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Implementation and Utilization of Standard Operating Procedures (SOPs) at the Clinical Research Site
Wednesday, March 6, 2013 from 10:00 AM to 11:00 AM (PST)
Palo Alto, CA
This webinar will assist clinical research personnel in developing/acquiring SOPs for their site. You will learn how to create a compliant but user–friendly set of SOPs that can pass regulatory audits and also be a useful tool for the site staff.
Why Should You Attend:
ICH GCP guidelines require that all research sites have “Detailed, written instructions to achieve uniformity of the performance of a specific function.” Regulatory agencies are now requiring that every site have a set of SOPs for the elements of clinical research to assure compliance with ICH GCP and ask to review the site’s SOPs during audits.
This course will cover the minimum requirements necessary for SOPs to pass a regulatory audit. It will also offer tips on streamlining the process of development and implementation of SOPs at the site level.
You will learn why SOPs are required at the site level, how to develop SOPs and how to implement them.
Areas Covered in the Webinar:
The webinar will include the following critical information you will need:
- Background information for Site SOPs.
- Required SOPs to pass a regulatory audit.
- How to streamline the process of the development/acquisition of SOPs for the site.
- How to simplify your SOPs for ease of use.
- How to implement SOPs at your site.
- Assuring documentation of training on SOPs.
- Best practices and common errors in writing SOPs.
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.