subject: Compliance For 21 Cfr Part 11, Reducing Costs Using Risk-based Computer System Validation [print this page] Why Should You Attend: Why Should You Attend:
This interactive one-day virtual seminar provides proven techniques for reducing costs associated with implementing, using and maintaining computer systems in regulated environments. Nearly every computerized system utilized in laboratory, clinical, manufacturing and the quality process has to be validated. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. Explore methods to decrease resource requirements, and make documentation more manageable and understandable. This often results in a savings of two-thirds the costs. Additionally, this course will help companies increase compliance with the new 21 CFR Part 11 regulations and demonstrate how to use risk management to improve system performance and promote process improvement.
How It Works:
The webinar has a series of modules, each about 60 minutes long. Our speaker, Mr. David Nettleton, will deliver the modules using PowerPoint slides. At the end of each module, there is an interactive portion where participants can ask questions and clarify information. The modules also include multiple-choice questions to help participants assure they understand the material. Some of the modules contain exercises for participants that help illustrate the points covered and further increase learning. The interactive portion includes a discussion of the questions and exercises.
Areas Covered in the Seminar:
1. Introduction to the FDA
Interactive discussion that builds the foundation for electronic records:
- Why the FDA regulates.
- How the regulations work together.
- Introduction to Part 11.
- Predicate rules.
- FDA and international standards.
- GAMP.
2. 21 CFR Part 11 - Compliance for Electronic Records and Signatures
Interactive discussion that details the regulation and how it applies to computerized systems. What makes this session unique is the understanding of how the concepts of Part 11 affect industry standards related to computer systems.
- Which data and systems are subject to Part 11.
- What Part 11 means, not just what it says.
- Avoid 483 and warning letters.
- Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
- Ensure data integrity and protect intellectual property.
- Current computer system industry standards for security, data transfer, and audit trails.
- Digital pens, electronic signatures, 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.
3. The Five Keys to COTS Computer System Validation
Interactive discussion of the fundamentals of user validation for Commercial Off-The-Shelf (COTS) software as required by 21 CFR Part 11. What makes this session unique is the complexity of the topic is restated in terms everyone can understand.
- Apply the Who, What, Where, When, and Why of risk-based computer system validation.
- Understand the real life common errors and how to avoid them.
- Reduce staff resources, documentation, and project timelines.
- Real life examples to ensure success.
- Recommendations for performing efficient validation projects.
- How to use resources effectively.
- Increase compliance while lowering costs.
4. Selecting a Validation Team That Is Effective
Interactive discussion that describes how to assemble a validation team for maximum productivity and most efficient use of resources.
- Members.
- Team characteristics.
- How to facilitate and how to lead.
- How to get the right people to work together so validation is efficient and takes only one-third the time.
5. How to Write Requirements and Specifications
Workshop exercises that teach how to write a requirement and then build upon it to write a specification. What makes this session unique is the hands on experience of authoring as a team.
- How requirements and specification differ.
- What they have in common.
- How to author as a team.
- Workshop exercises.
6. Software Testing How to Reduce Time and Costs
Interactive discussion that details the role of testing within the risk-based validation approach in order to reduce time and costs while ensuring process controls.
- Testing concepts and tools for efficient testing.
- Static vs. dynamic test methods.
- How to perform and document testing.
- How to track bugs and issues during testing.
- How to use testing to verify system acceptance without testing everything.
- Proven techniques for reducing testing time and documentation while improving defect detection.
- How to efficiently write and execute test cases.
- How to develop the testing protocol.
- How to reduce testing to one-third the time.
- It concludes with an array of testing strategies that improve quality and reduce testing time.
Who Will Benefit:
- People that use computer systems in mission critical applications
- Also ideal for software developers and software vendors
- Participants learn valuable skills that make them more efficient users of any type of computer system
- Participants should have some experience in a GxP environment
Instructor Profile:
David Nettleton, is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer systemvalidation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 196 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps (Davis Horwood International and PDA - www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project.
