Read Frequently Asked Questions
Project Management for Computer Systems Validation
This computer system validation training will highlight the principles of project management that can be applied to 21 CFR Part 11 compliance for Computer Systems Validation and show how you can use project management tenets to deliver on time and on budget, while meeting FDA regulatory compliance requirements.
Why Should You Attend:
Per the CDRH, 20% of product recalls in the medical device industry are due to faulty software!!! Yet, these human, financial and reputation capital expensive issues can be averted with computerized systems validation and “21 CFR 11 Compliance”. Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company’s product.
The Project Manager for a validated computerized system has to deliver on time and on budget, but with the added risk of having to meet regulatory compliance, often causing project overruns, regulatory findings and missed times to market.
This 2-hr training session will explain the basic tenets of project management, the basic tenets of “21 CFR 11 Compliance” for Computer Systems Validation and will show how to integrate the two, to deliver on time and on budget while meeting regulatory compliance requirements.
Areas Covered in the Seminar:
- Basics of Project Management.
- 21 CFR 11 Compliance for Systems Validation.
- Basics of Computer Systems Validation.
- Project Planning for a Computer Systems Validation Project.
- Common Pitfalls and How to Avoid them.
- Successfully Implementing System Validation And Avoiding FDA Warning Letters.
Who Will Benefit:
- Project Managers
- IT Management
- Business Process Owners
- Quality Managers
- Quality Engineers
- Pharmaceutical Compliance Officers
- Biotech Professionals
- Medical Device Professionals
- Anyone involved with the FDA
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley and has almost 30 years experience in lifescience. She has received a patent for speeding up software compliance and has applied for patents aimed at speeding up software compliance and FDA software audits. She has co-authored “Computerized Systems in Clinical Research” with the FDA, DIA and Academia and teaches classes in project management, computer systems validation, quality assurance and IT. She is the Vice President of the Pacific Regional Chapter of Society of Quality Assurance and writes articles for the SQA journal. She is also a member of DIA, RAPS and CVIC. She was recently inducted into Stanford’s Who’s Who for contributions to the LifeSciences industry.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email email@example.com or call +1-650-620-3937.
This training hasn't been reviewed yet.
A Systematic Approach To Writing Effective Standard Operating Procedures (SOPs) Responding to FDA 483s and FDA Warning Letters - Best Practices Best Practices With Submissions Under Medical Device User Fee Act (MDUFA) III