US Seminar on “Software Validation for the New FDA Inspections” (Software Validation for the FDA Inspection)

Organization: GlobalCompliancePanel

Venue: Hilton Hotel

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Apr 18, 2013 / 9:00 am - (PST) End Date/Time: Apr 19, 2013 / 6:00 pm - (PST)
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Description

 

Overview:

  • 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.

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

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.

Location & Venue: 

Philadelphia | April 18th & 19th, 2013 (Thursday & Friday)

HOTEL - DoubleTree by Hilton Hotel Philadelphia Center City 

237 South Broad Street, Philadelphia, Pennsylvania, 19107-5686, USA

from 9 am to 6 pm EDT at DoubleTree by Hilton Hotel Philadelphia 

Contact Information: GlobalCompliancePanel Event Coordinator

Toll free: 800-425-9409

Fax: 302-288-6884

http://www.globalcompliancepanel.com

Email: support@globalcompliancepanel.com

Price: $1,295.00

GlobalCompliancePanel,

USA, Livermore Common, Fremont,

CA 94539, USA Phone: 1800 425 9407

Venue

Hilton Hotel
237 South Broad Street
Philadelphia
Pennsylvania
United States
MORE INFO ON THIS VENUE

Organizations

GlobalCompliancePanel
Livermore Common
Fremont
California
94536
United States

Conference Speakers

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.

Additional Information

Day 1 - Agenda Full Details:

Lecture 1: Introduction to the FDA

  • How the regulations help your company to be successful
  • Which data and systems are subject to Part 11.

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

  • What Part 11 means to you, not just what it says in the regulation.
  • Avoid 483 and Warning Letters.
  • Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
  • Ensure data integrity, security, and protect intellectual property.
  • Understand the current computer system industry standards for security, data transfer, and audit trails.
  • Electronic signatures, digital pens, and biometric signatures.
  • SOPs required for the IT infrastructure.
  • Product features to look for when purchasing COTS software.
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents.

Lecture 3: HIPAA Compliance for Electronic Records

  • How Part 11 and HIPAA interrelate
  • What are the additional requirements for patient data

Lecture 4: The Five Keys to COTS Computer System Validation

  • The Who, What, Where, When, and Why of CSV

Lecture 5: The Validation Team

  • How to select team members
  • How to facilitate a validation project

Day 2 - Agenda Full Details:

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

  • Learn which documents the FDA expects to audit.
  • How to use the risk-based validation approach to lower costs.
  • How to link requirements, specifications, risk management, and testing.
  • Document a computer system validation project using easy to understand fill-in-the-blank templates.
  • Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).

Lecture 7: How to Write Requirements and Specifications

  • Workshop for writing requirements and then expanding them for specifications

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

  • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.

Lecture 9: Software Testing

  • Reduce testing by writing test cases that trace to elements of risk management.
  • How to write efficient test cases

Lecture 10: System Change Control

  • How to manage a validated system with minimal documentation

Lecture 11: Cost Reduction Without Increasing Regulatory or Business Risk

  • How to save money
  • How to increase quality
  • How to increase compliance with less documentation

Lecture 12: Q & A

Exhibits included

 

Who Will Benefit:
  • IT
  • QA
  • QC
  • Laboratory staff
  • Managers
  • Regulatory Affairs
  • GMP, GCP, GLP professionals