Ofni Systems presents at numerous conferences and workshops on Part 11 and regularly conducts training sessions for organizations to educate employees about the specific requirements of the rule and how to incorporate it into daily practices.
Let Ofni Systems make knowledge management simple for you. Contact us today for for more information about these events.
2010
Prepare for FDA CSV Inspections – Review of Recent Enforcement Actions, 483’s and Warning Letters
The FDA has been expanding their audit programs and the number of observations related to validation problems has been steadily increasing. New requirements for Risk Assessments have been appearing, as well as a number of observations related to change control This session will focus on what the agency is looking for in your validation program by reviewing recent 483’s and warning letters related to computer system validations. Key points that will be covered include:
- Current FDA Requirements and Expectations for Validation
- Review of recent 483's and Warning letters
- Consequences of Validation Gaps
- A checklist of the top observations to avoid
Presented by Tyson M. Mew, President, Ofni Systems, Inc.
11th Annual Computer and Software Validation
April 21 - 23, 2010,
San Diego, CA
Presented by IVT
Automate Your CSV Process – Templates, Tools, & Tricks
This course will discuss:
Getting Started – Preparing to Automate your CSV Practices
- Discuss why CSV is well-suited to automation
- Preparing templates for documents and certain types of systems
- Determine and execute your testing strategy
- Formalize your strategy in a Validation Master Plan
- Implement best practices for lean project management
Automation of CSV Document Generation
- Breaking down systems into discrete validatable objects
- Collecting testable requirements
- Automatically create your list of testable objects
- Generating Design Specifications directly from source code
- Integrating Risk Assessments into the process
- Automatic generation, tracking and updating of the Requirements Traceability Matrix
Test Cases and Test Plans
- How much testing is enough? Testing based on Risk Assessments
- Input testing, Challenge Testing, Unit & Workflow test cases
- Automating common test scripts with mini-test cases
- Create specific test cases for use with change control
- Auto-creation of test scripts from your requirements
Protocol Execution, Documentation and Managing Deviations
- Paper vs. Electronic execution
- Capturing actual results and screen shots for maximum effectiveness
- Generating, processing and closing test and script deviations
Interactive Exercise: Case Studies of CSV Automation Success Stories
Several case studies will be presented to demonstrate how different types of validation projects were automated using the techniques described above. We will also discuss how the FDA is using automation for spreadsheet validation in their own labs.
Presented by Tyson M. Mew, President, Ofni Systems, Inc.
11th Annual Computer and Software Validation
April 21 - 23, 2010,
San Diego, CA
Presented by IVT
2009
21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets
Hundreds of 483's and warning letters are received each year by companies who did not design or validate their databases and spreadsheets to meet Part 11 requirements.
In this webinar you will learn how to implement Part 11 requirements in databases (Access, Oracle, and SQL Server) and Excel spreadsheets.
This presentation will provide the instructions, and documentation to ensure full compliance with 21 CFR Part 11, including:
- Strategies for how to document and validate Access databases and other software applications based on databases.
- How to add audit trails to databases and spreadsheets
- How to define requirements quickly.
- Managing change control and common change control mistakes to avoid.
- How to document inputs, code and security settings.
- How to properly secure the data and code.
- Access security settings for multiple users.
- Common settings applied to limit user actions.
- Details on when and where to use electronic signatures.
- Advanced techniques for adding electronic signatures
- Inactivity timeouts, and controls for users and passwords.
- Tips for efficient database testing.
- Learn about how the FDA secures their own databases and spreadsheets
December 17, 2009
e-Conference, Presented by the Executive Conference Corporation
How to Validate Device and Computer Software
Computer software validation has been a major issue for medical device manufacturers and is one of the leading causes of 483 observations, warning letters and product recalls. There are many different types of computer hardware and software found in the medical device industry, including:
- COTS (Commercial Off-The-Shelf) applications
- Custom in-house applications (databases and spreadsheets, web applications, etc)
- Software embedded in medical devices
- Software used to create or manufacture devices
All of the above must be validated for intended use and be under strict change control. The risk to patients can be severe for even small software bugs, and the cost of legal actions or product recalls can be financially devastating. The following topics will be covered in detail:
- A review of recent enforcement actions as a result of inappropriate computer system validations.
- The basics of computer software validation and what is expected in any validation effort.
- A presentation of Ofni System's methodology for how we create functional requirements, design specifications and test cases.
- Education for users about specific hot spots, including Change Control and Risk Assessments.
- A discussion of new technologies for automated testing and electronic protocol execution.
July 8, 2009
e-Conference, Presented by the Clinical Device Group
How to Conduct a GAP Analysis of your CSV Program
Use of Macros and Spreadsheets in Regulated Environments
Tyson Mew, president of Ofni Systems will speak at IVT's 10th Annual Computer and Software Validation conference.
May 18-20th, 2009
Presented by IVT
21 CFR Part 11 Compliance and Validation for MS Access Databases
Mr. Tyson Mew will address validation and 21 CFR 11 with regard to usage of Access databases. By properly securing your databases, you can allow a much wider audience to use and benefit from every database within the organization. The following topics will be covered in detail:
- How to add audit trails to any part of the database
- How to properly secure the data and code
- Access database security settings for multiple users
- Common settings to apply to limit user actions
- Learn what the FDA will look for during audits
- Managing change control and common mistakes to avoid
- Details on when and where to use Electronic Signatures
- Database testing and techniques for software validation
Attendees will receive instructions for how to apply controls to their own access programs. In additions, attendees may download sample code and validation documents for their own use.
February 18, 2009
e-Conference, Presented by the Clinical Device Group
How to Make Excel Part 11 Compliant
Mr. Derek Wimmer will address validation and part 11 with regard to your usage of Excel spreadsheets. You will learn what your options are and how to address the issues for the different categories of spreadsheets use. He will address:
- What Excel is used for
- Different categories of spreadsheets
- Relevant regulations and history
- Excel’s lack of compliance features
- Where we are today with respect to Part 11 and enforcement
- Options available to address Excel’s shortfalls
- Applying those options to the different categories of spreadsheets
- Managing the whole process
- How to approach the issue if it's an emergency and you have no money/time/resources
February 4, 2009 at 11:00 am
e-Conference, Presented by the Clinical Device Group
2008
QCSV Inc. & Regulatory Compliance Committee of the Medical Devices Cluster
Proper Use & Validation of Excel Spreadsheets in an FDA Regulated Environments - The presentation began with a discussion of documentation practices and validation methodology. Functional requirements define all appropriate formulas, charts and associated macros. Design requirements define the specific formulas, chart settings and stored code.
Formulas are tested first by confirming that the formula used is appropriate for the intended calculation and second by confirming that the formula gives the appropriate result. Macros are tested by entering a range of data and comparing the results with a hand calculator, or by visual inspection that the function performed as expected. Charts are tested by a combination of visual inspection or verification of the properties, including the data set used as the basis for the charts. Security testing is dependent on how security has been implemented, but at a minimum, security testing should demonstrate that users are limited to entering data into the defined input cells only and that users do not have the ability to alter any other part of the spreadsheet.
San Juan, PR
October 30, 2008
IVT Validation Week at the DoubleTree Hotel
FDA Validation Inspections and Latest Trends - The FDA is in the process of modernizing and expanding their inspections. The FDA has hired 1300 new doctors and scientists, including 245 new field inspectors, and is spending $2.5 billion to modernize their information technology. The FDA expects that all computer systems which control Quality and Production data must be validated and the data within must be controlled. The principle method of demonstrating control of computer systems is validation.
Most observations relating to validation are due to missing or incomplete validations. Other common causes of validation observation come from companies not following their own validation procedures, or for omitting mandated technological controls like audit trails or security.
Examples of specific observations can be found here.
Computer System Remediation & Validation for Regulatory Inspection - A Case Study - The presentation started with a discussion of validation policies and procedures. There was a discussion of the pros and cons of the V-model of validation. This lead into a discussion of specific validation techniques, including automated document generation, micro test cases, automated requirement traceability and parallel requirement development. Software testing techniques were also discussed, including the use of virtual machines, electronic protocol execution, documenting protocol execution with screen shots and automated deviation reporting.
The second section of the presentation defined basic approaches to validating custom databases, spreadsheets, web applications and LIMS connections.
The final section of the presentation reviewed specific case studies. These included a large group of spreadsheets used by a CRO, an engineering system for pharmaceutical manufacturer, an electronic document capture system, a purchasing system for a pharmaceutical manufacturer and a CRO database which was completely validated within 12 business days.
Philadelphia, PA
October 22 - October 23, 2008
Validation of MS Access Databases published by askaboutValidation.com
Published June 2008
"This article will present a simple method for validating MS Access databases for GXP use. The goal of our validation strategy is to provide better testing and documentation of individual databases in less time. Once we establish this methodology, we can rapidly apply it to many databases to reach compliance faster.
This article will cover the most common examples of database validation activities. We will cover special or very complicated examples whenever possible, but anything not explicitly covered in this article can be added as needed to fit your existing validation requirements or for special cases."
Click here to read the article.
Validation of MS Excel Spreadsheets published by askaboutValidation.com
Article of the month for May 2008
"This article will present a simple method for validating MS Excel spreadsheets for GXP use. The goal of our validation strategy is to provide better testing and documentation of individual spreadsheets in less time. Once we establish this methodology, we can rapidly apply it to many spreadsheets to reach compliance faster.
This article will attempt to cover the most common examples of spreadsheet validation activities that we find. We will attempt to cover special or very complicated examples whenever possible, but it should be understood that anything not explicitly covered in this article can be added as needed to fit your existing validation requirements or for special cases."
Click here to read the article.
2007
Audio Seminar - Validation and Use of MS Access Databases in GxP and Part 11 Environments
August 23, 2007
"Access databases are a simple way to meet many of the data collection and record keeping requirements required by the FDA but they also need to meet the technical requirements of 21 CFR Part 11, Electronic Records, Electronic Signatures. Out-of-the box Access has not been designed for regulated environments. This event will show you how to make Access databases Part 11 compliant."
Registration/Order Recording
2006
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Journal of Validation Technology®
Volume 12, Number 4, August 2006
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Using Automation To Generate Validation Documents And Add Part 11 Compliance
The author has created software that automates the validation of computer software systems and generates validation documentation. This article will take you through the step-by-step process of how that process can be applied. The system can also be used to track the system's functional requirements over the life of the system. See how such a system may be of use in its many applications in your environment.
Training Course - Part 11 Compliance for MS Access
"Building 21 CFR Part 11-Compliant Applications"
Presented by FDA News and Ofni Systems
Raleigh, NC
March 30-31, 2006
WebEx Seminar - MS Access & Part 11: A Visual Presentation
Presented for the Clinical Device Group
February 16, 2006
11:00-12:30 CST
2005
2nd Annual FDA Information Management Summit at the Bethesda Hyatt
Bethesda, MD
November 30 - December 2, 2005
IVT Laboratory Regulations, Controls & Compliance
Nov. 29 – Dec. 2, 2005
Carolina, Puerto Rico
2004
DIA 40th Annual Meeting
June 13-17, 2004
Washington Convention Center
Washington, DC
Best Practices for Risk Management and 21 CFR Part 11 Compliance for Electronic Records
GCP Compliance
April 19-22, 2004
Washington, DC
Abstract
Tyson M. Mew, President, Ofni Systems Inc.
I. Interactive Exercise: Performing Risk and Compliance Assessments
• Build a risk assessment program
• Deciding where and how to assess risk
• Part 11 gap analysis
II. Collecting and Analyzing the Results
• Best practices in collecting and quantifying results
• Deciding where and how to assess risk
• Part 11 gap analysis
III. Corrective and Preventive Actions: Remediation Plans
• Deciding what priority to address first
• Tracking progress
Ensuring Access Databases and Excel Spreadsheets are Part 11 Compliant
IVT Laboratory Controls & Compliance
March 29- April 1st of 2004
Amsterdam, The Netherlands
NH Grand Hotel Krasnapolsky
Abstract
Workshop E • 8:30 am – 12:00 pm
– Dr. Dirk Bissinger, Industrial Operations Drug Products, Quality Assurance Manager, Aventis Pharma Deutschland GmbH
– Ty Mew, President, Ofni Systems Inc.
– Mary Chris Easterly, Technical Manager, QA Validation, Diosynth
– Derek Wimmer, President, Wimmer Systems, LLC.
– David Harrison, Senior Consultant, ABB Eutech.
This seminar presents how to design, build, and validate Access® databases and Excel® spreadsheets in accordance with current practices, including 21 CFR Part 11.
I. Ensuring Access Databases are Part 11 Compliant
• Databases for Part 11 compliance
• Technical controls and functionality
• Securing the Access® environment
• Procedural controls required to be implemented
• Validation of Access® programs
• Demonstrations and case studies
II. Compliance Controls and Excel®- Technical Aspects
• Strengths and weaknesses of Excel®
• How workflow concepts affect design decisions
• Analysis of controls for auditing, authenticity, security, etc.
• Ensuring your solutions will do what you want
III. Risk-Based Validation of Excel® Spreadsheets
• The challenges of validating Excel® spreadsheets
• Integrating Excel® validation into your current CSV practice
• Balancing risk-based validation with efficiency
• Resource requirements, and key learning points for Excel® validation projects
IV. Case Study of Aventis' Use of Excel® Spreadsheets and Preparing and Passing a FDA Inspection
• A pragmatic approach to excel spreadsheet validation
• A general approach on how to get prepared for an inspection
• Strategies for inspections - for inspectors and industry personnel
V. Interactive Exercise
This exercise will be an open question and answer forum for discussing issues related to making Access® databases and Excel® spreadsheets compliant.
2003
How To Make MS Access Programs Part 11 Compliant (audio conference)
October 28, 2003 1:30 PM EST
Download Sample Code References
Abstract
"Firms using Microsoft Access databases for record keeping as part of GxPs need to take the necessary steps to ensure that they are Part 11 compliant. Part 11 demands that you address both technical and procedural requirements. This conference will detail technical controls that must be added, establishing a secure MS Access program, procedural controls that must be implemented and validation. The tools and information provided in the session will benefit anyone who needs to know how to make their systems compliant, as well as those charged with maintaining the integrity of their firm’s critical data. Attendees can also download free code samples that they can use in their own programs."
Ensuring Access Databases and Excel Spreadsheets are Part 11 Compliant
Laboratory Controls and Compliance Conference
August 18-21, 2003
Short Hills, NJ
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