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How to withstand an FDA audit of your facility
Instructor:

Product ID:
500033


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Duration: 60 Minutes
$288.00 Recorded Session
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$489.00 Training CD
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Description:
Learning how convert an FDA audit into an opportunity to demonstrate high quality products and services, and to increase credibility in the industry for your company.
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.

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. We will discuss the general rules and specific case studies to highlight the common themes and differences across facilities subject to GCP, GMP or GLP regulations.

This seminar will discuss ways to be prepared for an FDA audit, conduct during an audit, and follow-up activities to an audit. Topics covered include
  • 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 an audit. What you need to know and do to prepare for, during and even after the inspection, actions to be taken upon the investigator's arrival, required documentation, Individual responsibilities for the inspection
  • Do's and Don'ts of the 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?
Objectives of the Presentation:
  • 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 can 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
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993