Course Description:
This
Computer System Validation
Training course will explore proven techniques for reducing costs
associated with implementing, using, and maintaining computer systems in
regulated environments. 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.
Many companies
outsource IT resources and are involved in 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 to avoid FDA form 483s and Warning Letters.
This
Computer System Validation
Training course is intended for these regulated companies, software
vendors, and SaaS/cloud providers. The seminar instructor will:
- Address
the latest computer system industry standards for data security,data
transfer, audit trails, electronic records and signatures, software
validation, and computer system validation.
- Help participants understand the specific requirements associated with local and SaaS/cloud hosting solutions.
- Illustrate
the importance of validating the quality process and every computerized
system used in laboratory, clinical, and manufacturing settings.
- Demonstrate
how to decrease software implementation times and lower costs using a
10-step risk-based approach to computer system validation.
- Review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.
Learning Objective:
- Understand what is expected in Part 11 and Annex 11 inspections
- Avoid 483s and Warning Letters
- 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 risk
- Write test cases that trace to elements of risk management
- Protect intellectual property and keep electronic records safe
Really good location with good lunch. This seminar was full of valuable topics.
System Admin, IT
This is my first experience with ComplianceOnline and I would definitely attend other seminars.
Business System Analyst
It
was a knowledgeable seminar. Thanks for inviting me. I will attend
upcoming seminars on ISO 13485 and Sterilization validation.
Director of Quality
I love to receive your email alerts. It keeps me updated with all valuable trainings. You have variety of offerings.
Test Engineer
Meet Your Instructor
David Nettleton
FDA Compliance Specialist, Computer System Validation
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 230 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.
Please fill in your name and email to receive the seminar agenda of this event.
The agenda is available as PDF under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.
Who will Benefit:
This CSV Training Course will benefit all who
use 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.
- Regulatory Affairs
- QA/ QC
- IT/IS
- Software Managers
- Project Managers
- Software vendors and suppliers
Venue
Venue to be confirmed
San Francisco, CA