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Date(s) - 01/07/2013 - 02/07/2013
9:00 am - 6:00 pm


  1. This course will teach you how to reduce software validation costs by as much as two thirds.
  2. It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation.
  3. The course is highly interactive, using real life examples and proven techniques.
  4. You will learn how to use electronic records and electronic signatures to maximize productivity.
  5. This course will teach you how to prepare for an audit and is intended for IT, QA, laboratory, clinical, and manufacturing staff, as well as software vendors.
  6. The instructor starts with the basics and covers advanced concepts such as how to “Right size” change control methods that allows quick and safe system revalidation.
  7. Learn how to reduce testing time, and how prepare documents that avoid 483s and warning letters.

Course Outline:

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

Who Will Benefit:

  1. IT
  2. QA
  3. QC
  4. Laboratory staff
  5. Managers
  6. Regulatory Affairs
  7. GMP, GCP, GLP professionals

About Speaker David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is Risk Based Software Validation – Ten easy Steps. It relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.

He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 225 mission critical software validation projects.


On 01st and 02nd July, 2013 in Mumbai
from 9 am to 6 pm at The LaliT Mumbai

Venue: The Lalit Hotel, Sahar Airport, Andheri East.

Price:  Rs 18,000.

Register now and save 2000 (Early Bird)

Until May 18, Early Bird Price: Rs 18,000.

From May 19 to June 30, Regular Price: Rs 20,000.

Contact Information:
Event Coordinator

Toll free:  +91 80-3247-3694, +91 80-3201-4957

Fax:  302 288 6884



Event Link –


NetZealous Services India Pvt. Ltd.

4th Floor, ‘A’ Block, Brigade Software Park,

Banashankari 2nd stage,

Bangalore – 560070.  INDIA.


This event is fully booked.