FDA 2011 - Effective Documentation for Compliance in a Regulated Environment
Date2011-12-08
Deadline2011-12-08
VenuePalo Alto, USA - United States
KeywordsFDA Documentation; FDA Compliant Documentation; Documentation Guidelines; Documentation procedure; FDA guidelines; Documentation Standards; document control systems
Topics/Call fo Papers
This 3-hr FDA Documentation training will focus on ideas that will help identify effective methods designed to improve your document control systems, for compliance in a regulated environment.
Why Should You Attend:
Since regulatory inspectors look very closely at critical documentation, it is imperative to develop a standardized and systematic system that ensures proper control and accuracy of your reports, procedures, and other important documents.
Do your reports completely explain the relevant issues?
Are your SOPs accurate, relevant, and useful to your operators?
Do your employees maintain proper control over your documents?
Areas Covered in the Seminar:
- Understand the basis for complete documentation.
- Review the most likely areas for scrutiny.
- Establish effective systems that will pass inspections with ease.
- Define adequate control measures to ensure compliance.
- Determine proper review techniques for records and reports.
- Rehearse effectively for regulatory audits.
NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 6th December 2011.
Why Should You Attend:
Since regulatory inspectors look very closely at critical documentation, it is imperative to develop a standardized and systematic system that ensures proper control and accuracy of your reports, procedures, and other important documents.
Do your reports completely explain the relevant issues?
Are your SOPs accurate, relevant, and useful to your operators?
Do your employees maintain proper control over your documents?
Areas Covered in the Seminar:
- Understand the basis for complete documentation.
- Review the most likely areas for scrutiny.
- Establish effective systems that will pass inspections with ease.
- Define adequate control measures to ensure compliance.
- Determine proper review techniques for records and reports.
- Rehearse effectively for regulatory audits.
NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 6th December 2011.
Other CFPs
- South Korea: Navigating the Regulatory and Clinical Trial Environment
- Incorporate FDA's New Process Validation Principles into Company Verification and Validation Planning
- The International Conference on Cultural Diplomacy in the EU
- China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations)
- SOPs for Clinical Trials ? Regulatory Requirement and Key to Effective Management
Last modified: 2011-11-15 20:54:40