This Software Validation training will guide you on how to maintain compliance while downsizing with reduce costs and Increase compliance with lowering resource needs to avoid 483s warning letters.
Why Should You Attend:
This course explores proven techniques that reduce validation project time, often to one-third. 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 cost. Additionally, this course will help companies increase compliance and demonstrate how to use risk management to improve system performance and promote process improvement.
Areas Covered in the seminar:
- Significantly lower costs and reduce software implementation time.
- Proven techniques that reduces software costs and implementation times
- Increase corporate productivity and individual workforce member productivity
- How to use COTS software to lower costs
- Efficiently create validation documentation
- Decrease resource requirements
- Make documentation more manageable and understandable
- Avoid 483s and warning letters
- How to use the help desk
- How to load data
- How to reduce the number of systems
- How to integrate systems
- How to use VMware to lower costs
- Increase compliance and demonstrate how to use risk management to improve system performance and promote process improvement
- How to implement a computer system to gain maximum productivity
- Use resources effectively to perform effective validation while avoiding doing too much
- Understand software vendor claims and the deficiencies of their validation packages
Who will benefit:
This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- 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 good computer skills and some experience in a GxP environment
Instructor Profile:
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is “Risk Based Software Validation - Ten easy Steps” that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.
