NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.
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
2. 21 CFR Part 11 - Compliance for Electronic Records and Signatures
3. The Five Keys to COTS Computer System Validation
4. Selecting a Validation Team That Is Effective
5. How to Write Requirements and Specifications
6. Software Testing – How to Reduce Time and Costs
7. Cost Reduction Without Increasing Regulatory or Business Risk
Who Will Benefit:
- People that use computer systems in mission critical applications
- Ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, laboratory, manufacturing, pharmaceutical, biotechnical, and medical device markets
- 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
