A risk based approach to GxP Compliant Laboratory Computerized Systems training seminars presented by ComplianceOnline register now on FindaSeminar.com

findaseminar logo balls FindaSeminar.com
event search registration and marketing services since 2002
Advanced Search
 
 

A risk based approach to GxP Compliant Laboratory Computerized Systems  

 Email information about this seminar A risk based approach to GxP Compliant Laboratory Computerized Systems by ComplianceOnline to yourself your manager or associates Email this event... View and register for other training seminars like A risk based approach to GxP Compliant Laboratory Computerized Systems by ComplianceOnline on FindaSeminar.com Find similar training.. Find and register for other training seminars by ComplianceOnline on FindaSeminar.com Other seminars from ComplianceOnline

By:

training seminars by ComplianceOnline ComplianceOnline   

For:

VP of IT, Director of IT, Quality Managers, Project Managers (for CSV / IT), Validation Specialists, Database Administrators, System Administrators, Directors / Senior Directors of Discovery, Directors / Senior Directors of Development

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation. (see full course description)

 

 Seminar / Training class dates & locations

 

No seminar dates for this event are currently scheduled.  Please use the seminars search box above or choose one of the following additional training search options to find similar training.

testing+computerized+gxp+systems+data+integrity+GaMP5+lifecycle+supplier+planning+execution+operational+phase+migration+compliance training seminars workshops conferences online training

Providers course catalog

Find seminars by state

Find seminars by city

Request on site training

Use Advanced Search

NEW  Don't miss training you want to attend

Receive a personal Training Alert when training you want to attend comes to your area. Create a personal Training Alert now  it's Free and only takes a minute!


 

 

 

share this page 

print the agenda print agenda for the A risk based approach to GxP Compliant Laboratory Computerized Systems seminar

 

 

Training Course Syllabus:


Course Description

Laboratory Computerized Systems and data management operations are increasing in variety, sophistication and complexity in the GxP environment. Widespread reliance on these systems, along with their potential impact on data integrity, and the trend towards cost efficiency within companies, means that companies need achieve GxP compliance of laboratory computerized systems– within a reasonable budget and timeline. The wide diversity of these systems, coupled with their capability for networking, makes it impractical and inefficient to have single approach to achieve GxP compliance for all systems. For example, a High Performance Liquid Chromatography (HPLC) with a Photo Diode Array (PDA) detector is much more complex than a pH meter, and will require a correspondingly more detailed and complex implementation, control and maintenance approach.


Learning Objectives:

  • Examining the system life cycle and its applicability for most laboratory computerized systems
  • Identifying characteristics that distinguish various types of laboratory computerized systems
  • Developing a rationale for scaling activities and effort based upon risk, complexity, and novelty
  • Defining a strategy for supplier assessments, and the effective leveraging of supplier knowledge, experience, and documentation
  • Applying the GAMP® 5 Quality Risk Management (QRM) approach
  • Defining necessary operational and maintenance activities
  • Recommending an approach to system retirement
  • Leveraging deliverables and activities for very similar or identical systems

  • DAY 01(8:30 AM - 4:30 PM)

  • Lecture 1: Introduction and Background
  • Lecture 2: Quality Risk Management
  • Lecture 3: Life Cycle Approach
  • Lecture 4: Life Cycle Phases

  • DAY 02(8:30 AM - 4:00 PM)

  • Lecture 5: GxP Compliance
  • Lecture 6: Risks & Implementation of Systems
  • Lecture 7: Supplier Documentation & Services
  • Quiz: Jeopardy!!!!
  • Seminar Summary:

    This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation. (see full course description)

    print this agenda print agenda for the A risk based approach to GxP Compliant Laboratory Computerized Systems training seminar

     view dates and locations for this seminar

     

     

     

    Custom Search