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Drafting a Software V&V Documentation Package and Protocol - Webinar by GlobalCompliancePanel
This Webinar is over| Date | Mar 18, 2014 |
| Time | 01:00 PM EDT |
| Cost | $245.00 |
|
Online
|
Overview:
The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.
This webinar will address the use of the FDA, DAMP, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, to structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based". How can this be realistly accomplished.
This webinar will address software that is:
Areas Covered in the Session:
Who Will Benefit:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
Contact Information:
NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.
This webinar will address the use of the FDA, DAMP, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, to structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based". How can this be realistly accomplished.
This webinar will address software that is:
- As-Product;
- In-Product;
- In Production and Test Equipment; and
- The Quality System.
Areas Covered in the Session:
- Verification or Validation
- Current Regulatory Expectations and “Hot Buttons”
- The Project Validation Plan
- Product and Process / Equipment Software V&V
- When and How to Use DQ, IQ, OQ, PQ
- GAMP Considerations
- The FDA's 11 Key Elements
- "White Box" and "Black Box" Validations
Who Will Benefit:
- Senior management, Project Leaders, Internal / External consultants
- Mid-level Management and Supervisory Personnel
- Regulatory Affairs
- Quality Systems Personnel / QAE
- R&D and Engineering Staff
- New Product Development Personnel
- Validation Technicians
- IT Department
- Medical Device, Equipment / Process SW Programmers
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
Contact Information:
NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
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