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

Why Should You Attend:

The field of GCP has rapidly evolved over the last few years and the requirements are getting tougher. Many companies find themselves unprepared for a clinical trial audit, either at a clinical site or their headquarters.

This course will help you to prepare early and help to prevent surprises when being audited. Learn to identify risks and handle them to build a more compliant and successful trial.

This training will also share the ”audit experience”, by sharing what auditors look for and how to prepare for the visit. Define expectations, train your staff and hold them accountable and the inspection will be easy to manage. We will describe proactive measures you can take to assure that all systems are in place, operating well and operating in compliance.

Areas Covered in the Seminar:

• What is clinical Audit?
• Audit Vs. Research.
• The Audit Cycle.
• Five stages of Clinical Audit.
• QA Program factors- implementing a program in place.
• What are the risks?
• What a sponsor and investigator need to know about FDA audit?
• Interactive case study to learn about audits.
• Tips for a successful study.
• Preparing for a site visit.
• Most common FDA violations/actions.

Who Will Benefit:

This webinar will provide valuable assistance to all companies/employees (research sites, Clinical research organization, pharmaceutical and biotech industries) that conduct clinical trials.

• Regulatory Affairs
• Clinical Trial staff and management
• Clinical Development
• Project Managers
• Drug Safety staff

Instructor Profile:

Madhavi Diwanji, MBA, CCRC is the President of MD Clinical Monitor. She has tremendous experience in the healthcare industry in various roles for the past 20 years. She is well rounded in all aspects of clinical trial as she has been instrumental in healthcare research with a primary focus on cardiology and oncology. She has experience with monitoring clinical trials, conducting clinical trials, investigator initiated trials, maintaining multiple Trial Master Files, starting a research program in a hospital, health services research, regulatory /compliance submission and management, grant submission, business development and fundraising. She has successfully worked with different IRBs, CROs and sponsors. She has served on a study coordinator advisory committee of a global Congestive Heart failure clinical trial. She currently consults with helping clinical research departments in need services like starting up, regulatory, closing down and increasing productivity.

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