|
| |
 |
The Trainer
Tim Stein
CEO , Business Performance Associates, Inc |
|
|
Venue and Date
Bangalore - December 12, 2006
Time:
10:00 am - 5.30 pm |
|
 |
Training Seminar on FDA Computer System Validation
As part of Global Compliance Series of seminars, ComplianceOnline brings you the expert view on “Training Seminar on FDA Computer System Validation” by Tim Stein,
Ph.D., is the founder and CEO of Business Performance Associates, Inc. (BPA), a consulting firm that specializes in both quality systems for biomedical companies and computer system validation. Tim is the author of Computer System Risk Management and Validation Life Cycle which is scheduled for release in April 2006 by Paton Press. Tim has written a set of policy and procedure documents and templates for computer system validation that are available through ComplianceOnline.
This training and tool kit provides you with the knowledge and basic tools needed to validation computer systems.
ComplianceOnline brings your Business Performance Associates' comprehensive training seminar that provides you everything you need to perform computer system validations. On-site training, easy-to-use procedures and templates, and a detailed how-to manual combine to provide a complete set of tools and knowledge for efficiently conducting validations of software used in production and quality systems. Such validations are required for compliance with US-FDA Quality System Regulation (212 CFR 820 70i) and ISO 13485 (7.5.2.1).
The program provides you the knowledge you need to validate computer systems, a consistent methodology that meets FDA compliance requirements for validation, and time saving tools for creating validation deliverables.
This course was developed by and will be presented by Tim Stein, a recognized leader in the field of software validation. Tim has just published the first technical manual to integrate computer system validation, risk management, and system implementation into a single, easy-to-use process. The book is titled The Computer System Risk Management and Validation Life Cycle and was published in September by Paton Press. The RiskVal Life Cycle taught in the course and described in the book is applicable to all industries where computer systems pose a substantial risk to business continuity, efficiency, and the integrity of high-value data. Easily understood by system users, and QA and IT professionals, this course explains basic concepts and translates them into how-to deliverables. It simplifies the tough decisions associated with the validation and management of failure associated with a wide range of systems.
Procedures
You will receive Word files of four computer system validation procedures that document the validation method that you will learn. ISO 13485 and the US FDA require that the validations of computer systems and changes to those systems be done according to defined procedures. You will receive a procedure for computer system validation, and another for change control to validation systems. The third procedure defines the requirements for the common validation deliverables. And, the fourth document, a template, provides extensive instructions and examples for creating an operational qualification protocol. Here is a list of the four documents.
|
