Computer System and Software Validation

Duration: 90 Minutes
We will discuss ways Medical Device manufacturers can organize, document and prepare to present their software validation efforts during FDA Investigations or ISO Registrar audits.
Software Validation
Instructor: Peter Spath
Product ID: 500132
Even before the Electronic Records and Electronic Signature Regulations were promulgated, regulated industries were required to validate computer systems. These requirements are also found in various ISO Standards to which an organization may wish to register. Over the years more processes, equipment, and office systems have become influenced or controlled by computers.

As required by Regulations;
21CFR Part 820.70(i) Automated processes: When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to and established protocol. All software changes shall be validated before approval and issuance. 21CFR Part 11 Electronic Records; Electronic Signatures: This regulation is a minimum set of criteria for controlling records if you choose to use electronic means to create, modify, maintain, archive, retrieve, or transmit any records required by agency regulations.

Why Should you Attend:
Any organization using computer systems to control manufacturing and test equipment, processes, or manage records must validate the software for its intended use. Software validation can appear to be an intimidating endeavor when an organization considers the number of systems in use.

Objectives of the Presentation:
  • What is involved in software validation
  • How to get your validation program started
  • How should an organization decide which systems require validation
  • How does an organization assure their systems are compliant
  • What written procedures and training are required
  • How do FDA Investigators assess compliance
Who can Benefit:
  • Quality Assurance Managers/Personnel
  • Regulatory Managers/Personnel
  • Manufacturing Managers, Supervisors & Personnel
  • IT Personnel
  • Internal Auditors
  • Senior Management Executives (CEO, COO, CFO, etc.)
  • Project Managers
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$375
Recorded Session for one participant
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Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Peter Spath is currently a freelance consultant serving the Medical Device community by providing a variety of quality and regulatory consultation on contractual basis remotely and on-site. Services include: leading Quality System audits in accordance with ISO 9001, 17025, and 13485, Canada's CMDCAS regulations and FDA GMPs for both Medical Devices and Combination Devices. He has over 20 years of experience working with international regulations and standards as a Certified Lead Auditor. Recognized as an expert in ISO Standards and Federal Regulations, especially those governing Electronic Records and Electronic Signatures, he led regulatory compliance assessments throughout Fortune 500 Companies as well as their suppliers across the United States, Mexico, and Europe. Mr. Spath developed and facilitated the implementation of quality management systems in numerous internal organizations and key contract manufacturers in Germany. He has also successfully managed FDA GMP and EPA GLP investigations in a variety of organizations.

In addition to his expertise in Quality Systems and Regulatory requirements for Medical Devices, Mr. Spath has served on EPA committees to develop new regulations for environmental laboratory accreditation. He was also appointed to the Environmental Laboratory Accreditation Board, an EPA Federal Advisory Committee (FACA), providing advice to the EPA Agency Administrator.
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