New Live Webinar Series in Collaboration with Compliance Online
Computer Validation Foundations: Common Sense Compliance

Date:

February 12, Tuesday 12:00 PM EST 09:00 AM PST

Event:

Part 1 The Auditable Validation Package

Instructor:

Teri Stokes, Ph.D., Director GXP International

Topics:

• The four major themes common to all computer related regulations
• A common strategy for preparing all computer validation packages
• Variations on the common strategy for preparing auditable OQ, IQ, and PQ packages
• Industry standard outlines for Validation Plans and Test Plans and why you need both types of plans
• Audit criteria for reviewing computer validation documentation
• The roles of QC and QA in computer validation
  

Location:

Your own office or conference room

Duration:

60-70 minutes

Your Price:

$249.00

Registration Link:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=700709

Who Will Benefit:

• System validation teams
• QA & QC professionals
• Software suppliers selling into Bio/Pharmaceutical markets – QA, QC, SDLC managers
• IT managers and staff
• End user purchasers of computerized systems for use in regulated environments – GCP, GLP, GMP, 21 CFR Part 11
• Auditors and consultants

New Live Webinar Series in Collaboration with Compliance Online
Computer Validation Foundations: Common Sense Compliance

Date:

March 11, Tuesday 12:00 PM EST 09:00 AM PST

Event:

Part 2 Auditable Testing Practices

Instructor:

Teri Stokes, Ph.D., Director GXP International

Topics:

• Role and structure for user requirements specifications (URS)
• Role and structure for test script traceability matrix
• Roles and responsibilities for test coordinator, test script author, reviewer, tester, and witness.
• Industry standard outlines for test plans and test summary reports.
• The different types of testing performed by software developers (OQ), IT analysts (IQ), and end users (PQ).
• What auditors expect to see
  

Location:

Your own office or conference room

Duration:

60-70 minutes

Your Price:

$249.00

Registration Link:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=700710

Who Will Benefit:

• System validation teams
• QA & QC professionals
• Software suppliers selling into Bio/Pharmaceutical markets – QA, QC, SDLC managers
• IT managers and staff
• End user purchasers of computerized systems for use in regulated environments – GCP, GLP, GMP, 21 CFR Part 11
• Auditors and consultants

New Live Webinar Series in Collaboration with Compliance Online
Computer Validation Foundations: Common Sense Compliance

Date:

April 15, Tuesday 12:00 PM EST 09:00 AM PST

Event:

Part 3 Staying Validated

Instructor:

Teri Stokes, Ph.D., Director GXP International

Topics:

• Roles for end user, IT support, and software supplier in the operational phase of a validated system’s life cycle
• Content and structure for a system’s configuration management log binder
• Change control process and practices
• Backup and retrieval practices
• Different roles for online backups, electronic archive, off site storage, and escrow account
• Ongoing system training and materials
• Different roles for business continuity plans and disaster recovery plans
• What auditors expect to see
  

Location:

Your own office or conference room

Duration:

60-70 minutes

Your Price:

$249.00

Registration Link:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=700711

Who Will Benefit:

• Project Managers
• Project Leaders
• Management Representatives
• Management
• Validation Team Members & those closely involved in an ISO 9001:2000 Project

Half Day Tutorial for Onsite Delivery – The CRA Role in EDC Trials

Date:

Half Day Tutorial available on a contract basis

Event:

The CRA Role for Compliance with Electronic Data Capture (EDC)

Instructor:

Teri Stokes, Ph.D., Director GXP International

Topics:

Monitoring data quality and integrity has long been the CRA role in GCP compliant clinical studies. Now that this data is most often electronic, the CRA is faced with new challenges.

• This busy three hour workshop provides both training and tools for non-IT oriented CRAs to help them fulfill their compliance monitoring role.
• We will look at the regulations (GCP, HIPAA, and 21 CFR Part 11) and guidance (CSUCT) for common themes.
• We will look at the site level impact on data integrity of EDC technologies for e-CRFs, e-Diaries, and interactive voice response (IVR) systems.

Participants will be actively involved in tutorial discussions, group work, and case study analysis using tools that can be applied to future studies.

Location:

This workshop was enthusiastically received at the June 2007 Annual DIA meeting in Atlanta, GA. It is now available for delivery to clients on a contract basis.

Duration:

3 Hours

Registration Link:

Send a query to GXPINTL@RCN.COM

Who Will Benefit:

CRAs, monitors, study coordinators, and protocol teams that develop and conduct clinical trials using electronic data capture such as electronic case report forms (eCRFs), interactive voice response (IVR) systems for randomization and management of supplies or patient response by phone, and electronic patient diaries (e-diaries) using hand held devices.