Compliance Online are hosting a two-day in-person entitled ‘Computer System Validation - Reduce Costs and Avoid 483s’, which will run from the 2nd to the 3rd of November in San Francisco, CA, United States.
This Computer System Validation Training seminar is designed to explore the proven techniques used to reduce costs associated with the implementation, usage and maintenance of computer systems in regulated environments.
Q.1 - What is the focus of this seminar and why is it being offered? What makes this seminar unique compared to others on Computer System Validation courses?
The seminar provides step-by-step details for all four primary areas of 21 CFR Part 11. Further, it details how to apply the requirements of Part 11/Annex 11 to Software as a Service/Cloud computing. There is no other instructional experience available that is this comprehensive.
Q.2 - Who should attend this seminar and what can they expect from it? What are the benefits of attending? How is the day scheduled?
The seminar contains a series of interactive lectures and workshops. It is ideal for QA, IT, managers, executives, CROs, software vendors, and regulatory affairs professional. Participants learn their responsibilities for compliance.
Q.3 - Who is speaking at the seminar and what is their background in the topic? What kind of insights will they provide for attendees? Why were they chosen?
Computer System Validation’s principal, David Nettleton, is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.
Q.4 - How often is this seminar held? Do you have any highlights from past conferences? What do you hope attendees will take away from this conference?
The seminar is held in a public forum five times per year, and is taught within companies every month. Participants are readily able to apply what they have learned to improve the efficiency and productivity of their compliance efforts.
This seminar offers participants the most comprehensive learning experience on the four primary areas of 21 CFR Part 11, plus Part 11/Annex 11 to Software as a Service/Cloud computing requirements.
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