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Designing a FDA Compliant Quality System
Friday, January 25, 2013 from 10:00 AM to 11:15 AM (PST)
Palo Alto, CA
This quality system design webinar will help you understand how to design a FDA and ISO compliant quality system that fits your company’s quality.
Why Should You Attend:
This webinar will provide the building blocks you will need to develop & maintain your company’s Quality System. It will cover the FDA QSR & ISO requirements. We will discuss required procedures and how to handle company specific exclusion to the Quality System. After taking this webinar you will have an understanding of the FDA QSR & ISO requirements and how to develop and implement them for your company.
All functional groups who have Quality Assurance responsibility or need to understand the basics of Quality System development and implementation should attend.
Areas Covered in the Seminar:
- Overview of the FDA Quality System Regulations
- Overview of the ISO 13485 & 9001 requirements
- Performing a Gap Analysis of your company Quality System
- Determining the appropriate SOPs
- Deciding on QSR exclusions
- Communicating with Affected Department Managers
- Simple vs Complex SOPs
- Implementing the Quality System
- Auditing the Quality System
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.