Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.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
Who will Benefit:
- GMP, GCP, GLP, regulatory professionals
- QA/QC
- IT
- Auditors
- Managers and directors
- Software vendors, SaaS hosting providers
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
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 Virtual Seminar Agenda of this event.
Time: 9:00 AM - 3:00 PM PDT
Venue
The venue is not yet available for this event.
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