Regulatory Focus for Computer System Validation
Friday, January 25, 2013 from 10:00 AM to 11:00 AM (PST)
Palo Alto, CA
This computer system validation training will provide the basic building blocks you will need to develop & maintain your company’s validation and compliance program. It will cover the practical entry requirements and operations, principles of risk-based computer system validation.
Why Should You Attend:
The FDA’s General Principles of Software Validation (GPSV), emphasizing how crucial requirements are to successful validation, recognizes that the requirements for a successful validation project are difficult, if not impossible, to create accurately and to an adequate level of detail in one pass.
The recognition that requirements are “defined, refined, and updated as a development project progresses” indicates that the FDA clearly understands that it is unlikely that a project team will be able to adhere strictly to a traditional waterfall life cycle management model.
This webinar will explain the criteria for software-based applications established by the FDA and other regulatory agencies, developed for use within the pharmaceutical, biological, and medical device industries. The session will provide the basic building blocks you will need to develop & maintain your company’s validation and compliance program. It will cover the practical entry requirements and operations, principles of risk-based computer system validation.
Areas Covered in the Seminar:
- Regulatory requirements of CSV
- Development of documentation as required by regulations.
- Electronic Records and Signatures
- FDA's new 21 CFR Part 11 Guidance, how to use it and why it is important.
- FDA's new risk-based approach
- GAMP 5 New Computer System Validation
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.