2-day In-person Seminar on “Software Validation for the New FDA Inspections - Electronic Records and Electronic Signatures: From 21 CFR Part 11 to HIP

Overview:

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.

·         IT

·         QA

·         QC

·         Laboratory staff

·         Managers

·         Regulatory Affairs

·         GMP, GCP, GLP professionals

Day 1 – Agenda

1.   Lecture 1: Introduction to the FDA

2.   Lecture 2: 21 CFR Part 11 - Compliance for Electronic Records and Signatures

3.   Lecture 3: HIPAA Compliance for Electronic Records

4.   Lecture 4: The Five Keys to COTS Computer System Validation

5.   Lecture 5: The Validation Team

Day 2 – Agenda

1.   Lecture 6: Ten-Step Process for COTS Computer System Validation

2.   Lecture 7: How to Write Requirements and Specifications

3.   Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise

4.   Lecture 9: Software Testing

5.   Lecture 10: System Change Control

6.   Lecture 11: Cost Reduction without Increasing Regulatory or Business Risk

7.   Lecture 12: Q & A

Speaker Profile:

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.

Date, Location and Price:

Venue:Mandarin Orchard Singapore 

Address: 333 Orchard Road, Singapore 238867 

Date: December 5th & 6th | 9 AM to 6 PM

Location: Singapore

Price: $1595.00

Discount: Register now and save $200. (Early Bird)
Until October 20, Early Bird Price: $1,595.00 
from October 21 to December 03, Regular Price: $1,795.00

Contact Information:
Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email: support@globalcompliancepanel.com

Website: https://www.globalcompliancepanel.com

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