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The Trainer
Vimarie Ortiz
Principal with Processo Partners, Inc. |
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Venue and Date
Hyderabad - September 24, 2007
New Delhi - September 26, 2007
Time:
10:00 am - 5.30 pm |
| Who Will Benefit: |
- Quality Assurance
- Information Technology
- Software Quality Engineers
- Developers
- Testers
- Project and Functional Managers
- Functional Analysts, and other organizational stakeholders
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| Industry References: |
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This course introduces principles and requirements discussed in the FDA, “Computerized Systems Used in Clinical Investigations”, Guidance for Industry, 2007; FDA, Part 11, “Electronic Records; Electronic Signatures — Scope and Application”, Guidance for Industry, 2003; FDA, “General Principles of Software Validation”; Final Guidance for Industry and FDA Staff, 2002; FDA, 21 CFR Part 11, "Electronic Records; Electronic Signatures; Final Rule." Federal Register, 1997 |
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| Course Materials: |
Attendees will be given the following suite of tools:
- ProFlash quick reference cards with Part 11 key concepts
- Example solutions to all course exercises
- Copies of presentation materials Topic Assessments
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Training Seminar on FDA 21 CFR Part 11 Compliance in Practice and Computer System Validation
As part of Global Compliance Series of seminars, ComplianceOnline brings you the expert view on “FDA 21 CFR Part 11 Compliance in Practice and Computer System Validation” by Vimarie Ortiz, is a principal with Processo Partners, Inc., a consulting software compliance technologies company in South Florida specializing in all aspects of Computer Systems Validation.
FDA 21 CFR Part 11 Compliance in Practice and Computer System Validation is a course designed to provide fundamental knowledge, and practical skills to anyone interested in implementing or improving their 21 CFR Part 11 knowledge and practices in their organizations. The course starts with an overview of the 21 CFR Part 11 fundamentals that include the criteria to identify applicable electronic records or signatures and the organizational documents that drive their applicability; offers a Part 11 model to establish organizational compliance and remain compliant; discusses the process to validate systems for Part 11, by software category; and ends with a special presentation on how to prepare an organizational interpretation of the Part 11 ruling.
Course attendees will learn how to:
- Identify applicable systems
- Identify applicable and not applicable electronic records and signatures
- Develop a 21 CFR Part 11 plan for their organization
- Assess systems for Part 11
- Remediate systems for Part 11 gaps
- Validate systems for Part 11
- Develop an organizational 21 CFR Part 11 ruling interpretation document
Outline of Conference
| MORNING SESSION - 10:00 AM - 1:30 PM |
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- Introduction to 21 CFR Part 11
- Definitions & Applicability
- Part 11 Riders
- Part 11 Regulation
- Part 11 Applicability
- Predicate Rules
- Types of Systems
- Paper-based Systems
- Hybrid Systems
- Electronic Systems
- Closed Systems
- Open Systems
- Electronic Records Applicability
- Electronic records that apply
- Electronic records that do not apply
- Criteria to identify applicable electronic records
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- The 21 CFR Part 11 Organizational Path
- 5 Steps to 21 CFR Part 11 Compliance
- Gather Systems Inventory
- Identify Applicable Systems
- Perform Gap Assessments
- Develop Remediation Plan
- Implement & Manage Plan
- Staying in Compliance with 21 CFR Part 11
- Management Controls
- Internal Audits & Inspections
- Education
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| AFTERNOON SESSION - 2:30 PM - 5:30 PM |
- Validating Systems for Part 11
- Pre-requirements
- System GxP Assessment
- System Part 11 Assessment
- Validation Strategy
- Retrospective Validation
- Prospective Validation
- Validation Scope
- Category 3 Systems (COTS As Is) Assessments
- Category 4 Systems (COTS Configured)
- Category 5 Systems (Custom)
- Other
- Interpretation of Part 11 Ruling
- Validation Process
- The Part 11 User Requirements
- Developing the Validation Strategy
- Planning for Testing
- Acceptance Testing
- System Testing
- Integration Testing
- Unit Testing
- Testing
- Verification vs. Validation
- Resources involve
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- Interpretation of 21 CFR Part 11 Ruling
- Subpart A – General Provisions
- Scope (21 CFR Part 11.1)
- Implementation (21 CFR Part 11.2)
- Definitions (21 CFR Part 11.3)
- Subpart B – Electronic Records
- Controls for Closed Systems (21 CFR Part 11.10)
- Controls for Open Systems (21 CFR Part 11.30)
- Signature Manifestation (21 CFR Part 11.50)
- Signature/ record linking (21 CFR Part 11.70)
- Subpart C – Electronic Signatures
- General Requirements (21 CFR Part 11.100)
- Electronic signature components and controls (21 CFR Part 11.200)
- Controls for identification codes/ passwords (21 CFR Part 11.300
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