Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

Speaker

Instructor: Carolyn Troiano
Product ID: 706930
Training Level: Intermediate

Location
  • 9
  • October 2023
    Monday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 90 Min
We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.
LIVE ONLINE TRAINING

October 09, Monday 10:00 AM PDT | 01:00 PM EDT
Duration: 90 Min

 

$199.00
One Dial-in One Attendee

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Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

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$399.00

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training
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$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days after completion of Live training
(For multiple locations contact Customer Care)

 

 

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Description

Computerized systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product, or a raw material or packaging component used in conjunction with the product during the manufacturing, testing or tracking processes). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.

It is important to be able to identify computer systems used when performing FDA-regulated activities. When a vendor is involved, whether in terms of provisioning hardware and/or software, implementing the system or maintaining it, this must be done in compliance with FDA requirements. A solid computer system validation strategy, along with an understanding of industry best practices, will lead your company to ensure that vendors are held accountable for delivery of systems and services that will support your efforts to validate computer systems and maintain them in a validated state.

This webinar will also provide guidance on the importance of factoring risk into all FDA-regulated activities, and will help you assess the risk of any computer products purchased from third-party vendors. You will also learn how to develop a standard audit process, using templates and checklists, to ease the burden of this activity. Documentation is critical to proving that a system does what it purports to do, and that a company has thoroughly scrutinized and effectively leveraged any third-party vendor that is involved in these efforts.

Why Should You Attend:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling and distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any computer system governed by FDA regulations, or if you are developing, configuring, maintaining or supporting such a system.

The webinar content is beneficial to both the companies purchasing computer products and services from vendors, and the vendors offering these products and services.

Areas Covered in the Webinar:

  • Vendor Audit
  • Vendor Questionnaire
  • Audit Procedure
  • Audit Checklist
  • Leveraging Vendors
  • Vendor Management
  • FDA GxPs
  • Computer System Validation (CSV) Methodology
  • System Development Life Cycle (SDLC) Framework
  • Risk Management
  • GAMP®5 Good Automated Manufacturing Practice
  • Compliance Strategy
  • Cloud-Based Vendors & Validation
  • Software-as-a-Service (SaaS) Vendors & Validation
  • Infrastructure-as-a-Service (IaaS)
  • Platform-as-a-Service (PaaS)
  • Cost vs. Compliance
  • Industry Best Practices
  • Policies and Procedures
  • Training
  • 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

This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Instructor Profile:
Carolyn Troiano

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 30 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

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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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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