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Compliance for software validation in 21 CFR Part 11 - 2017

Thursday, Jul 06, 2017 at 8:30AM - Friday, Jul 07, 2017 at 5:00PM

Zurich, Switzerland

  • Jul 2017

    06 Thu


  • Jul 2017

    07 Fri


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Compliance for software validation in 21 CFR Part 11 - 2017

Thursday, Jul 06, 2017 at 8:30AM - Friday, Jul 07, 2017 at 5:00PM

Opfikon, CA

No tickets available


  • This interactive two-day
    course explores proven techniques for reducing costs associated with
    implementing, using, and maintaining computer systems in regulated
  • Many companies are
    outsourcing IT resources and getting involved with Software as a Service
    (SaaS) and cloud computing. These vendors are not regulated and therefore
    regulated companies must ensure compliance for both infrastructure
    qualification and computer system validation. It is the regulated company
    that wants to avoid FDA form 483s and warning letters. The seminar is
    intended for regulated companies, software vendors, and SaaS/Cloud providers.
  • The instructor addresses
    the latest computer system industry standards for data security, data
    transfer, audit trails, electronic records and signatures, software
    validation, and computer system validation.
  • Today the FDA performs
    both GxP and Part 11 inspections, the Europeans have released an updated
    Annex 11 regulation that expands Part 11 requirements and companies must
    update their systems and processes to maintain compliance.
  • This seminar will help
    you understand the specific requirements associated with local and
    SaaS/cloud hosting solutions.
  • Nearly every
    computerized system used in laboratory, clinical, manufacturing settings
    and in the quality process has to be validated.
  • Participants learn how
    to decrease software implementation times and lower costs using a 10-step
    risk-based approach to computer system validation.
  • Finally, the instructor
    reviews recent FDA inspection trends and discusses how to streamline
    document authoring, revision, review, and approval.
  • This course benefits
    anyone that uses computer systems to perform their job functions and is
    ideal for regulatory, clinical, and IT professionals working in the health
    care, clinical trial, biopharmaceutical, and medical device sectors. It is
    essential for software vendors, auditors, and quality staff involved in
    GxP applications.


  • Understand what is
    expected in Part 11 and Annex 11 inspections
  • Avoid 483 and Warning
  • Learn how to buy COTS
    software and qualify vendors.
  • Implement a computer
    system using risk-based validation to gain maximum productivity and reduce
    cost by as much as two thirds
  • Requirements for local,
    SaaS, and cloud hosting
  • How to select resources
    and manage validation projects
  • "Right size"
    change control methods that allows quick and safe system evolution
  • Minimize the validation
    documentation to reduce costs without increasing regulatory or business
  • Write test cases that
    trace to elements of risk management
  • Protect intellectual
    property and keep electronic records safe

Who will benefit:

  • QA, IT, management
  • all GxP system users


Day 1 Schedule

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/Annex 11 - Compliance for Electronic
Records and Signatures

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

Lecture 3:

The Five Keys to COTS Computer System Validation

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

Day 2 Schedule

Lecture 1:

Ten-Step Process for COTS Risk-Based Computer System

  • 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
  • Based on:
    "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood
    International and PDA -, 2006).

Lecture 2:

How to Write Requirements and Specifications

  • Workshop for writing
    requirements and then expanding them for specifications

Lecture 3:

How to Conduct a Hazard Analysis/Risk

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

Lecture 4:

Software Testing

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

Lecture 5:

System Change Control

  • How to manage a
    validated system with minimal documentation

Lecture 6:

Purchasing COTS Software

  • How to purchase COTS
    software and evaluate software vendors.

Lecture 7:

Cost Reduction Without Increasing Regulatory or
Business Risk

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


David Nettleton

FDA Compliance Specialist

Computer System Validation's
principal, David Nettleton is an industry leader, author, and teacher for 21
CFR Part 11, Annex 11, HIPAA, software validation, and computer system
validation. He is involved with the development, purchase, installation,
operation and maintenance of computerized systems used in FDA compliant
applications. He has completed more than 260 mission critical laboratory,
clinical, and manufacturing software implementation projects. His most popular
book is Risk Based Software Validation - Ten easy Steps, which provides
fill-in-the-blank templates for completing a COTS software validation project.

Services are available to guide
companies to create and maintain the systems and procedures required to pass
regulatory inspections: product features, vendor audits, software validation,
SOPs, training, gap analysis, remediation plans, and project management.

Projects involve: medical
devices, blood bank, clinical trial, corrective action, document control,
electronic data capture, Excel spreadsheets, laboratory instruments, laboratory
information management (LIMS), manufacturing, enterprise resource planning,
toxicology systems, and VMWare.

David Nettleton is also the
co-author of:

  • Managing the
    Documentation Maze - Answers to Questions You Didn't Even Know to Ask
    (Wiley - 2010
  • Electronic Record
    Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45
    CFR Parts 160, 162, and 164 (Interpharm/CRC -, 2004)
  • Commercial
    Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance
    (Davis Horwood International and PDA -, 2003).

Location: Zurich, Switzerland Date:July 6th and 7th, 2017and Time: 9:00
AM to 6:00 PM

Venue: Hilton Zurich Airport

Address: Hohenbuhlstrasse 10, 8152
Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50


$1,695.00 (Seminar Fee for One Delegate)

Register for 5 attendees  
Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*

May 25, Early Bird Price: $1,695.00 from May 26 to July 04, Regular Price:

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884



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