Software Validation for the New FDA Inspections

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...

Pharmaceuticals/Drug Discovery, Medical & Health Care

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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 warningare the other benefits of this seminar.

For whom:
This seminar will benefit professionals in/amongthe following areas:
o IT
o QA
o QC
o Laboratory staff
o Managers
o Regulatory Affairs
o GMP, GCP, GLP professionals

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).