Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PriceWaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compl Read more
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, 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.
Course Objective:
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. 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 class 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 marry the two, to deliver on time and on budget while meeting regulatory compliance requirements.
Course Outline:
• Basics of Project Management
• Basics of Computer Systems Validation
• Project Planning for a Computer Systems Validation Project
• Common Pitfalls and How to Avoid them
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Project Managers
• IT Management
• Business Process Owners
• Quality Managers
• Quality Engineers
• GxP
• Consultants
2-hr Virtual Seminar: FDA Inspections - Understanding the Core Elements
LIVE : Scheduled on
20-May-2024 :01:00 PM EDT
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21 CFR 58 - Good Laboratory Practice (GLP) and USP 1058 Validations
LIVE : Scheduled on
30-May-2024 :01:00 PM EDT
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6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?
LIVE : Scheduled on
18-June-2024 :11:00 AM EDT
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6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
LIVE : Scheduled on
19-June-2024 :11:00 AM EDT
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6-hr Virtual Seminar: Medical Device Regulations and Evolving Requirements: Post Market Surveillance, Complaint Handling, eMDR, Recalls, UDI Regulations & Emerging Signals
LIVE : Scheduled on
25-June-2024 :11:00 AM EDT
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