ganjyouna.com

This webinar details both regulations and provides details for implementing computerized systems.

Learn exactly what is needed to be compliant for all three primary compliance areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11 and the new European equivalent Annex 11. It gets you on the right track for using electronic records and signatures to greatly increase productivity.

Areas Covered in the Session:

• Which data and systems are subject to the regulations?
• What the regulations mean, not just what they say.
• Avoid 483 and Warning Letters.
• Examine the regulatory requirements for the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
• Ensure data integrity, security, and protect intellectual property.
• Understand the current computer system industry standards for security, data transfer, and audit trails.
• Electronic signatures, digital pens, and biometric signatures.
• Evaluate the regulatory requirements related to the current computer system standards for security, data transfer, audit trails, electronic signatures, digital pens, and biometric signatures.
• SOPs required for the IT infrastructure.
• Product features to look for when purchasing COTS software.
• Reduce validation resources by using easy to understand fill-in-the-blank validation documents.

Who Will Benefit:

• IT
• QA
• QC
• Laboratory staff
• Managers
• GMP, GCP, GLP professionals

David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is “Risk Based Software Validation – Ten easy Steps” that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.

GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.

GlobalCompliancePanel offers a broad range of channels for broadcasting and exchange of information through web based training, web alerts & discussion forums.

GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management. Apart from providing excellent training to compliance professionals by compliance & consulting experts, GlobalCompliancePanel would also focus on providing:

• Information to ensure compliance and enhance quality with regulations for individuals as well as the organizations
• Latest updates on industry trends, industry best practices and any modifications in the regulatory affairs
• One stop destination for all your queries and to share and discuss issues, ideas and best practices and
• A resource on the data sheets, whitepapers, articles, books on industry standards, training kits, software tools, insights, press releases, etc on governance, regulatory, compliances and quality management across different industries.

Article Source: sooperarticles.com/law-articles/regulatory-compliance-articles/21-cfr-part-11-annex-11-what-you-need-know-pass-new-regulatory-audits-673398.html

Author: Smith Ross