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What Are the Current Tools and Best Techniques for (Clinical Trial) Audit/Inspection Preparedness?
Thursday, May 31, 2012 from 10:00 AM to 11:00 AM (EDT)
Palo Alto, CA
This webinar on clinical trial audit/ inspection preparedness will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how you can ensure that the conduct of clinical research at the investigative site(s) complies with them.
Why Should You Attend:
Significant audit/inspection findings expose you and your organization to regulatory or contractual sanctions, including but not limited to – discontinuation, disqualification, seizure, injunction and/or civil money penalties.
Your position, as a clinical research professional, has an important role in your organization’s preparation for and success at audits/inspections, and it is your responsibility to know how to ensure your organization’s readiness for an audit/inspection at all times.
Areas Covered in the Seminar:
- Audits and Inspections: Definitions, Goals, Causes and Procedures.
- Clinical Site Audits/Inspections findings and FDA warning letters.
- Responsibilities of the sponsor, CRO, Investigational site/Investigator.
- Preparation for a planned Audit/Inspection – tools and techniques.
- Appropriate conduct during the Audit/Inspection.
- Completion and follow up after the Audit/inspection.
- DOs and DON'Ts prior to, during and after an Audit/Inspection.
- Implementation of corrective action plan – tools and techniques.
- Ensuring continuous Audit/Inspection preparedness – tools and techniques.
Who Will Benefit:
This webinar will provide valuable assistance to the following Clinical Research Personnel in the Pharma, Biotech and Medical Device industries:
- Sponsor/CRO/Investigative sites General Managers and Directors
- Principal Investigators
- Site Coordinators
- Project Managers
- Clinical Team Managers/Leaders
- Clinical Research Associates / Monitors
- Project Assistants
- Clinical Research Trainers
- Quality Assurance personnel
- Regulatory Compliance Associates and Managers
For Registration :
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.