2014 - The Most Common Problems with Software Validation Processes
Date2014-08-20
Deadline2014-08-20
VenueOnline Event, USA - United States
KeywordsCompliance Training; Regulatory Training; Pharma; Clinical; Health
Topics/Call fo Papers
Overview:
This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation. It provides details for company compliance including GAMP, qualification, and validation. It teaches the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures. The webinar details the common problems and how to avoid them.
Areas Covered in the Session:
Learn how to avoid 483 and Warning Letters.
Which software needs validation and which does not?
Understand GAMP, qualification, and validation.
Learn what the regulations mean, not just what they say.
Examine the regulatory requirements for the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
Understand the current computer system industry standards for security, data transfer, audit trails, and electronic signatures.
Learn the Who, What, Where, When, and Why of computer system validation.
Who Will Benefit:
IT
QA
QC
Laboratory staff
Managers
GMP, GCP, GLP professionals
Quick Contact:
GlobalCompliancePanel
USA Phone:800-447-9407
Fax: 302-288-6884
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Event Link - http://bit.ly/V0nmYb
This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation. It provides details for company compliance including GAMP, qualification, and validation. It teaches the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures. The webinar details the common problems and how to avoid them.
Areas Covered in the Session:
Learn how to avoid 483 and Warning Letters.
Which software needs validation and which does not?
Understand GAMP, qualification, and validation.
Learn what the regulations mean, not just what they say.
Examine the regulatory requirements for the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
Understand the current computer system industry standards for security, data transfer, audit trails, and electronic signatures.
Learn the Who, What, Where, When, and Why of computer system validation.
Who Will Benefit:
IT
QA
QC
Laboratory staff
Managers
GMP, GCP, GLP professionals
Quick Contact:
GlobalCompliancePanel
USA Phone:800-447-9407
Fax: 302-288-6884
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Event Link - http://bit.ly/V0nmYb
Other CFPs
- Measurement Uncertainty in Microbiology
- Quality Management Systems - Creating, Implementing and Improving
- Excel Spreadsheet Validation for FDA 21 CFR Part 11
- ICH GCPs and the Clinical Research Process (Including Phase 0,1,2,3 and Phase 4 trials)
- IEEE Transactions on Services Computing Special Issue on Big Data Analytics, Infrastructure, and Applications
Last modified: 2014-07-14 15:27:05