Share Your Research, Maximize Your Social Impacts
Main Menu
Searching By
PARTNERS
Clinical Compliance 2012 - SOPs for Clinical Trials ? Regulatory Requirement and Key to Effective Management
Date2012-01-19
Deadline2012-01-19
VenuePalo Alto, USA - United States 
KeywordsSOPs for Clinical Trials; ICH-GCP requirements; ISO 14155 requirements for SOPs; Standard Operating Procedures; Clinical Trial Report; SOPs features; SOPs samples
Topics/Call fo Papers
This SOPs for Clinical Trials training will cover ICH-GCP and ISO 14155 requirements for SOPs. It will outline steps to effectively develop and maintain SOPs and manage risks to your clnical research operation, through their use.
Why Should You Attend:
Failure to establish, maintain and adhere to written SOPs for Clinical Trials, expose the organization to Regulatory actions. These actions include, but are not limited to, seizure, injunction and/or civil money penalties and might even result in project/s discontinuation.
Areas Covered in the Seminar:
- ICH-GCP and ISO 14155 requirements for SOPs.
- Management Responsibilities for the development, maintenance and compliance with SOPs.
- Inspection findings related to SOPs.
- Risk management through the use of SOPs.
- Required features of SOPs.
- SOPs samples/templates.
- Benefits of efficient development, maintenance and use of SOPs.
Why Should You Attend:
Failure to establish, maintain and adhere to written SOPs for Clinical Trials, expose the organization to Regulatory actions. These actions include, but are not limited to, seizure, injunction and/or civil money penalties and might even result in project/s discontinuation.
Areas Covered in the Seminar:
- ICH-GCP and ISO 14155 requirements for SOPs.
- Management Responsibilities for the development, maintenance and compliance with SOPs.
- Inspection findings related to SOPs.
- Risk management through the use of SOPs.
- Required features of SOPs.
- SOPs samples/templates.
- Benefits of efficient development, maintenance and use of SOPs.
Other CFPs
- FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program
- Fundamentals of Clinical Research - Key players and roles for a successful and compliant research team
- The GCP/ICH Obligations of Sponsors, Monitors, and Investigators - Barriers and Solutions
- Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
- Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)
Last modified: 2011-11-15 19:53:37