Significant amounts of time and effort are spent on validating computer systems. Companies that want efficient, high-quality systems can avoid considerable costs by incorporating CSV capabilities throughout systems development.
David Nettleton will address the latest computer system industry standards for data security, data transfer; audit trails, electronic records and signatures, software validation, and computer system validation related to FDA 21 CFR Part 11, European Annex 11, and HIPAA electronic security regulations for patient medical records.
This course benefits
|
- Understand what is expected in Part 11 and Annex 11 inspections.
- Implement a computer system to gain maximum productivity and reduce cost by as much as two thirds
- Requirements for IT, SaaS, and cloud hosting.
- Quickly cross train workers and see how to make use of temporary workers and outsourcing to promote growth and reduce costs
- "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
|
|
|
|
| |
|
| |
David Nettleton
FDA Compliance Specialist, Author |
| |
David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He has completed more than 225 mission critical laboratory, clinical, and manufacturing software implementation projects.
His services are available to guide companies to create and maintain the systems and procedures required to pass regulatory audits: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.
|
| |
|
|
| |
|
