Verification vs. Validation - Product, Process, Software and QMS by GlobalCompliancePanel


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									                                                                                    Phone: 800-447-9407

2-day In-person Seminar on

Verification vs. Validation - Product,
Process, Software and QMS

Location: Las Vegas | January 17th & 18th, 2013 | 9 AM to 6 PM EST                    Register Now

                                                 Course "Verification vs. Validation - Product,
By John E. Lincoln
                                                 Process, Software and QMS" has been pre-approved
Price: $1,295.00 (for 1 attendee)
                                                 by RAPS as eligible for up to 12 credits towards a
Register now and save $200. (Early Bird)
                                                 participant's RAC recertification upon full completion.

Course Outline: Day 1:                                                                     John E Lincoln
Lecture 1: Master Validation Planning and the Master Validation                            Consultant,
                                                                                           Medical device
                                                                                           and Regulatory
Lecture 2: Product, Process / Equipment Hardware V&V                                       affairs,
Lecture 3: Product / Device V&V
Lecture 4: TSoftware V&V
Lecture 5: Quality Management System / 21 CFR Part 11 V&V                 John E. Lincoln is Principal of J.
Lecture 8:Summary of morning discussion                                   E. Lincoln and Associates LLC, a
                                                                          consulting company. John, a
Lecture 7: Group activity on the MVPs                                     graduate of UCLA, is a medical
Lecture 8: Review of group activity and Q&A                               device and Regulatory Affairs
                                                                          consultant. He has helped
Course Outline: Day 2:                                                    companies to implement or modify
                                                                          their GMP systems and
Lecture 9: Software V&V documentation "model"                             procedures, product risk
                                                                          management and U.S. FDA
Lecture 10: Software V&V protocols - "black box", "white box"
                                                                          responses. In addition, he has
Lecture 11: Electronic Records and Electronic Signatures (Part 11)        successfully designed, written and
                                                                          run all types of process,
                                                                          equipment and software
Lecture 12: Summary of morning discussion                                 qualifications/validations, which
Lecture 13:Group activity on 1) hardware / equipment, and 2)              have passed FDA audit or
                                                                          submission scrutiny, and have
software V&V protocols                                                    been described in peer-reviewed
Lecture 14:Review of group activity and Q&A                               technical articles and workshops
Lecture 15:Course summary discussion
Lecture 16:Summary of morning discussion
Lecture 17:Group activity on the MVPs
Lecture 18:Review of group activity and Q&A


This course will review the company Master Validation Plan for major key inputs and CGMP
deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to
prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case
elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for
hazard analysis and product risk management.

This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ
equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM
E2500, all against a background of limited company resources.

Who Will Benefit:

    l   Senior and middle management and staff             
    l   Regulatory Affairs
    l   Quality Assurance or Quality Control
                                                                      WILL BE ANNOUNCED SOON
    l   QA/QC
    l   IT/IS
    l   R&D                                                                Register Now
    l   Production Management
    l   Manufacturing Engineers                            
    l   Process Engineers
    l   Software Engineers
    l   Project Managers
    l   Hardware and software vendors, sales and
    l   Any professional tasked with V&V responsibilities

It would be really nice if you can circulate this mail to all your deserving colleagues who can
immensely benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,

About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model
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professionals & providing a forum for expert speakers/panelists to render their services through simplified
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CA 94539, USA

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