- 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
- 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
Introduction to the FDA
- How the regulations help
your company to be successful
- Which data and systems
are subject to Part 11
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
- 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
The Five Keys to COTS Computer System Validation
- The Who, What, Where,
When, and Why of CSV
Day 2 Schedule
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 - www.pda.org, 2006).
How to Write Requirements and Specifications
- Workshop for writing
requirements and then expanding them for specifications
How to Conduct a Hazard Analysis/Risk
instructions for performing and documenting a risk assessment, and how to
use the results to reduce validation documentation.
- Reduce testing by
writing test cases that trace to elements of risk management.
- How to write efficient
System Change Control
- How to manage a
validated system with minimal documentation
Purchasing COTS Software
- How to purchase COTS
software and evaluate software vendors.
Cost Reduction Without Increasing Regulatory or
- How to save money
- How to increase quality
- How to increase
compliance with less documentation
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
- Managing the
Documentation Maze - Answers to Questions You Didn't Even Know to Ask
(Wiley - www.wiley.com) 2010
- 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, 2004)
Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance
(Davis Horwood International and PDA - www.pda.org, 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:
NetZealous DBA as GlobalCompliancePanel
Registration Link -
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