Utilizing ICH Guidelines for GCP Regulatory Compliance

ICH guidelines provide sponsors of FDA regulated clinical trials with an excellent tool for compliance with FDA GCP regulations and for successfully hosting FDA inspections at clinical sites and at the sponsor. This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. Emphasis is placed on linking ICH guidance documents with FDA regulations in 21 CFR Parts 11, 50, 54, 56, 312, and 812 and understanding the key differences between guidance documents and regulations. Actual case studies from FDA Bioresearch Monitoring inspections are used to explain and clarify ICH guidelines and FDA regulations.

Areas Covered in the seminar:

• What are the top FDA concerns in a GCP Inspection?
• How to use ICH E6 to set up GCP quality systems for a specific clinical trial?
• How to use the E6 Essential Documents section to prevent critical recordkeeping errors?
• What are the most common violations found by FDA investigators at clinical sites?
• What are the most common violations found by FDA investigators at clinical trial sponsors?
• How to develop written procedures for "each stage of data handling"?
• What is the most common problem that causes FDA investigators to lengthen the amount of time spent on the inspection?
• What new concern does FDA have with the conduct of clinical trials?

Who will benefit:

This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials for pharmaceutical, medical device, biotechnology, and biologics products.

• Clinical Development managers and personnel
• Clinical research associates
• Quality assurance managers and auditors
• Clinical Development managers and personnel
• Consultants
• Regulatory Affairs Specialists

Instructor Profile:

Carl Anderson, Anderson is a Tacoma, WA based regulatory affairs and quality assurance consultant in the field of FDA health product approvals including drugs, biologics, and medical devices. From 1987 to 2005 he worked for the United States Food and Drug Administration. In 1994 he began conducting inspections in the Bioresearch Monitoring program and inspected clinical investigators, institutional review boards, nonclinical laboratories, and sponsors of clinical research.

Anderson’s experience also includes postmarketing surveillance of adverse drug experiences and good manufacturing practice of drug products. He was on the FDA’s international inspection cadre and has conducted audits and inspections in Canada, Europe, the Middle East, and East Asia.

Since leaving FDA Anderson assists sponsors of FDA regulated research develop GCP compliant quality systems. He conducts vendor qualification audits, clinical site audits, and audits for sponsor responsibilities. He specializes in conducting “mock FDA” audits to assist in inspection preparedness.

Anderson has made frequent public presentations on good clinical practice, quality assurance, and FDA regulations to professional and industry organizations including the Society of Quality Assurance, Drug Information Association, Regulatory Affairs Professional Society, and Association for Clinical Research Professionals. He also conducts training for private industry as well as public agencies such as the Centers for Disease Control and Prevention (CDC) and university extension services.

Follow us :