2014 - Webinar On Project Management for Computer Systems Validation
Date2014-08-08
Deadline2014-08-07
VenueOnline, Canada
KeywordsProject Management; Computer Systems Validation; Project management steps
Topics/Call fo Papers
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. 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 detailed webinar 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 in a more effective manner.
Areas Covered in the Session :
Basics of Project Management
21 CFR 11 and Computer Systems Validation (CSV)
Project Planning for a Computer Systems Validation Project
CSV Deliverables
Hiddent CSV Deliverables
Metrics & Gantt Charts
Common Pitfalls and How to Avoid them
The 10 Deadly Sins!!
Who Will Benefit:
Project Managers
IT Management
Business Process Owners
Quality Managers
Quality Engineers
GxP
Consultants
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more Information contact
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : 416-915-4458
Email : support-AT-compliancetrainings.com
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 detailed webinar 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 in a more effective manner.
Areas Covered in the Session :
Basics of Project Management
21 CFR 11 and Computer Systems Validation (CSV)
Project Planning for a Computer Systems Validation Project
CSV Deliverables
Hiddent CSV Deliverables
Metrics & Gantt Charts
Common Pitfalls and How to Avoid them
The 10 Deadly Sins!!
Who Will Benefit:
Project Managers
IT Management
Business Process Owners
Quality Managers
Quality Engineers
GxP
Consultants
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more Information contact
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : 416-915-4458
Email : support-AT-compliancetrainings.com
Other CFPs
- Webinar On The Quality System Regulation: FDA’s Medical Device GMP
- Webinar On Patient Compliance in Drug Trials
- Webinar On Risk Management in GMP Facilities
- Webinar On Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration
- Webinar On Statistical Analysis of Gages
Last modified: 2014-07-30 18:54:49