Live-In-Person Seminar on ”Verification vs. Validation – Product, Process, Software and QMS” at Las (Verification vs. Validation)

Venue: Harrah's Las Vegas

Location: Las Vegas, Nevada, United States

Event Date/Time: May 02, 2013 / 9:00 am - (PST) End Date/Time: May 03, 2013 / 6:00 pm - (PST)
Early Registration Date: Apr 30, 2013 Time: 22:00:00 - (PST)
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Description

 

Join us for a 2- day Seminar where we bring on John E. Lincoln, who is the Principal of J. E. Lincoln and Associates LLC, a consulting company. John, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. In this course, he will review the company Master Validation Plan for major key inputs and CGMP deficiencies and address the FDA's newer and tougher regulatory stance.

Why you should attend:

This session helps participants:

1.      Understand Verification and Validation, differences and how they   work together;

2.      Discuss recent regulatory expectations;

3.      Know how to document a "risk-based" rationale, and use it in a resource-constrained environment;

4.      Determine key "milestones" and "tasks" in a project;

5.      Locate and document key subject "inputs";

6.      Compile "generic" Master and Individual Validation Plans;

7.      Learn the key element of a Product V&V File/Protocol;

8.      Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;

9.      Get a grasp of basic Test Case construction;

10.  Understand sample sizes and their justification;

11.  Learn the key elements of Software V&V expected by the FDA and how to document;

12.  Deal with hardware and software vendors, sales and marketing

13.  Consider a field-tested software V&V documentation "model";

14.  See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11.

 

Participants will also understand how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11 through the use of practical application in two hands-on sessions.

Please note the registration will be closed two days (48 hours) prior to the start date of the seminar.

Call our representative on 1800 447 9407 to have your seats confirmed.

Limited seating, bookings essential!

Price: $1,295.00

Register now and save $200. (Early Bird) Until March 29, Early Bird Price: $1,295.00  from March 30 to April 30, Regular Price: $1,495.00

 

DATE, VENUE & PRICE:

Location: Las Vegas | May 2nd & 3rd, 2013 | 9 AM to 6 PM EDT

Hotel: Hilton Grand Vacations Suites at the Flamingo

Address: 3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109

 

Contact Information: Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email: support@globalcompliancepanel.com

GlobalCompliancePanel

NetZealous LLC, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

 

Venue

3475 Las Vegas Blvd. S.
Las Vegas
Nevada
United States
MORE INFO ON THIS VENUE

Conference Speakers

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company. John, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and 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 have been described in peer-reviewed technical articles and workshops worldwide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt.

Additional Information

 

What the seminar is about:

The speaker, John E. Lincoln, will conduct this two-day course on company Master Validation Plan for key inputs and CGMP deficiencies. The FDA has come up with a newer and tougher regulatory stance. This course addresses this. It proceeds to give participants an understanding of how to prepare a “risk based” document and use it in a resource constrained environment.

The expert will then go on to demonstrate “Product Risk Based V&V” by sufficient, targeted and documented risk-based V&V test case elements/scripts. More importantly, the speaker will help participants understand and evaluate the elements of V and V in relation to ISO 14971 and ICH Q9 for hazard analysis and product risk management.

This seminar will help participants:

a)     Determine key “milestones” and “tasks” in a project;

b)     Locate and document key subject “inputs”;

c)      Compile “generic” Master and Individual Validation Plans;

d)     Learn the key element of a Product V&V File/Protocol;

e)     Develop Process and/or Production/Test Equipment V&V Files/Protocols;

f)       Get a grasp of basic Test Case construction;

g)     Understand sample sizes and their justification;

h)     Learn the key elements of Software V&V expected by the FDA and how to document;

i)       Deal with hardware and software vendors, sales and marketing

j)       Consider a field-tested software V&V documentation “model”

Participants will also understand how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11 through the use of practical application in two hands-on sessions.

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About the Speaker:

John E. Lincoln, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and 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 have been described in peer-reviewed technical articles and workshops worldwide.

John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt.

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Agenda

This is the agenda of this seminar:

Day 1

Lecture 1: Master Validation Planning and the Master Validation Plan(s)

Lecture 2: Product, Process / Equipment Hardware V&V

Lecture 3: Product / Device V&V

Lecture 4: Software V&V

Lecture 5: Quality Management System / 21 CFR Part 11 V&V

Lecture 6: Summary of morning discussion

Lecture 7: Group activity on the MVPs

Lecture 8: Review of group activity and Q&A

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Day 2

Lecture 9: Software V&V documentation "model"

Lecture 10: Software V&V protocols –"black box", "white box"

Lecture 11: Electronic Records and Electronic Signatures (Part 11)

Lecture 12: Summary of morning discussion

Lecture 13: Group activity on 1) hardware / equipment, and 2) software V&V protocols

Lecture 14: Review of group activity and Q&A

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

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For whom:

This seminar will benefit professionals in/among the following areas:

1.       Senior and middle management and staff

2.      Regulatory Affairs

3.      Quality Assurance or Quality Control Professionals

4.      QA/QC

5.      IT/IS

6.      R&D

7.      Production Management

8.      Manufacturing Engineers

9.      Process Engineers

10.   Software Engineers

11.    Project Managers

12.   Hardware and software vendors, sales and marketing

13.   Any professional tasked with V&V responsibilities

Exhibits included

This workshop will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and V&V activities / plan(s). This information addresses Medical Devices, Pharmaceutical, Diagnostic, and Biologics requirements and implementation. The employees who will benefit include:

  • Senior and middle management and staff
  • Regulatory Affairs
  • Quality Assurance or Quality Control Professionals
  • QA/QC
  • IT/IS
  • R&D
  • Production Management
  • Manufacturing Engineers
  • Process Engineers
  • Software Engineers
  • Project Managers
  • Hardware and software vendors, sales and marketing
  • Any professional tasked with V&V responsibilities