This interactive one-day seminar details how to reduce costs associated with implementing, using, and maintaining computer systems in regulated environments. Nearly every computerized system used in laboratory, clinical, manufacturing and the quality process has to be validated. Participants will learn the latest techniques for complying with 21 CFR Part 11 that greatly reduce software validation project time. Methods for decreasing resource requirements, and making documentation more manageable and understandable often result in a savings of two-thirds the costs. Additionally, this course will help companies increase productivity and demonstrate how to use risk management promote process improvement.
Agenda: Module 1: Introduction to the FDA
Module 2: 21 CFR Part 11 - Compliance for Electronic Records and Signatures
Module 3: The Five Keys to COTS Computer System Validation
Module 4: Selecting a Validation Team That Is Effective
Module 5: How to Write Requirements and Specifications
Module 6: Software Testing How to Reduce Time and Costs
Module 7: Cost Reduction Without Increasing Regulatory or Business Risk
Q&ADuration (All in EST): 10:00-11:00 - Introduction to the FDA
11:00-1:00 - 21 CFR Part 11 - Compliance for Electronic Records and Signatures
1:00-2:00 - Lunch hour
2:00-2:30 - The Five Keys to COTS Computer System Validation
2:30-2:45 - Selecting a Validation Team That Is Effective
2:45-3:00 - How to Write Requirements and Specifications
3:00-3:30 - Software Testing How to Reduce Time and Costs
3:30-3:45 - Afternoon break
3:45-4:45 - Cost Reduction Without Increasing Regulatory or Business Risk
4:45-5:00 - Q&A
Who Will Benefit: - Regulatory, quality, clinical, laboratory, and IT staff working in the health care, clinical trial, laboratory, manufacturing, pharmaceutical, biotechnical, and medical device markets.
- Desirable for software vendors, and software developers.
