Every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated regularly in order to confirm the efficiency. The two day seminar will help in understanding the techniques to reduce costs associated with implementing, using, and maintaining computer systems in regulated environments. The course will focus on how to decrease software implementation time and costs by using a risk based approach to system validation.
The instructor will be discussing on the latest computer system industry standards for data security, data transfer, and audit trails. Attendees will also get knowledge on the recent FDA inspection trends and how to streamline SOP authoring, revision, review, and approval.
The seminar is designed to provide a detailed overview on implementing a computer system validation to gain maximum productivity and reduce costs by as much as two thirds. Following are the main objectives of the two day interactive seminar:
• How to make use of temporary workers and outsourcing to promote growth and reduce costs.
• Implement control methods that allow quick and safe system evolution.
• Minimize the validation documentation to reduce costs without increasing regulatory or business risk.
• Protect intellectual property and keep electronic records safe.
• Write efficient test cases that trace to elements of risk management.
Important contents covered in the seminar are:
• 21 CFR Part 11 - Compliance for Electronic Records and Signatures
o Avoid 483 and Warning Letters
o Three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
o Ensure data integrity, security, and protect intellectual property.
o SOPs required for the IT infrastructure.
• HIPAA Compliance for Electronic Records
o How part 11 and HIPAA interrelated
• The Five Keys to COTS Computer System Validation
• Ten-Step Process for COTS Computer System Validation
• How to Conduct a Hazard Analysis/Risk Assessment-Exercise
• How to write efficient test cases to reduce software testing
• How to manage a validated system with minimal documentation
• Cost Reduction Without Increasing Regulatory or Business Risk
Who will benefit
This course will be beneficial for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. This can be valuable to the following personnel who use computer system to do their job functions.
- Regulatory Affairs
- QA/ QC
- Software Managers
- Project Managers
- Software vendors and suppliers