The new Part 11 inspections: requirements for validation and SaaS/Cloud applications.

Image credit: Self
Schedule Tuesday, February 15, 2022 || 10:00 AM PST | 01:00 PM EST
Duration 90 Mins
Level Basic & Intermediate & Advanced
Webinar ID IQW22B0203

  • How to write a Data Privacy Statement
  • SOPs required for the IT infrastructure
  • Avoid 483 and Warning Letters
  • Requirements for local, SaaS, and cloud hosting
  • What the regulations mean, not just what they say
  • Which data and systems are subject to Part 11 and Annex 11
  • Product features to look for when purchasing COTS software
  • How to use electronic signatures, ensure data integrity, and protect intellectual property
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents
  • Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures

Overview of the webinar

  • Details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation
  • This highly interactive training uses life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing and maintaining computer systems in regulated environments
  • The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Understand the specific requirements associated with local and SaaS/cloud hosting solutions

Who should attend?

  • GMP, GCP, GLP, Regulatory Professionals
  • QA/QC
  • IT
  • Auditors
  • Managers and Directors
  • Audit Managers
  • Chief Audit Executives
  • External auditors/Internal Auditors
  • Software Vendors, Hosting Providers
  • Audit committee members

Why should you attend?

  • Explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR)
  • This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud-hosted applications
  • What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation
  • It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance

Faculty - Mr.David Nettleton

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. 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. He has completed more than 225 mission critical laboratory, clinical, and manufacturing software implementation projects. Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory audits: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.


Refund / Cancellation policy
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