Medical Device Industry Trends for Computer Systems Regulated by FDA

Instructor: Carolyn Troiano
Product ID: 706334
Training Level: Intermediate
  • Duration: 90 Min
FDA requires that all computer systems used to produce, manage and report data for “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
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Why Should You Attend:

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Also, if you are developing and supporting software that is used in conjunction with a medical device or is considered to be software as a medical device, you will benefit from this session.

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.

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).

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

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
Instructor Profile:
Carolyn Troiano

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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