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A Systematic Approach To Writing Effective Standard Operating Procedures (SOPs)
Friday, March 8, 2013 from 10:00 AM to 11:30 AM (PST)
Palo Alto, CA
This FDA compliant SOPs training will explain how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure FDA compliance in a way that is concise, reproducible and easy to follow.
Why Should You Attend:
Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Yet there is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. Worse, this often leads to many regulatory errors that first come to light during an audit by an agency such as the FDA. Resolution of the audit findings then costs many hours of effort and many thousands of dollars.
This 90-minute session will show you how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure compliance in a way that is concise, reproducible and easy to follow.
Areas Covered in the Seminar:
- SOPs and their relation to the regulations.
- SOPs as part of the company's regulatory infrastructure.
- SOP on SOPs and how to ensure conciseness, consistency and ease of use.
- Risk Based approach on SOP Best Practices for creation and maintenance.
- Training on SOPs.
- Tools for SOP tracking and when is validation required.
- What the FDA looks for in SOPs during an inspection.
Date: March 08, 2013
Time: 10:00 AM-11:30 AM PST
Cost: $299 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
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.