2-day In-person Seminar on “Software Validation for the New FDA Inspections” at Hotel Lalit, Mumbai

Computer systems need to be compliant in relation to a few important areas. Some areas of regulation relating to implementation of computerized systems can be worked out for better results.

Online PR News – 09-May-2013 – Mumbai – What the seminar is about:
Computer systems need to be compliant in relation to a few important areas. Some areas of regulation relating to implementation of computerized systems can be worked out for better results. When more enhanced and effective software validation systems are put in place, an organization can save hugely on resources and time.

Helping participating organizations achieve all these is the aim of this seminar. It will help participants reduce software validation costs by as much as two thirds. During two days of high interaction studded with real life examples and proven techniques; the speaker, David Nettleton will bring the full strength of his experience in the field and detail all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation.

Participants will learn how to use electronic records and electronic signatures to maximize productivity. They will also be able to prepare for an audit and will benefit IT, QA, laboratory, clinical, and manufacturing staff, as well as software vendors.
A grasp of advanced concepts such as how to "right size" change control methods that allows quick and safe system revalidation and reducing testing time, and preparing documents that avoid 483s and warning are the other benefits of this seminar.
Venue: The venue for this seminar is The Lalit Mumbai, Sahar Airport Road, Andheri East in Mumbai. The seminar working hours are from 9 A.M to 6 P.M on both the days.
About the Speaker: Founder of Computer System Validation (CSV), David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA and Computer System Validation. His latest book, Risk Based Software Validation –Ten easy Steps, relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.

An accomplished author, David has written extensively on a range of Compliance issues. He is co-author of Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA - www.pda.org), and Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC - www.crcpress.com).

The seminar:
This is the agenda of this seminar:

Day 1 –Agenda
Lecture 1: Introduction to the FDA
Lecture 2: 21 CFR Part 11 –Compliance for Electronic Records and Signatures
Lecture 3: HIPAA Compliance for Electronic Records
Lecture 4: The Five Keys to COTS Computer System Validation
Lecture 5: The Validation Team

Day 2 – Agenda
Lecture 6: Ten-Step Process for COTS Computer System Validation
Lecture 7: How to Write Requirements and Specifications
Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise
Lecture 9: Software Testing
Lecture 10: System Change Control
Lecture 11: Cost Reduction without Increasing Regulatory or Business Risk
Lecture 12: Q & A
For whom:
This seminar will benefit professionals in/among the following areas:
o IT
o QA
o QC
o Laboratory staff
o Managers
o Regulatory Affairs
o GMP, GCP, GLP professionals
About GlobalCompliancePanel:
GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and compliance-related services relating to Medical Devices, Pharmaceutical, FDA, Food, PCI industries, and SOX. Some of the Governing Areas its webinars cover are GxP (Manufacturing/Clinical/Lab), EU and ISO.
These seminars are an extension of online trainings, at which GCP has conducted around 700 webinars since inception on a variety of topics for these industries /verticals. More than 30,000 professionals have benefited from these trainings. GlobalCompliancePanel’s trainings are focused, flexible and tailored to the client’s need.

Price: INR 18,000
Register now and save INR 2000 (Early Bird)
Until May 18, Early Bird Price: INR 18,000.
From May 19 to June 30, Regular Price: INR 20,000.
Group participations
Discount Slab: 5 or more participants get a 10% discount
To avail the above group discounts, all the participants should register by making a single payment.
Contact Information:
Toll free: 1800 425 9409
Call: +91 80-3247-3694
Call: +91 80-3201-4957
Fax: 080 26421483