A highly interactive two-day course on reducing costs for compliance with data integrity has been added to ComplianceOnline.com’s offering.
The 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 and helps 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 will 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 also learn how to write a Data Privacy Statement to comply with the EU General Data Protection Regulation (GDPR).
- 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 allow quick and safe system evolution
- Minimize the 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
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.
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.
For more information about this seminar visit https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=capitalbay
ComplianceOnline.com is a leading provider of regulatory/compliance training for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 60,000 professionals from 10,000+ companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at https://www.complianceonline.com.