Looks like this event has already ended.
Check out upcoming events by this organizer, or organize your very own event.
21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s
Tuesday, April 16, 2013 from 10:00 AM to 11:30 AM (PDT)
Palo Alto, CA
This 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs, Product features and Validation (10 step risk based approach).
Why Should You Attend:
This webinar describes exactly what is required to be 21 CFR Part 11 compliant. It takes the concepts of Part 11 and expands them into specific things to do in all three primary areas: SOPs, product features, and validation. All required IT SOPs are described. Product features based on the current industry standards are explained in detail. The 10-step risk-based validation approach is outlined so that the specific documents for a validation project are understood.
This is the first webinar in a series and it takes the mystery out of what is needed for 21 CFR Part 11 compliance. It will help you to eliminate 483s and Warning Letters.
Areas Covered in the Seminar:
- Which data and systems are subject to Part 11.
- What Part 11 means to you, not just what it says in the regulation.
- Avoid 483 and Warning Letters.
- Explore 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.
- 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.
For Registration :
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.