Overview: This webinar is intended for executives 2012 - Software Validation Planning for Executives and Managers - Webinar By GlobalCompliancePanel
Date2012-07-25
Deadline2012-07-25
VenueWilmington, USA - United States
KeywordsSoftware V&V Protocols, Documentation, Risk Management models, process/equipment control,cGMP data / Part 11 applications.
Websitehttp://alturl.com/259mz
Topics/Call fo Papers
Overview: This webinar is intended for executives and managers, and explains the business fundamentals of regulatory compliance. It explains what does and does not need to be validated. It describes exactly what is required for compliance with 21 CFR Part 11. This webinar details how to assign team members, increase productivity, and lower costs.
Areas Covered in the Session:
What are the fundamentals of regulatory compliance?
Understand what the regulations mean, not just what they say.
How to avoid 483 and Warning Letters.
Which SOPs and validation documents are required?
Understand the current computer system industry standards for security, data transfer, audit trails, and electronic signatures.
How to lower costs, though reduction in resources, and reduction in documentation.
How to increase productivity by promoting efficient validation and use of computer systems.
Who Will Benefit:
QA
Managers
Executives
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.
Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00
Phone: 800-447-9407
Fax: 302-288-6884
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
http://alturl.com/259mz
Areas Covered in the Session:
What are the fundamentals of regulatory compliance?
Understand what the regulations mean, not just what they say.
How to avoid 483 and Warning Letters.
Which SOPs and validation documents are required?
Understand the current computer system industry standards for security, data transfer, audit trails, and electronic signatures.
How to lower costs, though reduction in resources, and reduction in documentation.
How to increase productivity by promoting efficient validation and use of computer systems.
Who Will Benefit:
QA
Managers
Executives
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.
Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00
Phone: 800-447-9407
Fax: 302-288-6884
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
http://alturl.com/259mz
Other CFPs
- Software V&V Protocols and Documentation - Webinar By GlobalCompliancePanel
- Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO)- Webinar By GlobalCompliancePanel
- Avoiding Statistical Pitfalls during Method Validation - Webinar By GlobalCompliancePanel
- The FDA Inspection Process: From SOP to 483 - Webinar By GlobalCompliancePanel
- IEC 62304 for Medical Device Software Development: Steps to Compliance - Webinar By GlobalCompliancePanel
Last modified: 2012-06-28 13:35:23