Clinical Trial auditing - Identifying risks and building a more compliant and successful trial

The field of GCP has rapidly evolved over the last 5 years and the requirements are getting tougher. Many companies find themselves unprepared for an FDA or EMEA inspection either at a clinical site or their headquarters. To prevent the surprises, early preparation is essential. Define expectations, train your staff and hold them accountable and the inspection will be easy to manage. This webinar will describe proactive measures you can take to assure that all systems are in place, operating well and operating in compliance. This will result in trials running smoothly, data being valid and giving your drug the best chance of success in the clinic leading to approval.

Areas Covered in the seminar:

• What the major systems that must be in place - the requirements.
• Ways to determine how well your systems are designed.
• Ways to determine how well your systems are operating.
• Major pitfalls that companies run into.
• If I use a CRO, how much oversight is enough.
• How do I manage sites, do I have to audit them all?
• How do I manage an ex USA site.
• How can I get processes that everybody will follow.

Who will benefit:

This webinar will provide valuable assistance to all companies that conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. The employees who will benefit include:

• QA GCP staff
• Regulatory Affairs
• Clinical Operations
• Clinical Development
• Project Managers
• Drug Safety staff

Instructor Profile:
Peter Calcott, Ph.D. is founder and President of Calcott Consulting which serves the biotech, Pharma and venture capital industry. It provides consulting services in supply chain development and management, quality systems development and implementation, clinical development and monitoring, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.