Course Description:
This interactive two-day 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 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
Seminar Fee Includes:
Who will Benefit:
This 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
Course Outline:
| Day One (8:00 AM – 5:00 PM) | Day Two (8:00 AM – 4:00 PM) | ||
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Registration Process: 8:00 AM – 8:30 AM Session Start Time: 8:30 AM 0. Introduction to class (1 hr)1. Introduction to the FDA (1 hr)
2. 21 CFR Part 11 - Compliance for Electronic Records and Signatures (3 hr)
3. HIPAA Compliance for Electronic Records (30 Min)
4. The Five Keys to COTS Computer System Validation (30 Min)
5. The Validation Team (30 Min)
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6. Ten-Step Process for COTS Risk-Based Computer System Validation (1 hr)
7. How to Write Requirements and Specifications (30 Min)
8. How to Conduct a Hazard Analysis/Risk Assessment-Exercise (1 hr)
9. Software Testing (1 hr)
10. System Change Control (30 Min)
11. Purchasing COTS Software (30 Min)
12. Cost Reduction Without Increasing Regulatory or Business Risk (1 hr)
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Meet Your Instructor
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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. 
Interview with
David Nettleton, FDA Compliance Specialist |
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