How to Withstand an FDA Audit of your Facility

Why Should You Attend:

If your company is marketing a product or service that is regulated by the FDA, you should be prepared for an FDA audit. If you have never been audited by the FDA or if you were last audited 4-6 years ago, if any product or service you offer has been in the news – positive or negative, or if you are getting ready to submit a clinical trial or marketing approval application, chances are you would get audited by the FDA in the near future. Although different facilities are subject to different regulations, FDA auditors follow some general guidelines that are common across all.

Attend this FDA audit webinar to understand the general rules and know through specific case studies , the common themes and differences across facilities subject to GCP, GMP or GLP regulations. We will also discuss ways to be prepared for an FDA audit, conduct during an audit, and follow-up activities to an audit. It will help you convert an FDA audit into an opportunity to demonstrate high quality products and services, and to increase credibility in the industry for your company.

Learning Objectives:

• GCP/GMP/GLP requirements. Why inspections are conducted and by what statutory authority?
• Reasons for FDA conducting an inspection.
• What to expect from an audit? What is subject to FDA purview and what's off-limits?
• Preparing for the inspection/Audit - What you need to know and do to prepare for, during and even after the inspection, a ctions to be taken upon the investigator's arrival, required documentation, Individual responsibilities for the inspection.
• Do's and don'ts of an FDA audit/Inspection.
• Following up on the audit - What to do next? How to respond to findings and facilitating the documentation and remediation process…and reaching final closure?

Areas Covered in the Seminar:

• Types of FDA audits
• Key guidelines available from FDA
• Preparing for the inspection
• Logistics of the FDA audit
• Follow-up to an FDA audit
• Do's and don'ts of an FDA audit

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• QA/QC/Compliance/ Regulatory affairs professionals
• Senior management executives (CEO, COO, CFO, etc)
• Manufacturing managers, supervisors & personnel
• Clinical and preclinical laboratory managers
• Clinical trial specialists
• Project Managers
• People investing in FDA-regulated product development projects

Instructor Profile:

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( www.amarexcro.com ). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

FDA Audit background:

Each year FDA audits more than 16,000 facilities involved in manufacture, testing or development of food and drug products, and collects more than 25,000 product samples for analysis at its labs. These include not only drugs and biologics but also medical devices, diagnostic kits, dietary supplements, veterinary products, and animal and clinical testing facilities. On an average, the FDA audits result in about 3000 product recalls, 5000 FDA 483s, 500 warning letters, 20,000 products import refusals for non-US manufactured goods, and almost a billion dollars in fines and restitutions. FDA audits are an essential part of assuring compliance with the current regulations. Although most FDA audits are preannounced, FDA does conduct unannounced inspections of facilities that it suspects of noncompliance. The goal of these audits is to assure that products and services available to the American public are of acceptable quality.

FDA audits are very detailed and systemic reviews of a given facility that could span over several days, involve most personnel working at the facility under review, and if evidence of non-compliance is found, could lead to severe restrictions and/or penalties on the responsible parties. More often than not, facilities and personnel are ill-prepared and unaware of the dos and don'ts for an FDA audit and thus get into trouble for easily avoidable errors. Hence, it is very important that at all times FDA-regulated companies be aware of the regulations, logistics, and practical aspects of an FDA audit to be able to successfully withstand the same.