Seminar on Verification vs. Validation - Product Process Software and QMS at Las Vegas, NV

Overview:

This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer & 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.

Agenda:

Day 1 Schedule:

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

Day 2 Schedule:

Lecture 1:

Software V&V documentation "model"

Lecture 2:

Software V&V protocols - "black box", "white box"

Lecture 3:

Electronic Records and Electronic Signatures (Part 11)

Lecture 4:

Summary of morning discussion

Lecture 5:

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

Lecture 6:

Review of group activity and Q&A

Lecture 7:

Course summary discussion

Lecture 8:

Summary of morning discussion

Lecture 9:

Group activity on the MVPs

Lecture 10:

Review of group activity and Q&A

Speaker

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. 

Venue: Hilton Grand Vacations Suites at the Flamingo

Hotel: Hilton Grand Vacations Suites at the Flamingo   3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109-4313, USA

Date: October 15th & 16th, 2015

Time: 9:00 AM to 6:00 PM

Price: $1,695.00 (Seminar for One Delegate)

Register now and save $200. (Early Bird) Until August 31, Early Bird Price: $1,695.00 From September 01 to October 13, Regular Price: $1,895.00

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

support@globalcompliancepanel.com  

http://www.globalcompliancepanel.com

Event Registration Link: https://goo.gl/Rxmg70