7 Courses on FDA Inspections and FDA Audits

FDA compliance is one of the most vital subjects for any organization as, without it, their credentials will certainly be called into question. This comprehensive webinar series will prioritize FDA standards and best practices that apply to all industries in the life science scope.
Instructor: Luis Chavarria, Mukesh Kumar, David Lim, Casper E Uldriks
Product ID: PACK70005

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations.
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants, as you wish.
  • Recording links will be valid up to 6 months with unlimited access and reference materials will be mailed to your registered e-mail.
  • Free shipment of CDs within 72 hours from the date of purchase and reference materials will be mailed to your registered address.

Webinar Topics:


Who will benefit?

These webinar will be beneficial to the following:

CEO/VP | Attorneys | R&D | Anyone Interested in the FDA inspection Process | QA/QC/Compliance/Regulatory affairs professionals | Manufacturing managers, supervisors & personnel | Clinical and preclinical laboratory managers | Regulatory Affairs | Legal Counsel for Product Liability | Sales and Marketing Executives | Senior Operations and Finance Executives | In-house Legal Counsel | FDA Consultants | Public Relations Professionals


Webinars included in the Package:

FDA Investigations and Inspections (Duration: 90 Minutes)

How FDA conducts investigations and inspections. Learn about the tools and procedures the FDA uses to conduct investigations and inspections from a former retired FDA Office of Regulatory Affairs officer.

Areas Covered in the Webinar:

The objective of the presentation is to introduce the audience to the investigation and inspection process from a former regulator’s view to better prepare yourself to handle investigations and inspections.

Instructor Profile:

Mr. Luis Chavarria recently retired from the United States Food and Drug Administration (FDA) after more than 30 years of service. His unique career covered numerous national and international assignments. Starting with the position of Consumer Safety Inspector and ending with the position of Assistant Regional Director for Latin America in the Office of the Commissioner.


How FDA Inspection Observations are Reviewed for Regulatory Action (Duration: 60 Minutes)

The presentation covers the different steps in processing observaions and evidence collected during an inspection for possible regulatory action. Hundreds of Domestic and Foreign Companies are inspected by the FDA and the inspection result in regulatory actions that greatly impact the firm's reputation and business. Learn what steps are involved in the process.

Areas Covered in the Webinar:

Prepare the company to deal with the development of possible regulatory action.

Instructor Profile:

Mr. Luis Chavarria recently retired from the United States Food and Drug Administration (FDA) after more than 30 years of service. His unique career covered numerous national and international assignments. Starting with the position of Consumer Safety Inspector and ending with the position of Assistant Regional Director for Latin America in the Office of the Commissioner.


How to withstand an FDA audit of your facility (Duration: 60 Minutes)

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.

Areas Covered in the Webinar:

  • 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

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.


FDA Inspection: Preparation and Management (Duration: 60 Minutes)

This webinar discusses emotional intelligence (EQ)-based practical and actionable guidance on how to proactively prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don'ts before, during and after the inspection. At the end of the webinar, you will get empowered in an effective way that you would proactively prepare for and confidently manage the FDA inspection process including the inspection response.

Areas Covered in the Webinar:

  • FDA Authority and Regulations
  • Field Management Directives
  • Investigations Operations Manual
  • Inspection Guides
  • Compliance Program Guidance Manual
  • How to Host an FDA Inspection
  • Inspection Types and Categories
  • Inspection Classification
  • Inspection Process
  • FDA Forms 482 and 483
  • Inspection Response
  • What/How to Prepare for and to Manage an FDA Inspection
  • How to Communicate Before, During and After inspection: Dos and Don'ts
  • Case studies
  • Conclusion

Instructor Profile:

Dr David Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc.,


Practical Guide to FDA Inspections (Duration: 60 Minutes)

FDA's standard inspectional operations are discussed in the webinar so you can establish or revised your FDA inspection protocol before an inspection occurs. Most FDA inspections follow a standard procedure.
You will learn the basic elements of how FDA prepares, conducts and evaluates inspections. With that information, you can establish, revise or test your FDA inspection protocol. An effective protocol can place you in the best possible light for your circumstances and ideally avoid misunderstandings that have costly outcomes.

Areas Covered in the Webinar:

  • How FDA selects firms for inspection
  • The level of inspectional rigor applied
  • The FDA forms used and what they mean
  • Discussions and interviews with firm personnel
  • Regulatory deviations (inspectional observations)
  • FDA's evaluation and classification of an inspection

Instructor Profile:

Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.


FDA Warning Letter Management (Duration: 60 Minutes)

When the FDA documents that a firm has significant deviations from applicable legal requirements, it will issue that firm a Warning Letter. As an enforcement tool, the FDA Warning Letter tells you that your firm is facing harsh enforcement action unless you correct the errors of your ways. What you say and, more importantly, what you do can make or break your future with the FDA. The Warning Letter is a regulatory spring board that leads you into treacherous waters. Currently, the FDA aggressively manages Warning Letters. The threat of further legal action is real. You have little, if any, breathing room for mistakes or oversights in your response. By effectively managing your Warning Letter response, you can avoid being a statistic for other legal actions, like seizure, injunction, prosecutions, fines and product detention.

Areas Covered in the Webinar:

  • Gauging the likelihood of receiving a Warning Letter
  • Preparing for a Warning Letter
  • Interpreting a Warning Letter as a "micro" and "macro" problem
  • How and when to respond a Warning Letter
  • Interacting with FDA staff
  • Immediate, intermediate and long term business impact
  • Warning Letter Post Mortem
  • Mapping your regulatory future.

Instructor Profile:

Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.


The Infamous Form FDA 483: How you respond can make or break you (Duration: 60 Minutes)

The infamous Form FDA 483 (483) presents a list of observations noted by an FDA investigator, a consumer safety officer (CSO,) during the inspection of an establishment regulated by the FDA. The observations point out specific factual situations that in the investigator's view demonstrate an apparent violation of the applicable FDA regulations. The issuance of a 483 by the CSO at the conclusion of an inspection will be discussed with the establishment's management and put them on notice that the nonconformities warrant correction and that a failure to do so may result in further action by the FDA, such as civil money penalties, seizure, injunction, and/or prosecution. Firm's are well advised to take the warning seriously.

Areas Covered in the Webinar:

  • What the Form FDA "483" means
  • How to manage the FDA's 483 observations during and after an inspection
  • What the FDA considers important
  • How to respond effectively to 483 observations
  • Plan for the wake of problems generated by a 483
  • Learn how to restore, or destroy, your regulatory profile with the FDA

Instructor Profile:

Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.

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