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. The practice of Project Management within the highly regulated world of the FDA inspected industries provides unique challenges and opportunities.
It is considered good project management practice to integrate Data Integrity, Computer Systems Validation, 21 CFR 11 and Annex 11 with relevant project management activities to ensure that compliance risk is managed effectively and proactively. This presentation provides good practice approaches which promote the successful integration of Computer Systems Validation requirements.
In this Session speaker explain the Basics of Project Management and Computer Systems Validation, 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.
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 that fosters data integrity, 21 CFR 11 & Annex 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.
Areas Covered in the Session:
- Provide specific guidance on project management for csv
- Provide a reproducible project delivery system
- Enable project stakeholders to understand the complexities of running a project
- Explain integration of risk management into specific aspects of a project
- Explain integration of different aspects of a pharmaceutical project which cross both functional and organizational boundaries, which need to be managed proactively
- Provide a quick way for estimating length and cost of a project
- PART 1: Background, Basics, Context: 60 Minutes
- Basics of Project Management
- What is the difference between Data Integrity, Computer Systems Validation, 21 CFR 11 and Annex 11?
- Basics of Computer Systems Validation
- Project Planning for a Computer Systems Validation Project
- Common Pitfalls and How to Avoid them
- What is FDA's most current thinking related to computers and electronic records?
- What are the inspection trends?
- What are most frequent recent citations for Part11?
- What are the most frequent deviations for computer system validation?
- How important is risk based Part11 compliance?
- PART 2: Project Management for Computer Systems Validation Detail 1 - 60 Minutes
- People Management
- Risk Management
- Project Initiation
- Project Delivery Planning
- Design Planning & Delivery
- PART 3: Project Management for Computer Systems Validation Detail 2 - 60 Minutes
- Implementation: Procurement
- Implementation: Construction
- Implementation: Testing & Commissioning
- Project Close-Out
Ms Angela Bazigos,
Touchstone Technologies Silicon Valley
Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.