Implementing a GCP Vendor Qualification Program: Ensuring your vendors are in compliance with FDA requirements

Sponsors of FDA regulated research face a complex array of clinical trial vendors including clinical laboratories, contract research organizations (CROs), site management organizations (SMOs), and others. Developing and implementing a vendor qualification program is an important due diligence activity to ensure compliance with FDA good clinical practice (GCP) regulations. Sponsors need to understand which regulations apply to the vendors and how conduct effective vendor audits.

An experienced FDA investigator and regulatory consultant takes you through this step-by-step approach that discusses the primary clinical trial vendors, how FDA regulates vendors, and what responsibilities rest squarely on the sponsor. The presentation covers the requirements of the Code of Federal Regulations for drugs, biologics, and medical devices, as well as key FDA Guidance Documents including the International Conference on Harmonization (ICH) E6.

Areas Covered in the seminar:

• Clinical Laboratories: What regulations apply and don’t apply. How to develop an audit plan for clinical laboratories. How to avoid the top three mistakes made by sponsors auditing clinical laboratories. Learn the top federal standard for clinical laboratories.
• Contract Research Organizations: Determine which responsibilities to transfer to a CRO, establish strategies to review a CRO’s past performance and target the SOPs that safeguard your data and ensure regulatory compliance.
• ECG Core Laboratories: How to develop audit standards in the absence of clear regulatory oversight. Includes establishing criteria to qualify a vendor for a "Thorough QT/QTc Study."
• Site Management Organizations: Does FDA regulate SMOs? What every sponsor, and investigator, needs to know when selecting an SMO.
• Institutional Review Boards (IRBs): When should you use a central IRB? What are FDA’s three most common deficiencies cited when inspecting IRBs.
• Outsourcing Data Management: What are the key best practices for clinical data management? What written procedures are critical for maintaining data integrity of your clinical trial?
• Part 11: What computerized systems fall under the jurisdiction of 21 CFR Part 11, FDA’s regulations for electronic records and electronic signatures? What is the current status of FDA enforcement of Part 11?
• Developing an Auditing and Qualification Program: What does your company need to do to implement a quality system for vendor qualification? What written procedures do you need in place? When do you use contract auditors and how do you "qualify the qualifiers?"

Who will benefit:

This program is essential for management of clinical trial sponsors and vendors including:

• Clinical Development
• Regulatory Affairs
• General/Corporate Counsel
• QA/QC
• Purchasing
• Data Management and Statistics
• Drug Safety
• Compliance Officers
• Clinical Laboratories
• Contract Research Organizations
• ECG Core Laboratories
• Institutional Review Boards
• Site Management Organizations

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.

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