In this CSV seminar learn how to reduce validation project time, efficient documentation strategies, enhance system productivity and increase compliance with the New 21 CFR Part 11 regulations and how to use risk management for improving system performance and process improvement.

1. Full day Virtual Seminar - Effective Computer System Validation (CSV) and software
implementation to reduce cost/time and pass New 21 CFR Part 11 Inspections
January 19, Wednesday 10:00 AM EST | 05:00 PM EST
Why Should You Attend:
This interactive one-day virtual seminar provides proven techniques for reducing costs associated with implementing,
using and maintaining computer systems in regulated environments. Nearly every computerized system utilized in labo-
ratory, clinical, manufacturing and the quality process has to be validated. Learn efficient documentation strategies for
computer system validation and how to increase overall system productivity. Explore methods to decrease resource
requirements, and make documentation more manageable and understandable. This often results in a savings of two-
thirds the costs. Additionally, this course will help companies increase compliance with the new 21 CFR Part 11 regula-
tions and demonstrate how to use risk management to improve system performance and promote process improvement.
How It Works:
The webinar has a series of modules, each about 60 minutes long. Our speaker, Mr. David Nettleton, will deliver the
modules using PowerPoint slides. At the end of each module, there is an interactive portion where participants can ask
questions and clarify information. The modules also include multiple-choice questions to help participants assure they
understand the material. Some of the modules contain exercises for participants that help illustrate the points covered
and further increase learning. The interactive portion includes a discussion of the questions and exercises.
Date: January 19, Wednesday 2010
Time: 10:00 AM EST | 05:00 PM EST
Duration: 6 hrs
Instructor: David Nettleton
Location: Your office or conference room (no need to travel!)
Areas Covered in the Seminar:
1. Introduction to the FDA (60 Min)
Interactive discussion that builds the foundation for electronic records:
• Why the FDA regulates.
• How the regulations work together.
• Introduction to Part 11.
• Predicate rules.
• FDA and international standards.
• GAMP.
David Nettleton
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2. 2. 21 CFR Part 11 - Compliance for Electronic Records and Signatures (120 Min)
Interactive discussion that details the regulation and how it applies to computerized systems. What makes this session
unique is the understanding of how the concepts of Part 11 affect industry standards related to computer systems.
• Which data and systems are subject to Part 11.
• What Part 11 means, not just what it says.
• Avoid 483 and warning letters.
• Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documenta-
tion.
• Ensure data integrity and protect intellectual property.
• Current computer system industry standards for security, data transfer, and audit trails.
• Digital pens, electronic signatures, 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.
3. The Five Keys to COTS Computer System Validation (30 Min)
Interactive discussion of the fundamentals of user validation for Commercial Off-The-Shelf (COTS) software as required by
21 CFR Part 11. What makes this session unique is the complexity of the topic is restated in terms everyone can under-
stand.
• Apply the Who, What, Where, When, and Why of risk-based computer system validation.
• Understand the real life common errors and how to avoid them.
• Reduce staff resources, documentation, and project timelines.
• Real life examples to ensure success.
• Recommendations for performing efficient validation projects.
• How to use resources effectively.
• Increase compliance while lowering costs.
4. Selecting a Validation Team That Is Effective (30 Min)
Interactive discussion that describes how to assemble a validation team for maximum productivity and most efficient use
of resources.
• Members.
• Team characteristics.
• How to facilitate and how to lead.
• How to get the right people to work together so validation is efficient and takes only one-third the time.
5. How to Write Requirements and Specifications (30 Min)
Workshop exercises that teach how to write a requirement and then build upon it to write a specification. What makes this
session unique is the hands on experience of authoring as a team.
• How requirements and specification differ.
• What they have in common.
• How to author as a team.
• Workshop exercises.

3. 6. Software Testing – How to Reduce Time and Costs (30 Min)
Interactive discussion that details the role of testing within the risk-based validation approach in order to reduce time
and costs while ensuring process controls.
• Testing concepts and tools for efficient testing.
• Static vs. dynamic test methods.
• How to perform and document testing.
• How to track bugs and issues during testing.
• How to use testing to verify system acceptance without testing everything.
• Proven techniques for reducing testing time and documentation while improving defect detection.
• How to efficiently write and execute test cases.
• How to develop the testing protocol.
• How to reduce testing to one-third the time.
• It concludes with an array of testing strategies that improve quality and reduce testing time.
7. Cost Reduction Without Increasing Regulatory or Business Risk (60 Min)
Interactive discussion that summarizes the proven techniques that reduce validation project time, often to one-third. What
makes this session unique is the compilation of proven techniques that are not obvious until understood in the context of
the work being performed. It is especially good for managementand executives.
• Proven techniques that reduce software costs and
implementation times. How to load data.
• Increase corporate productivity and individual
workforce member productivity. How to reduce the
number of systems.
• How to use COTS software to lower costs.How to
integrate systems.
• Efficiently create validation documentation. How to
use VMware to lower costs.
* Decrease resource requirements. Increase com-
pliance and demonstrate how to use risk management
to improve system performance and promote process
improvement.
* Make documentation more manageable and un-
derstandable. How to implement a computer system
to gain maximum productivity.
* Avoid 483s and warning letters. Use resources
effectively to perform effective validation while avoid-
ing doing too much.
* How to use the help desk. Understand software
vendor claims and the deficiencies of their validation
packages.
• How to load data.
• How to reduce the number of systems.
• How to reduce the number of systems.
• How to use VMware to lower costs.
• Increase compliance and demonstrate how to use
risk management to improve system performance and
promote process improvement.
• How to implement a computer system to gain maxi-
mum productivity.
• Use resources effectively to perform effective vali-
dation while avoiding doing too much.
• Understand software vendor claims and the defi-
ciencies of their validation packages.

4. Duration:
6 hours of instruction, one hour lunch, 15 min breaks as they fit into the schedule.
Agenda:
• 10:00 AM EST – 11:00 AM EST - Module 1: Introduction to the FDA (60 Min)
• 11:00 AM EST – 01:00 PM EST - Module 2: 21 CFR Part 11 - Compliance for Electronic Records and Signatures (120
Min)
• 01:00 PM EST – 02:00 PM EST - Lunch Hour
• 02:00 PM EST – 02:30 PM EST - Module 3: The Five Keys to COTS Computer System Validation (30 Min)
• 02:30 PM EST – 02:45 PM EST - Module 4: Selecting a Validation Team That Is Effective (15 Min)
• 02:45 PM EST – 03:00 PM EST - Module 5: How to Write Requirements and Specifications (30 Min)
• 03:00 PM EST – 03:30 PM EST - Module 6: Software Testing – How to Reduce Time and Costs (30 Min)
• 03:30 PM EST – 03:45 PM EST - Afternoon Break
• 03:45 PM EST – 04:45 PM EST - Module 7: Cost Reduction Without Increasing Regulatory or Business Risk (60 Min)
• 04:45 PM EST – 05:00 PM EST - Q&A
Who Will Benefit:
• People that use computer systems in mission critical applications
• Ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, laboratory, manufacturing,
pharmaceutical, biotechnical, and medical device markets
• Also ideal for software developers and software vendors
• Participants learn valuable skills that make them more efficient users of any type of computer system
• Participants should have some experience in a GxP environment
Instructor Profile:
David Nettleton, is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software
validation, and computer systemvalidation. He is involved with the development, purchase, installation,
operation and maintenance of computerized systems used in FDA compliant applications. He has com-
pleted more than 196 mission critical laboratory, clinical, and manufacturing software implementation projects.
His most popular book is Risk Based Software Validation - Ten easy Steps (Davis Horwood International
and PDA - www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software
validation project.
Registration Information:
* Register Online. Use your American Express, Visa or MasterCard.
* For more than one attendee get 20% off on the price of additional attendee.
* Get your group to attend the webinar at a discounted price call +1- 650-620-3937.
* Call +1 - 650-620-3937 or Fax your PO: 650-963-2556.
* Mail your check to: ComplianceOnline (MetricStream, Inc), 2600 E. Bayshore Road, Palo Alto, CA 94303.
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