This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.
- It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation.
- 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.
- 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.
- The instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.
- Participants will learn how to write a Data Privacy Statement to comply with the EU General Data Protection Regulation (GDPR).
- This course benefits anyone that uses computer systems to perform their job functions and is ideal for 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.
Learning Objectives:
- Reduce costs, usually by two-thirds, for compliance with electronic records
- Learn how to use electronic records and electronic signatures to maximize productivity
- Understand what is expected in Part 11 and Annex 11 inspections so you are prepared
- Avoid 483 and Warning Letters
- Understand the responsibilities and specific duties of your staff including IT and QA
- Understand your responsibilities and liabilities when using SaaS/cloud
- Learn how to perform risk-based Computer System Validation using fill-in-the-blank templates
- How to select resources and manage validation projects
- "Right size" change control methods that allows quick and safe system evolution
- Minimize validation documentation to reduce costs without increasing regulatory or business risk
- Learn how to reduce testing time and write test cases that trace to elements of risk management
- Learn how to comply with the requirements for data privacy
- Learn how to buy COTS software and qualify vendors
- Protect intellectual property and keep electronic records safe
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
Who will Benefit:
- GMP, GCP, GLP, regulatory professionals
- QA/QC
- IT
- Auditors
- Managers and directors
- Software vendors, SaaS hosting providers
- Introduction to the FDA (1:30 hr)
- 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 (3:30 hr)
- What Part 11 means to you, not just what it says in the regulations
- Avoid 483 and Warning Letters
- Explore the four primary areas of Part 11 compliance: SOPs, software product features, infrastructure qualification, 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 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.
- The Five Keys to COTS Computer System Validation (30 Min)
- The Who, What, Where, When, and Why of CSV
- The Validation Team (30 Min)
- How to select team members
- How to facilitate a validation project
- Ten-Step Process for COTS Risk-Based Computer System Validation (30 Min)
continued on day 2
- Software demonstrations and discussions (30 Min)
- Ten-Step Process for COTS Risk-Based Computer System Validation (30 Min)
- 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).
- How to Write Requirements and Specifications (30 Min)
- Workshop for writing requirements and then expanding them for specifications
- How to Conduct a Hazard Analysis/Risk Assessment-Exercise (30 Min)
- Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
- Software Testing (30 Min)
- Reduce testing by writing test cases that trace to elements of risk management.
- How to write efficient test cases
- How to write a Data Privacy Statement (30 Min)
- How to meet the requirements of the EU GDPR
- Purchasing COTS Software (30 Min)
- How to purchase COTS software and evaluate software vendors
- Cost Reduction Without Increasing Regulatory or Business Risk (45 Min)
- How to save money
- How to increase quality
- How to increase compliance with less documentation
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.
Testimonials
See What People Say About Us
System Admin, IT
Business System Analyst
Director of Quality
Test Engineer
Software and Training Support Specialist
Director, Validation
Business System Analyst
Manager, IT
VP Global CRM & Business Solutions
Business System Analyst, Documentation
Test Engineer
Sr. Manager, IT
Director Technical Services
Director, Agile Systems and Processes
Business Systems Manager
Project Engineer
Software Quality Assurance
Global Quality Operations Analyst
Software Vendor, Vancouver, BC
Technical Writer
Contract Research Organization, Los Angeles, CA
Pharmaceutical company, San Francisco, CA
Lisa Wyeth
Lead Auditor
Sr. Validation Engineer
Associate Director
QA/RA Manager
Sr. Validation Engineer
Information Technology Specialist
IT Director
Project Manager
The registration was an easy process. I forwarded the information to our Human Resources and they were able to handle it from the beginning.
GCP Manager
Assistant Manager of Technical Development
Software Quality Manager
Engineering Electrical Controls Manager
Director - Global IT Governance
Sr. QA Engineer
Associate Director, Quality Operations
Lead Auditor/Sr. Laboratory Compliance Specialist
He explained very well the concepts and gave good examples however is when we do things by our selves that we better understand and make the concepts "ours" The place and lightening was fine, there was no noise interrupting.
Software Validation Engineer
Research & Development Associate
Director of Regulatory Affairs,
Nickell Physician & Pharmacy Services