|Date||2013-07-01 to 2013-07-02|
|Address||The LaLiT Mumbai Sahar Airport Road, Andheri East, Mumbai - 400059|
|Exhibition hall||The LaLiT Mumbai|
· This course will teach you how to reduce software validation costs by as much as two thirds.
· It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation.
· The course is highly interactive, using real life examples and proven techniques.
· You will learn how to use electronic records and electronic signatures to maximize productivity.
· 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.
· 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.
· Learn how to reduce testing time, and how prepare documents that avoid 483s and warning letters.
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 Lecture 12: Q & A
Who Will Benefit:
GMP, GCP, GLP professionals
DATE, VENUE & PRICE:
On 01st and 02nd July, 2013 in Mumbai
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.
Toll free: +91 80-3247-3694, +91 80-3201-4957
Fax: 302 288 6884
NetZealous Services India Pvt. Ltd.
4th Floor, 'A' Block, Brigade Software Park,
Banashankari 2nd stage,
Bangalore - 560070 INDIA.
Contact: +91 80-3247-3694
Address: The LaLiT Mumbai Sahar Airport Road, Andheri East, Mumbai - 400059
Mobile: +91 80-3201-4957
Tel: +91 80-3247-3694
Fax: 302 288 6884