiano
Consultant, BrainStorm Central Consulting
Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
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