Medical Device Industry Trends for Computer Systems Regulated by FDA

Why Should You Attend:

You should attend this webinar if you are implementing, managing, using or auditing computer systems and/or software involved in medical devices. There may be software used that is in and of itself a medical device – Software as a Medical Device (SaaMD), or software used in conjunction with a physical medical device. Also, software may be used in the manufacture, testing and supply chain activities related to a medical device, and must be validated according to FDA requirements for Computer System Validation (CSV). You will learn about the standards that are driving better compliance and quality in the medical device hardware and software industries.

As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed.

Many medical devices now incorporate software into the system as a component. In other cases, software as a medical device (SaaMD) are manufactured and marketed. In all cases, the validation of the software is critical to ensuring FDA compliance.

Most recently, FDA has noted that 80% of the failures of medical devices incorporating software are due to software updates and patches. FDA is working with industry and other Agency stakeholders to provide a framework for software lifecycle development that will assure application of better standards and practices in the industry.

IEC 62304 provides a framework for developing software code that will result in safe and effective medical device products. It is a risk-based approach that follows the typical SDLC approach for validation, and should be adopted as a standard by any company developing such code or manufacturing medical device products with software as a component.

This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA and is typically housed electronically in computer systems. This includes how to properly validate an FDA-regulated computer system in order to ensure security and data integrity objectives are met. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for Computer System Validation (CSV) and maintaining the system in a validated state throughout its life.

The SDLC approach takes all aspects of validation into account throughout the life of the system and protects the data that it houses through its retention period. The data is a key asset for any FDA-regulated company and must be protected. If data becomes invalid, based on improperly validating and maintaining the system that houses it in a validated state, the work related to the data would need to be repeated. This could result in a devastating loss to any company’s bottom line.

We will also address software used as a component of medical devices and software as a medical device (SaaMD). Some of the recent FDA findings indicate that software companies writing code that must work in conjunction with a medical device or is SaaMD itself is not up to the standards expected for assuring public health. These software companies must adopt a standard SDLC approach, including the necessary change control, to prevent mishaps that are frequently noted with devices that fail after software is patched or updated. FDA is working with industry to develop guidance in this area.

We will discuss the key areas that are most important to assure compliance, including security, data integrity, validation, training, and documentation. The webinar will also address roles and responsibilities, timing of phases and deliverables, change control and audit trails, training and documentation. You will learn what is required not only to validate your system and software, but maintain it in a validated state until it is retired or otherwise no longer in use, particularly through formal change control.

We will cover IEC 62304, including a discussion of how you can meet compliance requirements to assure medical device software is safe and effective for use by consumers.

There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available.

Areas Covered in the Webinar:

• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• “GxP” – Good Manufacturing, Laboratory and Clinical Practices (GMPs, GLPs, GCPs)
• 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
• Data Retention/Archival to ensure security, integrity and compliance
• Validation Strategy/Planning that will take into account the system risk assessment and system categorization (GAMP V) processes
• Software used as a component of a medical device
• Software as a medical device (SaaMD)
• Policies and Procedures
• Critical Training and Organizational Change Management (OCM)
• FDA Regulatory Trends
• FDA Response to Change
• Recent FDA findings for companies in regulated industries
• Recent trends in technology that need to be addressed in the CSV approach
• Industry Best Practices
• Q&A

Who Will Benefit:

This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.

Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Vendors responsible for software development, testing and maintenance
• Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:

• Pharmaceutical
• Medical Device
• Biologicals
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)
• Third-Party companies that support those in the above industries
• Medical Device software developers
• Software as a Medical Device (SaaMD) software developers

Free Materials:

• During the webinar we will discuss FDA Guidance Documents and GAMP5, the Good Automated Manufacturing Practices
• We will discuss the method for assessing risk, based on probability, severity, detectability and mitigation
• There will also be an overview of Policies and Procedures, including a checklist of topics

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

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