LAS VEGAS, Aug. 15, 2016 /PRNewswire/ -- NetZealous LLC, a leading provider of regulatory compliance trainings for a wide range of regulated industries, will organize a two-day seminar through its premier brand GlobalCompliancePanel, in Las Vegas, NV on the topic, "Verification vs. Validation - Product Process Software and QMS" on September 29 and 30, 2016. John E Lincoln, a senior Consultant on Medical device and Regulatory Affairs, will be the Director of this seminar.
The Director, 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.
More details about the seminar can be had from
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.
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.
About the Director:
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.
"Creating a Master Validation Plan that meets the cGMP requirements is very crucial for companies, and this seminar imparts this understanding thoroughly," said Satisha Naraharimurthy, Founder and CEO of NetZealous LLC.
Shahanshah Manzoor, Co-Founder and Chief Marketing Officer at NetZealous LLC is hopeful that participating organizations will be able to implement their Quality Systems much more effectively in compliance with the FDA, ICH and ISO requirements after attending this seminar.
"Getting the QMS right is the basis to the creation of a sound Master Validation Plan. This seminar will help participants attain this without hassles," opined Liju Mathew, Co-Founder and Chief Business Development Officer at NetZealous.
NetZealous LLC, a Fremont, CA-registered organization, DBA GlobalCompliancePanel offers a broad range of high quality regulatory and compliance-related professional trainings and services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biologicals, drugs, food and biotechnology.
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